drugset / Trial / NCT06503978
Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-08-20
- Primary completion
- 2025-07-17
- Completion
- 2026-08-17
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 | Simethicone | Other / unclassified | 20 mg | — |
| Background | magnesium hydroxide | Unknown | 200 mg | — |
| Background | polyethylene glycol | Other / unclassified | — | — |