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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06503978
The ClinicalTrials.gov registry entry for NCT06503978 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (56% lower). The listed sponsor is Gut-Brain-Axis Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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