๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2024-09-23

Microbiota Transplant Therapy for Children With Both Autism Spectrum Disorder and Gastrointestinal Disorders (NCT06503978)

Dosing Study of Microbiota Transplant Therapy for Children With Autism Spectrum Disorder (ASD) Who Have Gastrointestinal Disorders

๐Ÿ”ต Active, Not Recruiting Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Gut-Brain-Axis Therapeutics Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Autism/Asperger's Research Group at Arizona State University โ€” Tempe, Arizona

Age range: 4 Years to 18 Years

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Autism/Asperger's Research Group at Arizona State University โ€” Tempe, Arizona

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—