NCT04630847

Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders

An Open-Label Phase I Clinical Trial of Vancomycin Followed by Familial Fecal Microbiota Transplant in Adult Subjects With Autism Spectrum Disorder (ASD)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: ProgenaBiome · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays.

Detailed description

This is an open-label clinical trial to evaluate the benefits of familial fecal microbiota transplant following a 6-week treatment with Vancomycin in adult subjects with ASD for treatment of social deficits and language delays. Participants are given FMT by colonoscopy

Conditions

• Autism
• Autism Spectrum Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplant	FMT utilizing stool from first degree relatives

Timeline

• Start date: 2025-12-01
• Primary completion: 2026-12-01
• Completion: 2027-07-01
• First posted: 2020-11-16
• Last updated: 2025-09-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study