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NCT03408886 · ClinicalTrials.gov registry record · Phase 2
Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders
A Phase 2 study of Autism Spectrum Disorder and Gastro-Intestinal Disorder, sponsored by Arizona State University.
- Active
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT03408886: Active Phase 2 study of Autism Spectrum Disorder and Gastro-Intestinal Disorder, sponsored by Arizona State University.
NCT03408886 is a Phase 2 study of Autism Spectrum Disorder and Gastro-Intestinal Disorder that is active but no longer recruiting, run by Arizona State University. The registered enrollment target is 55 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (59% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03408886, a Phase 2 study of Autism Spectrum Disorder and Gastro-Intestinal Disorder, is active but no longer recruiting, sponsored by Arizona State University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a clinical trial of Microbiota Transplant Therapy (MTT) for adults with autism spectrum disorders (ASD) who have gastrointestinal problems. Previous research has shown that individuals with ASD have a low diversity of gut bacteria, and low diversity is generally associated with poor gastrointestinal (GI) health. We previously found that MTT therapy for children with ASD and GI symptoms was helpful in reducing their GI symptoms, reducing their ASD symptoms, and increasing their diversity of gut bacteria. This clinical trial will investigate the hypothesis that MTT therapy will be helpful for adults with ASD who have GI symptoms.
Primary Outcome
An evaluation by a trained evaluator of autism symptoms. The range is 15-60, and scores in the range of 27-30 or higher are indicative of autism.
Conditions Studied
Interventions
- DRUG Vancomycin
- DRUG MoviPrep
- BIOLOGICAL Full Spectrum Microbiota
Study Locations (1)
Arizona
- Arizona State University - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-01-04 |
| Est. Completion | 2024-12-15 |
| Phase | Phase 2 |
What the registry record for NCT03408886 still lists
NCT03408886 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (59% lower).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 3 interventions - of which Vancomycin is the first listed.
NCT03408886 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03408886 about?
NCT03408886 is a clinical study titled "Microbiota Transfer Therapy for Adults With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders". This is a clinical trial of Microbiota Transplant Therapy (MTT) for adults with autism spectrum disorders (ASD) who have gastrointestinal problems. Previous research has shown that individuals with ASD have a low diversity of gut bacteria, and low diversity is generally associated with poor gastroi...
What is the current status of trial NCT03408886?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2018-01-04. Estimated completion is 2024-12-15.
What conditions does trial NCT03408886 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Gastro-Intestinal Disorder.
What interventions are being tested in trial NCT03408886?
The interventions under investigation include: Vancomycin (DRUG), MoviPrep (DRUG), Full Spectrum Microbiota (BIOLOGICAL).
Who is sponsoring clinical trial NCT03408886?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03408886 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03408886's enrollment target sits among peer trials
55 137th of 224 higher than 87 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder 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.
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