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NCT04655326 · ClinicalTrials.gov registry record · NA
Probiotic Therapy for Children and Adults With Autism Spectrum Disorder
A NA study, sponsored by Arizona State University.
- Completed
- Registry status
- NA
- Development phase
- 296
- Enrollment target
NCT04655326: Completed NA study, sponsored by Arizona State University.
NCT04655326 is a NA study that has completed, run by Arizona State University. The registered enrollment target is 296 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04655326, a NA study, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 296 participants
- Enrollment target
Study 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.
Primary Outcome
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 P
Interventions
- DIETARY_SUPPLEMENT Flore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2020-10-15 |
| Est. Completion | 2025-07-12 |
| Phase | NA |
What the finished NCT04655326 record still lists
NCT04655326 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Flore is the first listed.
NCT04655326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04655326 about?
NCT04655326 is a clinical study titled "Probiotic Therapy for Children and Adults With Autism Spectrum Disorder". 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.
What is the current status of trial NCT04655326?
This trial is currently completed. It is a NA study. The enrollment target is 296 participants. The study started on 2020-10-15. Estimated completion is 2025-07-12.
What interventions are being tested in trial NCT04655326?
The interventions under investigation include: Flore (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04655326?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04655326's enrollment target sits among peer trials
296 373rd of 2000 higher than 1,628 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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