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

Part of paid clinical trials in Ventura, California.

Sponsor
ProgenaBiome
Study ID
NCT04630847
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fecal Microbiota Transplant — BIOLOGICAL
    FMT utilizing stool from first degree relatives

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Autism Subjects
    These subjects will be administered fecal microbiota transplant by colonoscopy

Primary Outcome Measure

ATEC [ Time Frame: 52 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
ProgenaBiomeVenturaCalifornia93003
Sabine Hazan, MD
805-339-0549
Jordan Daniels, MS
805-339-0549
Sabine Hazan, MD (PRINCIPAL_INVESTIGATOR)

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