Fecal Microbiota Transplant for Autism

Recruiting in Palo Alto (17 mi)

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: ProgenaBiome

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment for people with Autism Spectrum Disorder that involves taking an antibiotic for a period of time followed by a procedure involving gut health from a family member. The goal is to improve social skills and language by enhancing gut health.

Eligibility Criteria

This trial is for individuals at least two years old with a confirmed diagnosis of Autism Spectrum Disorder (ASD) who are stable on medications and receiving community or school interventions. Participants need a reliable caregiver to report side effects. Males with partners of childbearing potential must use birth control. Exclusions include pregnancy, nursing, unwilling caregivers, certain medical conditions like uncontrolled seizures, substance abuse, major surgeries like gastric bypass or total colectomy planned or done.

Inclusion Criteria

I am getting help for autism at school or in the community.

A reliable parent or caregiver who can report the side effects and communicate effectively with the research team

A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.

Exclusion Criteria

I cannot stop taking my diarrhea medication before the study.

Hepatic values greater than 20

Unable to stop opiate treatment unless on a stable dose including PRN dosing, and no dose increase planned for the duration of the study

Participant Groups

The study tests the effect of fecal microbiota transplant from family members in treating social deficits and language delays in ASD patients after a preliminary treatment with Vancomycin for six weeks. It's an open-label trial where everyone knows what treatment is being given.

Group I: Autism Subjects Experimental Treatment 1 Intervention

These subjects will be administered fecal microbiota transplant by colonoscopy

Fecal Microbiota Transplant is already approved in United States, European Union, Canada, Australia for the following indications:

🇺🇸 Approved in United States as Fecal Microbiota Transplantation for:

• Recurrent and refractory Clostridioides difficile infection

🇪🇺 Approved in European Union as Faecal Microbiota Transplantation for:

• Recurrent and refractory Clostridioides difficile infection

🇨🇦 Approved in Canada as Fecal Microbiota Transplantation for:

• Recurrent and refractory Clostridioides difficile infection

🇦🇺 Approved in Australia as Faecal Microbiota Transplantation for:

• Recurrent and refractory Clostridioides difficile infection

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

ProgenaBiome Ventura, CA

Who Is Running the Clinical Trial?

ProgenaBiome Lead Sponsor

Ventura Clinical Trials Collaborator

References