Trial Outcomes & Findings for Probiotics for Quality of Life in Autism Spectrum Disorders (NCT NCT02903030)
NCT ID: NCT02903030
Last Updated: 2020-02-05
Results Overview
A 74-item survey with 14 scales. Report forms for specific age ranges assess the parent's perception of the child's GI function and/or symptoms during the last month on a 5-point scale from 0 (never a problem) to 4 (almost always a problem). Items are reverse-scored and transformed to a 0-100 scale so lower scores reflect worse GI dysfunction. Response choices are in Likert-scale format ranging from 0 to 4 (0=Never, 1=Almost Never, 2=Sometimes, 3=Often, 4=Almost Always).
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
13 participants
Primary outcome timeframe
Baseline and Week 8 of Both the First and Second Intervention
Results posted on
2020-02-05
Participant Flow
13 participants were screened and randomized to be in the study at the OSU Wexner Medical Center, Nisonger Center in 2016.
13 patients were randomized to order, but 3 dropped out because of distance and transportation without providing any follow-up data, leaving 10 who progressed through to study completion. (77% retention rate)
Participant milestones
| Measure |
Visbiome, Then Placebo
Children aged 3-12 years with ASD, GI symptoms, and anxiety were randomly assigned 1:1 to probiotic Visbiome for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment (19 weeks total).
The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.
Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
|
Placebo, Then Visbiome
Children aged 3-12 years with ASD, GI symptoms, and anxiety were randomly assigned 1:1 to placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment (19 weeks total).
Placebo matched to probiotic.
Maltose (placebo): Maltose with a trace amount of silicon dioxide
|
|---|---|---|
|
First Intervention (8 Weeks)
STARTED
|
8
|
5
|
|
First Intervention (8 Weeks)
Received Intervention
|
6
|
4
|
|
First Intervention (8 Weeks)
COMPLETED
|
6
|
4
|
|
First Intervention (8 Weeks)
NOT COMPLETED
|
2
|
1
|
|
Washout (3 Weeks)
STARTED
|
6
|
4
|
|
Washout (3 Weeks)
COMPLETED
|
6
|
4
|
|
Washout (3 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (8 Weeks)
STARTED
|
6
|
4
|
|
Second Intervention (8 Weeks)
COMPLETED
|
6
|
4
|
|
Second Intervention (8 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Visbiome, Then Placebo
Children aged 3-12 years with ASD, GI symptoms, and anxiety were randomly assigned 1:1 to probiotic Visbiome for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment (19 weeks total).
The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.
Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
|
Placebo, Then Visbiome
Children aged 3-12 years with ASD, GI symptoms, and anxiety were randomly assigned 1:1 to placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment (19 weeks total).
Placebo matched to probiotic.
Maltose (placebo): Maltose with a trace amount of silicon dioxide
|
|---|---|---|
|
First Intervention (8 Weeks)
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Probiotics for Quality of Life in Autism Spectrum Disorders
Baseline characteristics by cohort
| Measure |
Visbiome, Then Placebo
n=6 Participants
Participants were randomly assigned 1:1 to Visbiome probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose: the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.
Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
|
Placebo, the Visbiome
n=4 Participants
Particiapants were randomly assigned 1:1 to placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose: the first 4 weeks of the probiotic treatment was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
Placebo matched to probiotic.
Maltose (placebo): Maltose with a trace amount of silicon dioxide
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Gastrointestinal Module of the Pediatric Quality of Life Inventory (PedsQL)
|
66.73 units on a scale
STANDARD_DEVIATION 20.193 • n=5 Participants
|
59.60 units on a scale
STANDARD_DEVIATION 17.214 • n=7 Participants
|
63.17 units on a scale
STANDARD_DEVIATION 18.76 • n=5 Participants
|
|
Parent-Rated Anxiety Scale for ASD (PRAS-ASD)
|
40.00 units on a scale
STANDARD_DEVIATION 15.582 • n=5 Participants
|
41.25 units on a scale
STANDARD_DEVIATION 10.012 • n=7 Participants
|
40.63 units on a scale
STANDARD_DEVIATION 18.52 • n=5 Participants
|
|
Aberrant Behavior Checklist (ABC)
(1) irritability
|
18.50 units on a scale
STANDARD_DEVIATION 12.661 • n=5 Participants
|
25.00 units on a scale
STANDARD_DEVIATION 10.801 • n=7 Participants
|
21.75 units on a scale
STANDARD_DEVIATION 16.64 • n=5 Participants
|
|
Aberrant Behavior Checklist (ABC)
(2) lethargy
|
18.83 units on a scale
STANDARD_DEVIATION 12.336 • n=5 Participants
|
21.25 units on a scale
STANDARD_DEVIATION 13.598 • n=7 Participants
|
20.04 units on a scale
STANDARD_DEVIATION 18.35 • n=5 Participants
|
|
Aberrant Behavior Checklist (ABC)
(3) stereotypy
|
9.33 units on a scale
STANDARD_DEVIATION 4.803 • n=5 Participants
|
10.00 units on a scale
STANDARD_DEVIATION 8.287 • n=7 Participants
|
9.67 units on a scale
STANDARD_DEVIATION 9.57 • n=5 Participants
|
|
Aberrant Behavior Checklist (ABC)
(4) hyperactivity
|
22.67 units on a scale
STANDARD_DEVIATION 11.639 • n=5 Participants
|
35.00 units on a scale
STANDARD_DEVIATION 10.132 • n=7 Participants
|
28.83 units on a scale
STANDARD_DEVIATION 15.43 • n=5 Participants
|
|
Aberrant Behavior Checklist (ABC)
inappropriate speech
|
5.33 units on a scale
STANDARD_DEVIATION 3.327 • n=5 Participants
|
8.25 units on a scale
STANDARD_DEVIATION 4.500 • n=7 Participants
|
6.79 units on a scale
STANDARD_DEVIATION 5.60 • n=5 Participants
|
|
Social Responsiveness Scale (SRS)
|
82.17 units on a scale
STANDARD_DEVIATION 7.859 • n=5 Participants
|
87.00 units on a scale
STANDARD_DEVIATION 4.761 • n=7 Participants
|
84.585 units on a scale
STANDARD_DEVIATION 9.189 • n=5 Participants
|
|
Abbreviated Children's Sleep Habits Questionnaire (CSHQ)
|
43.50 units on a scale
STANDARD_DEVIATION 8.02 • n=5 Participants
|
59.75 units on a scale
STANDARD_DEVIATION 13.00 • n=7 Participants
|
51.63 units on a scale
STANDARD_DEVIATION 15.27 • n=5 Participants
|
|
Parenting Stress Index Short Form (PSI)
|
108.17 units on a scale
STANDARD_DEVIATION 20.731 • n=5 Participants
|
129.50 units on a scale
STANDARD_DEVIATION 17.767 • n=7 Participants
|
118.84 units on a scale
STANDARD_DEVIATION 27.303 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8 of Both the First and Second InterventionA 74-item survey with 14 scales. Report forms for specific age ranges assess the parent's perception of the child's GI function and/or symptoms during the last month on a 5-point scale from 0 (never a problem) to 4 (almost always a problem). Items are reverse-scored and transformed to a 0-100 scale so lower scores reflect worse GI dysfunction. Response choices are in Likert-scale format ranging from 0 to 4 (0=Never, 1=Almost Never, 2=Sometimes, 3=Often, 4=Almost Always).
Outcome measures
| Measure |
Visbiome
n=10 Participants
Randomly assigned 1:1 probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.
Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
|
Placebo
n=10 Participants
Randomly assigned 1:1 placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
Placebo matched to probiotic.
Maltose (placebo): Maltose with a trace amount of silicon dioxide
|
|---|---|---|
|
Change in Gastrointestinal (GI) Module of the Pediatric Quality of Life Inventory (PedsQL) at From Baseline at Week 8
|
17.97 Units on a scale
Standard Deviation 14.105
|
7.98 Units on a scale
Standard Deviation 11.247
|
SECONDARY outcome
Timeframe: Baseline and Week 8 of Both the First and Second InterventionParents are asked to name the 2 problems of most concern to them at baseline; a clinician helps the parent quantify and describe the problem (frequency, duration, severity, interference with daily life) at baseline. At subsequent visits the clinician reminds the parent of the previous description and helps them again quantify/describe the current state. A panel of blind clinicians reviews the descriptions and rates each on a 9-point scale relative to baseline, from remission (0) to disastrously worse (9), with 5=no change. These ratings are averaged, capturing the issues of most concern to parents across families. For purposes of this study, one of the 2 problems will be required to pertain to GI function, and will be analyzed separately as well as being averaged into the overall symptom rating.
Outcome measures
| Measure |
Visbiome
n=10 Participants
Randomly assigned 1:1 probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.
Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
|
Placebo
n=10 Participants
Randomly assigned 1:1 placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
Placebo matched to probiotic.
Maltose (placebo): Maltose with a trace amount of silicon dioxide
|
|---|---|---|
|
Change in Target Symptom Rating From Baseline at Week 8
|
-2.10 Units on a scale
Standard Deviation 1.647
|
-0.60 Units on a scale
Standard Deviation 1.370
|
SECONDARY outcome
Timeframe: Baseline and Week 8 of Both the First and Second InterventionA 25-item single-factor scale measure of emotional stability/anxiety. Higher scores are worse for PRAS-ASD subscale, hence a negative estimate means more improvement with the probiotics compared to control. Scores range from 0-75.
Outcome measures
| Measure |
Visbiome
n=10 Participants
Randomly assigned 1:1 probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.
Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
|
Placebo
n=10 Participants
Randomly assigned 1:1 placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
Placebo matched to probiotic.
Maltose (placebo): Maltose with a trace amount of silicon dioxide
|
|---|---|---|
|
Change in Parent Anxiety Checklist--ASD From Baseline at Week 8
|
-6.20 Units on a scale
Standard Deviation 10.830
|
-4.10 Units on a scale
Standard Deviation 11.259
|
SECONDARY outcome
Timeframe: Baseline and Week 8 of Both the First and Second InterventionThe ABC is a 58-item parent rating on a 0-3 scale with five subscales: * Irritability (includes agitation, aggression, and self-injury, 15 items) with range of scores from 0-45 * Social Withdrawal (16 items) with range of scores from 0-48 * Stereotypies (7 items) with range of scores from 0-21 * Hyperactivity (16 items) with range of scores from 0-48 * Inappropriate Speech (4 items) with range of scores from 0-12. Higher scores are worse for the ABC subscale, hence a negative estimate means more improvement with the probiotics compared to control.
Outcome measures
| Measure |
Visbiome
n=10 Participants
Randomly assigned 1:1 probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.
Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
|
Placebo
n=10 Participants
Randomly assigned 1:1 placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
Placebo matched to probiotic.
Maltose (placebo): Maltose with a trace amount of silicon dioxide
|
|---|---|---|
|
Change in The Aberrant Behavior Checklist (ABC) From Baseline at Week 8
ABC (4) Hyperactivity
|
-2.10 Units on a scale
Standard Deviation 6.385
|
-5.40 Units on a scale
Standard Deviation 6.851
|
|
Change in The Aberrant Behavior Checklist (ABC) From Baseline at Week 8
ABC (1) Irritability
|
-1.80 Units on a scale
Standard Deviation 5.245
|
-3.50 Units on a scale
Standard Deviation 5.622
|
|
Change in The Aberrant Behavior Checklist (ABC) From Baseline at Week 8
ABC (2) Lethargy
|
-2.60 Units on a scale
Standard Deviation 8.140
|
-2.50 Units on a scale
Standard Deviation 4.327
|
|
Change in The Aberrant Behavior Checklist (ABC) From Baseline at Week 8
ABC (3) Stereotypy
|
-1.20 Units on a scale
Standard Deviation 4.367
|
-1.80 Units on a scale
Standard Deviation 3.521
|
|
Change in The Aberrant Behavior Checklist (ABC) From Baseline at Week 8
ABC (5) Inappropriate Speech
|
-0.40 Units on a scale
Standard Deviation 2.011
|
-0.10 Units on a scale
Standard Deviation 1.370
|
SECONDARY outcome
Timeframe: Baseline and Week 8 of Both the First and Second InterventionThis 65-item rating scale measures the severity of autism spectrum symptoms as they occur in natural social settings. The SRS provides a clear picture of a child's social impairments, assessing social awareness, social information processing, capacity for reciprocal social communication, social anxiety/avoidance, and autistic preoccupations and traits. It is appropriate for use with children from 4 to 18 years of age and will detect changes in core ASD symptoms. A higher score in this scale represents worse symptoms with raw scores summed and generated t-scores ranging from 0-110.
Outcome measures
| Measure |
Visbiome
n=10 Participants
Randomly assigned 1:1 probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.
Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
|
Placebo
n=10 Participants
Randomly assigned 1:1 placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
Placebo matched to probiotic.
Maltose (placebo): Maltose with a trace amount of silicon dioxide
|
|---|---|---|
|
Change in Social Responsiveness Scale (SRS) From Baseline at Week 8
|
-4.70 Units on a scale
Standard Deviation 6.255
|
-1.70 Units on a scale
Standard Deviation 5.187
|
SECONDARY outcome
Timeframe: Week 8 of Both the First and Second InterventionIt includes 33 items rated retrospectively over the previous week by parents yielding a total score and eight subscales. Eight subscales include: (1) bedtime resistance (2) sleep onset latency, (3) sleep duration, (4) anxiety around sleep, (5) night awakenings, (6) sleep disordered breathing, (7) parasomnias and (8) morning waking/daytime sleepiness.Total score (summed) range of 0-99. A higher score is a better outcome for this measure.
Outcome measures
| Measure |
Visbiome
n=10 Participants
Randomly assigned 1:1 probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.
Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
|
Placebo
n=10 Participants
Randomly assigned 1:1 placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
Placebo matched to probiotic.
Maltose (placebo): Maltose with a trace amount of silicon dioxide
|
|---|---|---|
|
Children's Sleep Habits Questionnaire (CSHQ) at Week 8
|
42.80 Units on a scale
Standard Deviation 7.510
|
43.44 Units on a scale
Standard Deviation 7.502
|
SECONDARY outcome
Timeframe: Baseline and Week 8 of Both the First and Second InterventionThe PSI is used to evaluate the degree of stress in the parent-child relationship. The Short Form has 36 items from the full length PSI, rated on a 5-point scale from 1 = strongly disagree, to 5 = strongly agree. It is completed in 10-15 minutes. The PSI may be used for parents of children up to 12 years. It yields a Total Score and three domain scores. This will detect effect on parental stress and QOL. Higher scores (ranging from 0-180) are worse for PSI, hence a negative estimate means more improvement with the probiotics compared to control.
Outcome measures
| Measure |
Visbiome
n=10 Participants
Randomly assigned 1:1 probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.
Visbiome Extra Strength: It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
|
Placebo
n=10 Participants
Randomly assigned 1:1 placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
Placebo matched to probiotic.
Maltose (placebo): Maltose with a trace amount of silicon dioxide
|
|---|---|---|
|
Change in The Parenting Stress Index Short Form (PSI)
|
-9.60 Units on a scale
Standard Deviation 16.675
|
-1.70 Units on a scale
Standard Deviation 5.187
|
Adverse Events
Visbiome
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Visbiome
n=10 participants at risk
Randomly assigned 1:1 probiotic for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
The probiotic mix (VISBIOME) will be mainly Bifidobacteria and Lactobacilli, in view of the previously reported encouraging clinical studies and safety data.
Visbiome Extra Strength: A mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
|
Placebo
n=10 participants at risk
Randomly assigned 1:1 placebo for 8 weeks, followed by a 3-week washout and an 8 week crossover treatment. (19 weeks total) Starting dose, the first 4 weeks, was a half packet twice daily mixed with food. At 4 week and 15-week visit, there was an option to increase to a full packet twice daily if no effect was noted.
Placebo matched to probiotic.
Maltose (placebo): Maltose with a trace amount of silicon dioxide
|
|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
60.0%
6/10 • Number of events 7 • After Baseline: 4 weeks, 8 weeks, 15 weeks, 19 weeks
Collected AE data from all participants of the study.
|
40.0%
4/10 • Number of events 9 • After Baseline: 4 weeks, 8 weeks, 15 weeks, 19 weeks
Collected AE data from all participants of the study.
|
Additional Information
Dr. L. Eugene Arnold, MD, MED. Professor Emeritus College of Medicine
Nisonger Center
Phone: 614-685-6701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place