An Open-Label Phase I Clinical Trial of Vancomycin Followed by Familial Fecal Microbiota Transplant in Adult Subjects With Autism Spectrum Disorder (ASD)
ProgenaBiome
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.
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
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject at least six years of age. 2. Subject has confirmed diagnosis of ASD based on the DSM-V. 3. Subject with ASD whose parents/caregiver/guardian/LAR can complete informed consent process. 4. A reliable parent or caregiver who can report the side effects and communicate effectively with the research team. 5. Comorbid gastrointestinal symptoms 6. Stable medications during the two months prior to enrollment. 7. Currently receiving interventions in the community or school for ASD. 8. If female and of childbearing potential, must be willing to utilize at least one highl…
Interventions
- BiologicalFecal Microbiota Transplant
FMT utilizing stool from first degree relatives
Location
- ProgenaBiomeVentura, California