Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders

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.

Conditions

• Autism Spectrum Disorder
• Gastro-Intestinal Disorder
• Constipation
• Diarrhea

Interventions

COMBINATION_PRODUCT

MTP-101P

MTP-101P is comprised of standardized dose of total fecal microbiota purified from the stool of healthy donors. Donors are carefully screened via health status questionnaires, physical examinations, reviews of comprehensive medical history, clinical laboratory evaluations, serologic and genomic tests for infectious diseases and metabolic health, and stool-related pathogen testing. The material from the donors is purified to remove the majority of non-bacterial material, washed, lyophilized, and provided to the patient in a sachet contained within a mixing bottle.

COMBINATION_PRODUCT

Vancomycin

Oral vancomycin is an antibiotic used for treating C. difficile-associated diarrhea and staphylococcal-induced enterocolitis. Duration: 14 Days

COMBINATION_PRODUCT

Miralax

Miralax is a common over-the-counter laxative and bowel cleanse

COMBINATION_PRODUCT

Antacid

The antacid will be aluminum/magnesium hydroxide, 1x/day, 5 minutes before the MTP-101P. Each 5 ml consists of Aluminum Hydroxide - 200 mg, Magnesium Hydroxide - 200 mg, and Simethicone - 20 mg. If some participants cannot tolerate the aluminum/magnesium hydroxide, we will allow calcium carbonate alternatives equivalent in acid neutralizing capacity. Duration: 12 weeks

COMBINATION_PRODUCT

Placebo MTP-101P

The same packaging will be used as for MTP-101P, but the sachets will contain a freeze-dried mixture of normal saline containing 10% Trehalose. Duration: 12 weeks

COMBINATION_PRODUCT

Placebo Vancomycin

Same packaging and liquid carrier and flavoring used as for the oral vancomycin, but no vancomycin. Duration: 14 days

Sponsors & Collaborators

• Gut-Brain-Axis Therapeutics Inc.

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

4 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-20

Primary Completion

2025-07-17

Completion

2026-08-17

FDA Drug

Yes

Countries

• United States

Study Locations