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NCT06503978 · ClinicalTrials.gov registry record · Phase 2
Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders
A Phase 2 study of Autism Spectrum Disorder and Constipation, sponsored by Gut-Brain-Axis Therapeutics.
- Active
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06503978: Active Phase 2 study of Autism Spectrum Disorder and Constipation, sponsored by Gut-Brain-Axis Therapeutics.
NCT06503978 is a Phase 2 study of Autism Spectrum Disorder and Constipation that is active but no longer recruiting, run by Gut-Brain-Axis Therapeutics. The registered enrollment target is 60 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06503978, a Phase 2 study of Autism Spectrum Disorder and Constipation, is active but no longer recruiting, sponsored by Gut-Brain-Axis Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Autism-spectrum disorder with Gastrointestinal disorders (constipation, diarrhea, and/or abdominal pain). MTT involves a combination of 14 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by 1 day of bowel cleanse using Miralax, followed by 5 days of high dose MTP-101P with an antacid, followed by 12 weeks of a lower maintenance dose of MTP-101P with an antacid.
Primary Outcome
A 15-item scale that can be used to both diagnose autism and ASD and to assess the overall severity of symptoms
Conditions Studied
Interventions
- COMBINATION_PRODUCT MTP-101P
- COMBINATION_PRODUCT Vancomycin
- COMBINATION_PRODUCT Antacid
- COMBINATION_PRODUCT Placebo MTP-101P
- COMBINATION_PRODUCT Miralax
Study Locations (1)
Arizona
- Autism/Asperger's Research Group at Arizona State University - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-08-20 |
| Est. Completion | 2026-08-17 |
| Phase | Phase 2 |
What the registry record for NCT06503978 still lists
NCT06503978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (56% lower).
The record links to 4 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 5 interventions - of which MTP-101P is the first listed.
NCT06503978 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT06503978 about?
NCT06503978 is a clinical study titled "Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders". The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Autism-spectrum disorder with Gastrointestinal disorders (constipation, diarrhea, and/or abdominal pain). MTT involves a combination of 14 days of oral vancomycin (an antibiotic to kill pathogenic b...
What is the current status of trial NCT06503978?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-08-20. Estimated completion is 2026-08-17.
What conditions does trial NCT06503978 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Constipation, Diarrhea, Gastro-Intestinal Disorder.
What interventions are being tested in trial NCT06503978?
The interventions under investigation include: MTP-101P (COMBINATION_PRODUCT), Vancomycin (COMBINATION_PRODUCT), Antacid (COMBINATION_PRODUCT), Placebo MTP-101P (COMBINATION_PRODUCT), Miralax (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06503978?
This trial is sponsored by Gut-Brain-Axis Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06503978 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 NCT06503978's enrollment target sits among peer trials
60 118th of 224 higher than 95 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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