Familial Fecal Microbiota Transplant for Autism Spectrum Disorders
This study is looking at whether a Familial Fecal Microbiota Transplant (FMT) can help adults with Autism Spectrum Disorder (ASD) who also have gut problems. FMT involves using stool from a close family member. Before the FMT, participants will receive a 6-week treatment with Vancomycin, an antibiotic. The study wants to see if this treatment can improve social difficulties and language delays. Researchers will measure changes using tools like the ATEC, QoLA, and CARS-2 after 52 weeks. The study is currently unclear on its recruitment status and plans to enroll 10 participants who are at least 6 years old and have an ASD diagnosis confirmed by DSM-V criteria.
- Study design
- This is an open-label study, meaning everyone knows what treatment is being given. It plans to enroll 10 participants.
- What's involved
- Participants will receive a 6-week treatment with Vancomycin, followed by a Fecal Microbiota Transplant (FMT) given by colonoscopy. The study will measure outcomes at 52 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 52 weeks after the treatment to measure outcomes.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders
At a glance
Conditions
NCT04630847
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
ProgenaBiome
Ventura, Californiastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Sabine Hazan, MD · STUDY_DIRECTOR · ProgenaBiome
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- ATEC52 Weeks
Number of participants with changes in the Autism Treatment Evaluation Checklist scores
- QoLA52 Weeks
Number of participants with changes in Quality of Life Autism scores
- CARS-252 Weeks
Number of participants with changes in Childhood Autism Rating Scale 2 scores
- SRS-252 weeks
Number of patients with changes in SRS-2 scores
- Behavioral changes52 weeks
Changes in reported incidence of disturbances in non-core aspects of behavior or function
- GSRS52 weeks
Number of patients with reported changes in GSRS measure of GI disturbances
- abbrvCDAI52 weeks
Number of patients with changes in abbrevCDAI scores
- HSPP52 weeks
Number of subjects with changes in quality of life metric HSPP