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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 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. The trial reports 1 study location across 1 state.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06321796
The ClinicalTrials.gov registry entry for NCT06321796 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gut-Brain-Axis Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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