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NCT06321796 · ClinicalTrials.gov registry record · Phase 2
Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders
A Phase 2 study of Pitt Hopkins Syndrome, sponsored by Gut-Brain-Axis Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06321796: Recruiting Phase 2 study of Pitt Hopkins Syndrome, sponsored by Gut-Brain-Axis Therapeutics.
NCT06321796 is a Phase 2 study of Pitt Hopkins Syndrome that is actively recruiting participants, run by Gut-Brain-Axis Therapeutics. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06321796, a Phase 2 study of Pitt Hopkins Syndrome, is actively recruiting participants, sponsored by Gut-Brain-Axis Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Pitt-Hopkins Syndrome (PTHS) and gastrointestinal problems (constipation, bloating, abdominal pain). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacteria), followed by 1 day of bowel cleanse using magnesium citrate, followed by 4 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 Magnesium Citrate
- COMBINATION_PRODUCT Antacid
- COMBINATION_PRODUCT Placebo MTP-101P
Study Locations (1)
Arizona
- Autism/Asperger's Research Group at Arizona State University - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-02-27 |
| Est. Completion | 2025-05 |
| Phase | Phase 2 |
What NCT06321796 shows while recruiting
NCT06321796 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Pitt Hopkins Syndrome appearing as the primary indexed condition, and to 5 interventions - of which MTP-101P is the first listed.
NCT06321796 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT06321796 about?
NCT06321796 is a clinical study titled "Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders". The investigators propose to investigate Microbiota Transfer Therapy (MTT) for treating patients with Pitt-Hopkins Syndrome (PTHS) and gastrointestinal problems (constipation, bloating, abdominal pain). MTT involves a combination of 10 days of oral vancomycin (an antibiotic to kill pathogenic bacter...
What is the current status of trial NCT06321796?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-02-27. Estimated completion is 2025-05.
What conditions does trial NCT06321796 study?
This clinical trial studies the following conditions: Pitt Hopkins Syndrome.
What interventions are being tested in trial NCT06321796?
The interventions under investigation include: MTP-101P (COMBINATION_PRODUCT), Vancomycin (COMBINATION_PRODUCT), Magnesium Citrate (COMBINATION_PRODUCT), Antacid (COMBINATION_PRODUCT), Placebo MTP-101P (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06321796?
This trial is sponsored by Gut-Brain-Axis Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06321796 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 Pitt Hopkins Syndrome
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 NCT06321796's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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