Trial Outcomes & Findings for Probiotic Therapy for Children and Adults With Autism Spectrum Disorder (NCT NCT04655326)
NCT ID: NCT04655326
Last Updated: 2026-04-09
Results Overview
The PGIA-Change assesses the change in 20 different autism-related symptoms on a 7-point scale, from -3 (much worse) to 0 (no change) to +3 (much better) Note that this is a different scale than the PGIA-Baseline, which assesses severity on an absolute scale. The rationale for the two scales is that, based on our clinical experience, it appears that parents can give an approximate value for their child's severity (PGIA-Baseline), but that it is more accurate to ask them about change (with the PGIA-Change) than to ask them about severity again and compare it vs a baseline score (PGIA-Baseline).
COMPLETED
NA
296 participants
change in score between baseline and 3 months
2026-04-09
Participant Flow
Participant milestones
| Measure |
Treatment Group
Each participant receives a customized probiotic based on the results of the test of their microbiota
Flore: personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals
|
|---|---|
|
Overall Study
STARTED
|
296
|
|
Overall Study
COMPLETED
|
170
|
|
Overall Study
NOT COMPLETED
|
126
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment Group
n=296 Participants
Each participant receives a customized probiotic based on the results of the test of their microbiota
Flore: personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals
|
|---|---|
|
Age, Continuous
|
10.4 years
STANDARD_DEVIATION 7.1 • n=296 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=296 Participants
|
|
Sex: Female, Male
Male
|
236 Participants
n=296 Participants
|
|
Region of Enrollment
United States
|
296 participants
n=296 Participants
|
|
Parent Global Impressions of Autism (PGIA) - Baseline
|
2.81 units on a scale
STANDARD_DEVIATION 0.87 • n=296 Participants
|
|
Social Responsiveness Scale (SRS-2)
|
80.1 units on a scale
STANDARD_DEVIATION 10.4 • n=296 Participants
|
|
Gastrointestinal Symptom Rating Scale (GSRS)
|
2.25 units on a scale
STANDARD_DEVIATION 0.97 • n=296 Participants
|
PRIMARY outcome
Timeframe: change in score between baseline and 3 monthsThe PGIA-Change assesses the change in 20 different autism-related symptoms on a 7-point scale, from -3 (much worse) to 0 (no change) to +3 (much better) Note that this is a different scale than the PGIA-Baseline, which assesses severity on an absolute scale. The rationale for the two scales is that, based on our clinical experience, it appears that parents can give an approximate value for their child's severity (PGIA-Baseline), but that it is more accurate to ask them about change (with the PGIA-Change) than to ask them about severity again and compare it vs a baseline score (PGIA-Baseline).
Outcome measures
| Measure |
Treatment Group
n=170 Participants
Each participant receives a customized probiotic based on the results of the test of their microbiota
Flore: personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals
|
|---|---|
|
Parent Global Impressions of Autism - Change
|
0.36 score on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: change in score between baseline and 3 monthsA questionnaire about social skills, where higher scores suggest more severe autism. Scores range from 0 to 195, with higher scores indicating more severe problems.
Outcome measures
| Measure |
Treatment Group
n=170 Participants
Each participant receives a customized probiotic based on the results of the test of their microbiota
Flore: personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals
|
|---|---|
|
Social Responsiveness Scale
Baseline
|
80.2 score on a scale
Standard Deviation 9.3
|
|
Social Responsiveness Scale
End of treatment
|
78.6 score on a scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: change in score between baseline and 3 monthsA questionnaire which evaluates 15 gastrointestinal symptoms on a severity scale from 1 (none) to 7 (severe). We report the average score of those 15 items
Outcome measures
| Measure |
Treatment Group
n=170 Participants
Each participant receives a customized probiotic based on the results of the test of their microbiota
Flore: personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals
|
|---|---|
|
Gastrointestinal Symptom Rating Scale
Baseline
|
2.25 score on a scale
Standard Deviation 0.98
|
|
Gastrointestinal Symptom Rating Scale
End of treatment
|
1.96 score on a scale
Standard Deviation 0.95
|
Adverse Events
Treatment Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=296 participants at risk
Each participant receives a customized probiotic based on the results of the test of their microbiota
Flore: personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals
|
|---|---|
|
General disorders
gut symptoms, autism symptoms and behavior
|
0.34%
1/296 • Number of events 1 • During the 3 months of synbiotic treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place