Microbiota Transfer Therapy for Autism and Gastrointestinal Disorders

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Gut-Brain-Axis Therapeutics Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

This trial is for children with Autism Spectrum Disorder who also have gastrointestinal issues like constipation, diarrhea, or abdominal pain. Participants must meet specific criteria that the study outlines.

Inclusion Criteria

I haven't changed my medications, supplements, diet, or therapies in the last 2 months.

I am in good health except for issues with my digestive system.

My child, aged 4-17, is diagnosed with autism.

Exclusion Criteria

I have not taken any antibiotics in the last 3 months, except for creams or ointments.

I have had recent surgery or have certain stomach or intestine conditions.

Current participation in other clinical trials

Treatment Details

Interventions

• Microbiota Transplant Therapy (Microbiota Therapy)

Trial Overview The study tests Microbiota Transfer Therapy (MTT), which includes a 14-day vancomycin course to remove harmful bacteria, a day of bowel cleanse with Miralax, then high dose MTP-101P with an antacid for five days followed by a maintenance dose for 12 weeks.

Participant Groups

Group I: Group B: Treatment (Dose 2) Experimental Treatment 4 Interventions

Part 1: Blinded Treatment (15 weeks) Vancomycin, Miralax, Antacid, MTP-101P

Group II: Group A: Treatment (Dose 1) Experimental Treatment 4 Interventions

Part 1: Blinded Treatment (15 weeks) Vancomycin, Miralax, Antacid, MTP-101P

Group III: Group D: Placebo Placebo Group 3 Interventions

Part 1: Blinded Placebo (15 weeks) Placebo Vancomycin, Real Miralax, Real Antacid, Placebo MTP-101P

Group IV: Group C: Placebo Placebo Group 3 Interventions

Part 1: Blinded Placebo (15 weeks) Placebo Vancomycin, Real Miralax, Real Antacid, Placebo MTP-101P

Who Is Running the Clinical Trial?

Gut-Brain-Axis Therapeutics Inc.

Lead Sponsor

Trials

2

Recruited

80+