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

NCT04630847 Phase 1 NOT_YET_RECRUITING

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.

Details

Lead sponsor	ProgenaBiome
Phase	Phase 1
Status	NOT_YET_RECRUITING
Enrolment	10
Start date	2025-12
Completion	2027-07

Conditions

• Autism
• Autism Spectrum Disorder

Interventions

• Fecal Microbiota Transplant

Primary outcomes

• ATEC — 52 Weeks
  Number of participants with changes in the Autism Treatment Evaluation Checklist scores
• QoLA — 52 Weeks
  Number of participants with changes in Quality of Life Autism scores
• CARS-2 — 52 Weeks
  Number of participants with changes in Childhood Autism Rating Scale 2 scores
• SRS-2 — 52 weeks
  Number of patients with changes in SRS-2 scores
• Behavioral changes — 52 weeks
  Changes in reported incidence of disturbances in non-core aspects of behavior or function
• GSRS — 52 weeks
  Number of patients with reported changes in GSRS measure of GI disturbances

Countries

United States