Trial Outcomes & Findings for Efficacy and Safety of BB-12 Supplemented Strawberry Yogurt For Healthy Children on Antibiotics (NCT NCT03181516)
NCT ID: NCT03181516
Last Updated: 2025-02-21
Results Overview
Diarrhea is clinically defined as three or more loose stools per day for two consecutive days. This will be a dichotomous (yes or no) outcome of diarrhea.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
255 participants
Primary outcome timeframe
14 days
Results posted on
2025-02-21
Participant Flow
Participant milestones
| Measure |
BB-12
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Bifidobacterium animalis subsp. lactis BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
Control
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12
|
|---|---|---|
|
Overall Study
STARTED
|
125
|
130
|
|
Overall Study
COMPLETED
|
109
|
121
|
|
Overall Study
NOT COMPLETED
|
16
|
9
|
Reasons for withdrawal
| Measure |
BB-12
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Bifidobacterium animalis subsp. lactis BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
Control
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
7
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Some participants did not fill out their birthday so their age was not known. However, it was confirmed that they were between the ages of 3-12 years old when enrolling.
Baseline characteristics by cohort
| Measure |
BB-12
n=125 Participants
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Bifidobacterium animalis subsp. lactis BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
Control
n=130 Participants
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.97 years
STANDARD_DEVIATION 2.71 • n=110 Participants • Some participants did not fill out their birthday so their age was not known. However, it was confirmed that they were between the ages of 3-12 years old when enrolling.
|
6.44 years
STANDARD_DEVIATION 2.87 • n=113 Participants • Some participants did not fill out their birthday so their age was not known. However, it was confirmed that they were between the ages of 3-12 years old when enrolling.
|
6.70 years
STANDARD_DEVIATION 2.80 • n=223 Participants • Some participants did not fill out their birthday so their age was not known. However, it was confirmed that they were between the ages of 3-12 years old when enrolling.
|
|
Sex: Female, Male
Female
|
53 Participants
n=118 Participants • There were certain participants who did not answer the question regarding sex, so their sex was unknown causing the number of participants to differ.
|
64 Participants
n=126 Participants • There were certain participants who did not answer the question regarding sex, so their sex was unknown causing the number of participants to differ.
|
117 Participants
n=244 Participants • There were certain participants who did not answer the question regarding sex, so their sex was unknown causing the number of participants to differ.
|
|
Sex: Female, Male
Male
|
65 Participants
n=118 Participants • There were certain participants who did not answer the question regarding sex, so their sex was unknown causing the number of participants to differ.
|
62 Participants
n=126 Participants • There were certain participants who did not answer the question regarding sex, so their sex was unknown causing the number of participants to differ.
|
127 Participants
n=244 Participants • There were certain participants who did not answer the question regarding sex, so their sex was unknown causing the number of participants to differ.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
58 Participants
n=125 Participants
|
58 Participants
n=130 Participants
|
116 Participants
n=255 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=125 Participants
|
68 Participants
n=130 Participants
|
129 Participants
n=255 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=125 Participants
|
4 Participants
n=130 Participants
|
10 Participants
n=255 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=125 Participants
|
1 Participants
n=130 Participants
|
1 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=125 Participants
|
4 Participants
n=130 Participants
|
8 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=125 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=125 Participants
|
3 Participants
n=130 Participants
|
5 Participants
n=255 Participants
|
|
Race (NIH/OMB)
White
|
77 Participants
n=125 Participants
|
82 Participants
n=130 Participants
|
159 Participants
n=255 Participants
|
|
Race (NIH/OMB)
More than one race
|
19 Participants
n=125 Participants
|
17 Participants
n=130 Participants
|
36 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=125 Participants
|
23 Participants
n=130 Participants
|
46 Participants
n=255 Participants
|
|
Region of Enrollment
United States
|
125 participants
n=125 Participants
|
130 participants
n=130 Participants
|
255 participants
n=255 Participants
|
|
Health Insurance Status
Yes
|
110 participants
n=125 Participants
|
123 participants
n=130 Participants
|
233 participants
n=255 Participants
|
|
Health Insurance Status
No
|
10 participants
n=125 Participants
|
4 participants
n=130 Participants
|
14 participants
n=255 Participants
|
|
Health Insurance Status
Unknown
|
5 participants
n=125 Participants
|
3 participants
n=130 Participants
|
8 participants
n=255 Participants
|
|
Smoking in the Household
Yes
|
7 Participants
n=125 Participants
|
2 Participants
n=130 Participants
|
9 Participants
n=255 Participants
|
|
Smoking in the Household
No
|
112 Participants
n=125 Participants
|
125 Participants
n=130 Participants
|
237 Participants
n=255 Participants
|
|
Smoking in the Household
Unknown
|
6 Participants
n=125 Participants
|
3 Participants
n=130 Participants
|
9 Participants
n=255 Participants
|
|
Marital Status of Accompanying Guardian
Single
|
16 Participants
n=125 Participants
|
12 Participants
n=130 Participants
|
28 Participants
n=255 Participants
|
|
Marital Status of Accompanying Guardian
Married
|
82 Participants
n=125 Participants
|
92 Participants
n=130 Participants
|
174 Participants
n=255 Participants
|
|
Marital Status of Accompanying Guardian
Living with a Partner
|
13 Participants
n=125 Participants
|
6 Participants
n=130 Participants
|
19 Participants
n=255 Participants
|
|
Marital Status of Accompanying Guardian
Divorced
|
4 Participants
n=125 Participants
|
2 Participants
n=130 Participants
|
6 Participants
n=255 Participants
|
|
Marital Status of Accompanying Guardian
Separated
|
2 Participants
n=125 Participants
|
5 Participants
n=130 Participants
|
7 Participants
n=255 Participants
|
|
Marital Status of Accompanying Guardian
Widowed
|
0 Participants
n=125 Participants
|
1 Participants
n=130 Participants
|
1 Participants
n=255 Participants
|
|
Marital Status of Accompanying Guardian
Not reported/Unknown
|
8 Participants
n=125 Participants
|
12 Participants
n=130 Participants
|
20 Participants
n=255 Participants
|
|
total annual income of all the family members living in the household before taxes
< $15,000
|
7 Participants
n=125 Participants
|
6 Participants
n=130 Participants
|
13 Participants
n=255 Participants
|
|
total annual income of all the family members living in the household before taxes
$15,000 - $30,000
|
18 Participants
n=125 Participants
|
8 Participants
n=130 Participants
|
26 Participants
n=255 Participants
|
|
total annual income of all the family members living in the household before taxes
$30,001 - $50,000
|
10 Participants
n=125 Participants
|
8 Participants
n=130 Participants
|
18 Participants
n=255 Participants
|
|
total annual income of all the family members living in the household before taxes
$50,001 - $75,000
|
5 Participants
n=125 Participants
|
7 Participants
n=130 Participants
|
12 Participants
n=255 Participants
|
|
total annual income of all the family members living in the household before taxes
$75,001 - $100,000
|
4 Participants
n=125 Participants
|
5 Participants
n=130 Participants
|
9 Participants
n=255 Participants
|
|
total annual income of all the family members living in the household before taxes
$100,001 - $150,000
|
17 Participants
n=125 Participants
|
15 Participants
n=130 Participants
|
32 Participants
n=255 Participants
|
|
total annual income of all the family members living in the household before taxes
$150,001 - $200,000
|
10 Participants
n=125 Participants
|
15 Participants
n=130 Participants
|
25 Participants
n=255 Participants
|
|
total annual income of all the family members living in the household before taxes
> $200,000
|
29 Participants
n=125 Participants
|
29 Participants
n=130 Participants
|
58 Participants
n=255 Participants
|
|
total annual income of all the family members living in the household before taxes
Prefer not to answer/Unknown
|
25 Participants
n=125 Participants
|
37 Participants
n=130 Participants
|
62 Participants
n=255 Participants
|
PRIMARY outcome
Timeframe: 14 daysDiarrhea is clinically defined as three or more loose stools per day for two consecutive days. This will be a dichotomous (yes or no) outcome of diarrhea.
Outcome measures
| Measure |
BB-12
n=125 Participants
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Bifidobacterium animalis subsp. lactis BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
Control
n=130 Participants
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12
|
|---|---|---|
|
Number of Participants Experiencing Diarrhea
Yes
|
3 Participants
|
2 Participants
|
|
Number of Participants Experiencing Diarrhea
No
|
122 Participants
|
128 Participants
|
PRIMARY outcome
Timeframe: Days 0-180Number of reported adverse events over the duration of the study
Outcome measures
| Measure |
BB-12
n=125 Participants
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Bifidobacterium animalis subsp. lactis BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
Control
n=130 Participants
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12
|
|---|---|---|
|
Adverse Events
|
144 AE events
|
148 AE events
|
SECONDARY outcome
Timeframe: 7 daysPopulation: Some participants did not fill out the PEDSQL Day 7 form.
The PedsQL Measurement Measurement Model for the Pediatric Quality-of-Life Inventory. Based on the PedsQL form filled out by participants, the scores were translated using the PedsQL form guidelines: 0=100, 1=75, 2=50,3=25,4=0. The raw scores of participants were averaged after translation. The lowest possible score is 0 and the highest possible score is 100. A higher score indicates a healthier lifestyle.
Outcome measures
| Measure |
BB-12
n=63 Participants
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Bifidobacterium animalis subsp. lactis BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
Control
n=69 Participants
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12
|
|---|---|---|
|
Pediatric Quality-of-life Score
|
85 score on a scale
Standard Deviation 19
|
91 score on a scale
Standard Deviation 10
|
SECONDARY outcome
Timeframe: 14 daysThis will be a dichotomous (yes or no) outcome of loose stools, constipation, fever, flatulence, lack of appetite, pain, rash, vomiting, cough, earache, nasal congestion, runny nose, sore throat.
Outcome measures
| Measure |
BB-12
n=125 Participants
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Bifidobacterium animalis subsp. lactis BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
Control
n=130 Participants
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12
|
|---|---|---|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Loose stools
|
25 Events
|
19 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Constipation
|
15 Events
|
21 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Pain
|
16 Events
|
14 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Nasal Congestion
|
14 Events
|
12 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Fever
|
11 Events
|
14 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Flatulence
|
6 Events
|
4 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Lack of Appetite
|
8 Events
|
10 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Rash
|
4 Events
|
10 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Vomiting
|
8 Events
|
2 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Cough
|
13 Events
|
17 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Earache
|
6 Events
|
1 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Runny nose
|
10 Events
|
9 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Sore throat
|
5 Events
|
13 Events
|
|
Number of Events: Symptoms of Loose Stools, Constipation, Fever, Flatulence, Lack of Appetite, Pain, Rash, Vomiting, Cough, Earache, Nasal Congestion, Runny Nose, Sore Throat, Diarrhea.
Diarrhea
|
3 Events
|
2 Events
|
Adverse Events
BB-12
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 69 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BB-12
n=125 participants at risk
Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
Bifidobacterium animalis subsp. lactis BB-12: Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
|
Control
n=130 participants at risk
Yogurt without Bifidobacterium animalis subsp. lactis BB-12
Control: Yogurt without Bifidobacterium animalis subsp. lactis BB-12
|
|---|---|---|
|
Gastrointestinal disorders
Loose Stools
|
19.2%
24/125 • Number of events 25 • 180 Days
|
13.1%
17/130 • Number of events 19 • 180 Days
|
|
Gastrointestinal disorders
Constipation
|
10.4%
13/125 • Number of events 15 • 180 Days
|
13.8%
18/130 • Number of events 21 • 180 Days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.6%
12/125 • Number of events 13 • 180 Days
|
12.3%
16/130 • Number of events 17 • 180 Days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
10.4%
13/125 • Number of events 14 • 180 Days
|
9.2%
12/130 • Number of events 12 • 180 Days
|
|
Respiratory, thoracic and mediastinal disorders
Fever
|
8.0%
10/125 • Number of events 11 • 180 Days
|
9.2%
12/130 • Number of events 14 • 180 Days
|
|
General disorders
Pain
|
12.8%
16/125 • Number of events 16 • 180 Days
|
10.8%
14/130 • Number of events 14 • 180 Days
|
|
Respiratory, thoracic and mediastinal disorders
Runny Nose
|
8.0%
10/125 • Number of events 10 • 180 Days
|
6.9%
9/130 • Number of events 9 • 180 Days
|
|
Gastrointestinal disorders
Lack of Appetite
|
5.6%
7/125 • Number of events 8 • 180 Days
|
7.7%
10/130 • Number of events 10 • 180 Days
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
4.0%
5/125 • Number of events 5 • 180 Days
|
8.5%
11/130 • Number of events 13 • 180 Days
|
|
General disorders
Rash
|
3.2%
4/125 • Number of events 4 • 180 Days
|
6.9%
9/130 • Number of events 10 • 180 Days
|
|
Gastrointestinal disorders
Flatulence
|
4.8%
6/125 • Number of events 6 • 180 Days
|
2.3%
3/130 • Number of events 4 • 180 Days
|
|
General disorders
Vomiting
|
6.4%
8/125 • Number of events 8 • 180 Days
|
1.5%
2/130 • Number of events 2 • 180 Days
|
|
Respiratory, thoracic and mediastinal disorders
Earache
|
4.8%
6/125 • Number of events 6 • 180 Days
|
0.77%
1/130 • Number of events 1 • 180 Days
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
3/125 • Number of events 3 • 180 Days
|
1.5%
2/130 • Number of events 2 • 180 Days
|
Additional Information
Dr. Daniel Merenstein
Georgetown University Medical Center
Phone: 2026872745
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place