drugset / Trial / NCT06321796
Microbiota Transfer Therapy for Children and Adults With Both Pitt Hopkins Syndrome and Gastrointestinal Disorders
Phase 2
Unknown
20 enrolled
Gut-Brain-Axis Therapeutics Inc.
Pitt Hopkins Research Foundation · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-02-27
- Primary completion
- 2025-02
- Completion
- 2025-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MTP-101P | Other / unclassified | — | — |
| Subject | Vancomycin | Other / unclassified | — | Oral |
| Background | Aluminum hydroxide | Unknown | 200 mg | — |
| Background | Calcium carbonate | Other / unclassified | — | — |
| Background | Magnesium Citrate | Unknown | — | — |
| Background | Simethicone | Other / unclassified | 20 mg | — |
| Background | magnesium hydroxide | Unknown | 200 mg | — |