Trial Outcomes & Findings for Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults (NCT NCT01802151)
NCT ID: NCT01802151
Last Updated: 2015-12-17
Results Overview
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
Weekly for 6 weeks
Results posted on
2015-12-17
Participant Flow
Healthy adults were recruited by flyers and word of mouth on the University of Florida campus. Rolling recruitment (7/02/2012-08/23/2012) occurred until the minimum number of participants (n=80) had been enrolled.
A one week baseline period was to be completed before participants were randomized to intervention arms. Participants that failed to complete study requirements during this period were withdrawn due to noncompliance.
Participant milestones
| Measure |
Placebo
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
21
|
22
|
20
|
|
Overall Study
COMPLETED
|
20
|
21
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Bacillus Subtilis R0179 in Healthy Young Adults
Baseline characteristics by cohort
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
23 years
n=5 Participants
|
23 years
n=7 Participants
|
22 years
n=5 Participants
|
23 years
n=4 Participants
|
23 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
42 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
7 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
13 participants
n=5 Participants
|
14 participants
n=4 Participants
|
45 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
81 participants
n=21 Participants
|
|
BMI Percentiles
<85th % (Healthy Weight)
|
10 participants
n=5 Participants
|
12 participants
n=7 Participants
|
13 participants
n=5 Participants
|
9 participants
n=4 Participants
|
44 participants
n=21 Participants
|
|
BMI Percentiles
85th-94th % (Overweight)
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
4 participants
n=5 Participants
|
9 participants
n=4 Participants
|
26 participants
n=21 Participants
|
|
BMI Percentiles
>= 95th % (Obese)
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
2 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
Activity Level
|
185.5 mins of moderate and intense activity
STANDARD_DEVIATION 70.9 • n=5 Participants
|
197.3 mins of moderate and intense activity
STANDARD_DEVIATION 84.5 • n=7 Participants
|
168.3 mins of moderate and intense activity
STANDARD_DEVIATION 74.9 • n=5 Participants
|
199.0 mins of moderate and intense activity
STANDARD_DEVIATION 57.9 • n=4 Participants
|
185.9 mins of moderate and intense activity
STANDARD_DEVIATION 72.4 • n=21 Participants
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress
Daily Questionnaire (GI Distress) Week 1
|
0.5 units on a scale
Standard Error 0.8
|
0.3 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.1
|
0.7 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress
Daily Questionnaire (GI Distress) Week 2
|
0.5 units on a scale
Standard Error 0.1
|
0.4 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress
Daily Questionnaire (GI Distress) Week 4
|
0.6 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.01
|
0.7 units on a scale
Standard Error 0.1
|
0.7 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress
Daily Questionnaire (GI Distress) Week 3
|
0.6 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress
Daily Questionnaire (GI Distress) Week 5
|
0.6 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.1
|
0.7 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress
Daily Questionnaire (GI Distress) Week 6
|
0.5 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.1
|
0.4 units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic
Daily Questionnaire (Cephalic) Week 1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.04
|
0.2 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic
Daily Questionnaire (Cephalic) Week 2
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.04
|
0.2 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic
Daily Questionnaire (Cephalic) Week 3
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.04
|
0.3 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic
Daily Questionnaire (Cephalic) Week 4
|
0.4 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.03
|
0.2 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic
Daily Questionnaire (Cephalic) Week 6
|
0.2 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic
Daily Questionnaire (Cephalic) Week 5
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal
Daily Questionnaire (Epidermal) Week 1
|
0.1 units on a scale
Standard Error 0.02
|
0.1 units on a scale
Standard Error 0.1
|
0.01 units on a scale
Standard Error 0.01
|
0.03 units on a scale
Standard Error 0.01
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal
Daily Questionnaire (Epidermal) Week 2
|
0.1 units on a scale
Standard Error 0.04
|
0.02 units on a scale
Standard Error 0.01
|
0.04 units on a scale
Standard Error 0.02
|
0.04 units on a scale
Standard Error 0.02
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal
Daily Questionnaire (Epidermal) Week 3
|
0.04 units on a scale
Standard Error 0.03
|
0.1 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.04
|
0.05 units on a scale
Standard Error 0.03
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal
Daily Questionnaire (Epidermal) Week 5
|
0.1 units on a scale
Standard Error 0.04
|
0.02 units on a scale
Standard Error 0.01
|
0.02 units on a scale
Standard Error 0.02
|
0.02 units on a scale
Standard Error 0.02
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal
Daily Questionnaire (Epidermal) Week 6
|
0.1 units on a scale
Standard Error 0.04
|
0.02 units on a scale
Standard Error 0.02
|
0.01 units on a scale
Standard Error 0.01
|
0.02 units on a scale
Standard Error 0.02
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal
Daily Questionnaire (Epidermal) Week 4
|
0.1 units on a scale
Standard Error 0.04
|
0.02 units on a scale
Standard Error 0.01
|
0.1 units on a scale
Standard Error 0.1
|
0.04 units on a scale
Standard Error 0.02
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)
Daily Questionnaire (ENT) Week 1
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.4
|
0.1 units on a scale
Standard Error 0.04
|
0.1 units on a scale
Standard Error 0.04
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)
Daily Questionnaire (ENT) Week 2
|
0.3 units on a scale
Standard Error 0.2
|
0.4 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.03
|
0.1 units on a scale
Standard Error 0.04
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)
Daily Questionnaire (ENT) Week 3
|
0.3 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)
Daily Questionnaire (ENT) Week 4
|
0.4 units on a scale
Standard Error 0.2
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)
Daily Questionnaire (ENT) Week 5
|
0.3 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)
Daily Questionnaire (ENT) Week 6
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral
Daily Questionnaire (Behavioral) Week 1
|
0.5 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral
Daily Questionnaire (Behavioral) Week 2
|
0.4 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral
Daily Questionnaire (Behavioral) Week 3
|
0.4 units on a scale
Standard Error 0.2
|
0.1 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral
Daily Questionnaire (Behavioral) Week 4
|
0.4 units on a scale
Standard Error 0.2
|
0.1 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.01
|
0.5 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral
Daily Questionnaire (Behavioral) Week 5
|
0.6 units on a scale
Standard Error 0.2
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral
Daily Questionnaire (Behavioral) Week 6
|
0.4 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.2
|
0.2 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic
Daily Questionnaire (Emetic) Week 1
|
0.05 units on a scale
Standard Error 0.04
|
0.003 units on a scale
Standard Error 0.003
|
0.1 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic
Daily Questionnaire (Emetic) Week 2
|
0.1 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.04
|
0.1 units on a scale
Standard Error 0.04
|
0.03 units on a scale
Standard Error 0.01
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic
Daily Questionnaire (Emetic) Week 3
|
0.1 units on a scale
Standard Error 0.04
|
0.1 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic
Daily Questionnaire (Emetic) Week 4
|
0.1 units on a scale
Standard Error 0.1
|
0.02 units on a scale
Standard Error 0.02
|
0.1 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.04
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic
Daily Questionnaire (Emetic) Week 5
|
0.1 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.03
|
0.1 units on a scale
Standard Error 0.1
|
0.03 units on a scale
Standard Error 0.02
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic
Daily Questionnaire (Emetic) Week 6
|
0.1 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
0.08 units on a scale
Standard Error 0.04
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation
Daily Questionnaire (Constipation) Week 1
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
0.4 units on a scale
Standard Error 0.2
|
0.4 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation
Daily Questionnaire (Constipation) Week 2
|
0.1 units on a scale
Standard Error 0.04
|
0.2 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.1
|
0.7 units on a scale
Standard Error 0.3
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation
Daily Questionnaire (Constipation) Week 3
|
0.3 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.01
|
0.3 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation
Daily Questionnaire (Constipation) Week 4
|
0.3 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.2
|
0.7 units on a scale
Standard Error 0.3
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation
Daily Questionnaire (Constipation) Week 5
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
0.5 units on a scale
Standard Error 0.1
|
0.7 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation
Daily Questionnaire (Constipation) Week 6
|
0.3 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.03
|
0.5 units on a scale
Standard Error 0.2
|
0.5 units on a scale
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea
Daily Questionnaire (Diarrhea) Week 6
|
0.3 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.04
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea
Daily Questionnaire (Diarrhea) Week 1
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.04
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea
Daily Questionnaire (Diarrhea) Week 2
|
0.2 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.03
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.03
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea
Daily Questionnaire (Diarrhea) Week 3
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea
Daily Questionnaire (Diarrhea) Week 4
|
0.2 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
0.4 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea
Daily Questionnaire (Diarrhea) Week 5
|
0.4 units on a scale
Standard Error 0.1
|
0.2 units on a scale
Standard Error 0.1
|
0.3 units on a scale
Standard Error 0.1
|
0.1 units on a scale
Standard Error 0.1
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue
Daily Questionnaire (Fatigue) Week 1
|
1.1 units on a scale
Standard Error 0.3
|
0.7 units on a scale
Standard Error 0.2
|
0.7 units on a scale
Standard Error 0.2
|
0.8 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue
Daily Questionnaire (Fatigue) Week 2
|
0.9 units on a scale
Standard Error 0.3
|
0.6 units on a scale
Standard Error 0.2
|
0.7 units on a scale
Standard Error 0.2
|
0.9 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue
Daily Questionnaire (Fatigue) Week 3
|
0.9 units on a scale
Standard Error 0.3
|
0.6 units on a scale
Standard Error 0.2
|
0.7 units on a scale
Standard Error 0.2
|
0.9 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue
Daily Questionnaire (Fatigue) Week 4
|
1.0 units on a scale
Standard Error 0.3
|
0.4 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.2
|
0.9 units on a scale
Standard Error 0.3
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue
Daily Questionnaire (Fatigue) Week 5
|
0.8 units on a scale
Standard Error 0.3
|
0.5 units on a scale
Standard Error 0.1
|
0.6 units on a scale
Standard Error 0.2
|
0.8 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue
Daily Questionnaire (Fatigue) Week 6
|
0.6 units on a scale
Standard Error 0.3
|
0.5 units on a scale
Standard Error 0.2
|
0.5 units on a scale
Standard Error 0.2
|
0.7 units on a scale
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety
Daily Questionnaire (Satiety) Week 2
|
0.7 units on a scale
Standard Error 0.2
|
0.3 units on a scale
Standard Error 0.1
|
0.8 units on a scale
Standard Error 0.2
|
1.1 units on a scale
Standard Error 0.3
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety
Daily Questionnaire (Satiety) Week 3
|
0.9 units on a scale
Standard Error 0.3
|
0.3 units on a scale
Standard Error 0.1
|
0.8 units on a scale
Standard Error 0.2
|
0.9 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety
Daily Questionnaire (Satiety) Week 4
|
0.9 units on a scale
Standard Error 0.3
|
0.3 units on a scale
Standard Error 0.1
|
0.8 units on a scale
Standard Error 0.2
|
1.0 units on a scale
Standard Error 0.3
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety
Daily Questionnaire (Satiety) Week 5
|
0.9 units on a scale
Standard Error 0.3
|
0.4 units on a scale
Standard Error 0.1
|
0.9 units on a scale
Standard Error 0.3
|
0.9 units on a scale
Standard Error 0.3
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety
Daily Questionnaire (Satiety) Week 6
|
0.8 units on a scale
Standard Error 0.3
|
0.3 units on a scale
Standard Error 0.1
|
0.9 units on a scale
Standard Error 0.3
|
0.8 units on a scale
Standard Error 0.3
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety
Daily Questionnaire (Satiety) Week 1
|
0.8 units on a scale
Standard Error 0.2
|
0.7 units on a scale
Standard Error 0.2
|
0.9 units on a scale
Standard Error 0.2
|
0.9 units on a scale
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement
Daily Questionnaire (Bowel Mov.) Week 1
|
1.55 units on a scale
Standard Error 0.2
|
1.5 units on a scale
Standard Error 0.2
|
1.3 units on a scale
Standard Error 0.1
|
1.5 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement
Daily Questionnaire (Bowel Mov.) Weeks 2-5
|
1.4 units on a scale
Standard Error 0.1
|
1.5 units on a scale
Standard Error 0.1
|
1.5 units on a scale
Standard Error 0.1
|
1.5 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement
Daily Questionnaire (Bowel Mov.) Week 6
|
1.5 units on a scale
Standard Error 0.2
|
1.4 units on a scale
Standard Error 0.1
|
1.4 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Weekly for 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire.
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep
Daily Questionnaire (Hours of Sleep) Week 1
|
6.8 Hours
Standard Error 0.2
|
6.6 Hours
Standard Error 0.2
|
7.1 Hours
Standard Error 0.1
|
6.6 Hours
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep
Daily Questionnaire (Hours of Sleep) Week 2
|
6.7 Hours
Standard Error 0.1
|
6.8 Hours
Standard Error 0.2
|
7.1 Hours
Standard Error 0.2
|
6.9 Hours
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep
Daily Questionnaire (Hours of Sleep) Week 3
|
6.5 Hours
Standard Error 0.2
|
6.8 Hours
Standard Error 0.2
|
7.1 Hours
Standard Error 0.2
|
6.7 Hours
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep
Daily Questionnaire (Hours of Sleep) Week 4
|
6.6 Hours
Standard Error 0.2
|
7.0 Hours
Standard Error 0.2
|
7.3 Hours
Standard Error 0.2
|
6.8 Hours
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep
Daily Questionnaire (Hours of Sleep) Week 5
|
6.8 Hours
Standard Error 0.2
|
7.0 Hours
Standard Error 0.2
|
6.9 Hours
Standard Error 0.2
|
6.9 Hours
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep
Daily Questionnaire (Hours of Sleep) Week 6
|
6.8 Hours
Standard Error 0.2
|
7.0 Hours
Standard Error 0.2
|
7.1 Hours
Standard Error 0.1
|
6.7 Hours
Standard Error 0.2
|
PRIMARY outcome
Timeframe: Weeks 1, 5, and 6Population: Participants who completed all study requirements were included in the baseline analysis population.
Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Abdominal Pain) Week 1
|
1.6 units on a scale
Standard Error 0.1
|
1.3 units on a scale
Standard Error 0.1
|
1.4 units on a scale
Standard Error 0.1
|
1.5 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Abdominal Pain) Week 5
|
1.8 units on a scale
Standard Error 0.1
|
1.5 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Abdominal Pain) Week 6
|
1.7 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.2
|
1.6 units on a scale
Standard Error 0.1
|
1.3 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Reflux) Week 1
|
1.3 units on a scale
Standard Error 0.1
|
1.3 units on a scale
Standard Error 0.2
|
1.1 units on a scale
Standard Error 0.1
|
1.1 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Reflux) Week 5
|
1.3 units on a scale
Standard Error 0.1
|
1.3 units on a scale
Standard Error 0.2
|
1.1 units on a scale
Standard Error 0.1
|
1.2 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Diarrhea) Week 1
|
1.3 units on a scale
Standard Error 0.1
|
1.2 units on a scale
Standard Error 0.1
|
1.3 units on a scale
Standard Error 0.2
|
1.4 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Diarrhea) Week 5
|
1.7 units on a scale
Standard Error 0.2
|
1.2 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.2
|
1.5 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Diarrhea) Week 6
|
1.8 units on a scale
Standard Error 0.2
|
1.3 units on a scale
Standard Error 0.1
|
1.4 units on a scale
Standard Error 0.2
|
1.3 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Reflux) Week 6
|
1.3 units on a scale
Standard Error 0.1
|
1.3 units on a scale
Standard Error 0.2
|
1.1 units on a scale
Standard Error 0.1
|
1.2 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Indigestion) Week 1
|
1.8 units on a scale
Standard Error 0.1
|
1.4 units on a scale
Standard Error 0.1
|
1.5 units on a scale
Standard Error 0.01
|
1.7 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Indigestion) Week 5
|
1.9 units on a scale
Standard Error 0.2
|
1.6 units on a scale
Standard Error 0.1
|
1.9 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Indigestion) Week 6
|
1.9 units on a scale
Standard Error 0.1
|
1.3 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.1
|
1.7 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Constipation) Week 1
|
1.5 units on a scale
Standard Error 0.1
|
1.1 units on a scale
Standard Error 0.1
|
1.4 units on a scale
Standard Error 0.1
|
1.4 units on a scale
Standard Error 0.1
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Constipation) Week 5
|
1.6 units on a scale
Standard Error 0.1
|
1.2 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.2
|
1.8 units on a scale
Standard Error 0.2
|
|
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
GSRS (Constipation) Week 6
|
1.5 units on a scale
Standard Error 0.1
|
1.2 units on a scale
Standard Error 0.1
|
1.6 units on a scale
Standard Error 0.2
|
1.7 units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Participants who completed all study requirements were included in the baseline analysis population.
Viability of B. subtilis R0179, recovered from stool samples, was assessed using one way ANOVA followed subsequently by Tukey-Kramer HSD when significance was reached (p\<0.05). Data was normalized when appropriate. Data analyzed was log (CFU/g).
Outcome measures
| Measure |
Placebo
n=20 Participants
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 Participants
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 Participants
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)
GI Viability of Bacillus Spores Week 1
|
0.9 log CFU/g
Standard Error 0.1
|
0.9 log CFU/g
Standard Error 0.1
|
0.9 log CFU/g
Standard Error 0.1
|
1.2 log CFU/g
Standard Error 0.2
|
|
Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)
GI Viability of Bacillus Spores Week 5
|
1.1 log CFU/g
Standard Error 0.1
|
4.6 log CFU/g
Standard Error 0.1
|
5.6 log CFU/g
Standard Error 0.1
|
6.4 log CFU/g
Standard Error 0.1
|
|
Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)
GI Viability of Bacillus Spores Week 6
|
1.6 log CFU/g
Standard Error 0.1
|
1.3 log CFU/g
Standard Error 0.2
|
0.8 log CFU/g
Standard Error 0.1
|
2.1 log CFU/g
Standard Error 0.1
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B. Subtilis R0179 (0.1 Billion CFU)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
B. Subtilis R0179 (1 Billion CFU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B. Subtilis R0179 (10 Billion CFU)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 participants at risk
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=22 participants at risk
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 participants at risk
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Hypotension
|
0.00%
0/20 • Data monitoring adverse events was collected over the study period.
|
4.8%
1/21 • Number of events 1 • Data monitoring adverse events was collected over the study period.
|
0.00%
0/22 • Data monitoring adverse events was collected over the study period.
|
0.00%
0/20 • Data monitoring adverse events was collected over the study period.
|
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.
Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (0.1 Billion CFU)
n=21 participants at risk
B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (1 Billion CFU)
n=22 participants at risk
B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
B. Subtilis R0179 (10 Billion CFU)
n=20 participants at risk
B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.
B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrheal Symptoms
|
0.00%
0/20 • Data monitoring adverse events was collected over the study period.
|
4.8%
1/21 • Number of events 1 • Data monitoring adverse events was collected over the study period.
|
0.00%
0/22 • Data monitoring adverse events was collected over the study period.
|
0.00%
0/20 • Data monitoring adverse events was collected over the study period.
|
|
Skin and subcutaneous tissue disorders
Itchiness and Redness Symptoms
|
0.00%
0/20 • Data monitoring adverse events was collected over the study period.
|
0.00%
0/21 • Data monitoring adverse events was collected over the study period.
|
0.00%
0/22 • Data monitoring adverse events was collected over the study period.
|
5.0%
1/20 • Number of events 1 • Data monitoring adverse events was collected over the study period.
|
Additional Information
Dr. Wendy Dahl
Department of Food Science and Human Nutrition, University of Florida
Phone: 352-392-1991
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place