N/A
N=296
Probiotic Therapy for Children and Adults With Autism Spectrum Disorder
Autism Spectrum Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04655326 ↗Enrolled (actual)
296
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Parent Global Impressions of Autism - Change — 0.36 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Flore (Dietary_supplement)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Arizona State University
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Parent Global Impressions of Autism - Change |
0.36 | — |
| SECONDARY Social Responsiveness Scale |
80.2; 78.6 | >0.05 |
| SECONDARY Gastrointestinal Symptom Rating Scale |
2.25; 1.96 | <0.05 sig |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- New client of Sun Genomics (has applied for testing and treatment, but not yet begun treatment)
- Diagnosis of ASD (initially based on self-report of ASD diagnosis by appropriate medical professional, and then verified by an evaluation of the Social Responsiveness Scale (SRS-2) by ASU staff.
- Children and adults ages 2.5-75 years
Exclusion Criteria
- Antibiotic use in the last two months (not counting topical antibiotics)
- Any changes in medications, nutritional supplements, therapies, in the last two months, or any plans to change them during the first 3 months of probiotic treatment.
Data sourced from ClinicalTrials.gov (NCT04655326). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.