An interventional study of Flore in Autism Spectrum Disorder, sponsored by Arizona State University. Completed at 1 site in United States. Open to participants aged 30 Months to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by Arizona State University · Not applicable, Interventional, and Treatment
This is a study of the effect of a customized probiotic on children and adults with autism, including effects on autism symptoms and gastrointestinal symptoms.
SunGenomics provides its customers with a customized probiotic based on an analysis of the microbiota in their stool samples. Customers who have autism spectrum disorders are invited to participate in this study by completing several questionnaires about their medical history, diet, autism symptoms, and gastrointestinal symptoms before taking the probiotic, and to repeat those questionnaires approximately 3 months later. This is effectively an open-label study.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 296 is above the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Arizona State University is the lead sponsor of 234 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each participant receives a customized probiotic based on the results of the test of their microbiota
Dietary Supplement: Flore
personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals
Parent Global Impressions of Autism - Change
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).
Time frame: change in score between baseline and 3 months
Social Responsiveness Scale
A questionnaire about social skills, where higher scores suggest more severe autism. Scores range from 0 to 195, with higher scores indicating more severe problems.
Time frame: change in score between baseline and 3 months
Gastrointestinal Symptom Rating Scale
A 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
Time frame: change in score between baseline and 3 months
| Milestone | Treatment Group |
|---|---|
| Started | 296 |
| Completed | 170 |
| Not completed | 126 |
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).
| score on a scale | Treatment Group |
|---|---|
| Parent Global Impressions of Autism - Change | 0.36 ± 0.55 |
A questionnaire about social skills, where higher scores suggest more severe autism. Scores range from 0 to 195, with higher scores indicating more severe problems.
| score on a scale | Treatment Group |
|---|---|
| Baseline | 80.2 ± 9.3 |
| End of treatment | 78.6 ± 8.7 |
A 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
| score on a scale | Treatment Group |
|---|---|
| Baseline | 2.25 ± 0.98 |
| End of treatment | 1.96 ± 0.95 |
Collected over During the 3 months of synbiotic treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | 0/296 (0%) | 0/296 (0%) | 1/296 (0.3%) |
| Event | Treatment Group |
|---|---|
| gut symptoms, autism symptoms and behaviorGeneral disorders | 1/296 |
| Age, Continuous(years) | Treatment Group |
|---|---|
| Mean | 10.4 ± 7.1 |
| Sex: Female, Male(Participants) | Treatment Group |
|---|---|
| Female | 60 |
| Male | 236 |
| Race and Ethnicity Not Collected(Participants) | Treatment Group |
|---|
| Region of Enrollment(participants) | Treatment Group |
|---|---|
| United States | 296 |
| Parent Global Impressions of Autism (PGIA) - Baseline(units on a scale) | Treatment Group |
|---|---|
| Mean | 2.81 ± 0.87 |
| Social Responsiveness Scale (SRS-2)(units on a scale) | Treatment Group |
|---|---|
| Mean | 80.1 ± 10.4 |
| Gastrointestinal Symptom Rating Scale (GSRS)(units on a scale) | Treatment Group |
|---|---|
| Mean | 2.25 ± 0.97 |
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Arizona State University