Familial Fecal Microbiota Transplant for the Treatment of Subjects With Autism Spectrum Disorders
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorProgenaBiome
About this trial
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.
Eligibility criteria
Qualifiers
Subject at least six years of age.
Subject has confirmed diagnosis of ASD based on the DSM-V.
Subject with ASD whose parents/caregiver/guardian/LAR can complete informed consent process.
A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
Disqualifiers
Female subjects who are pregnant, nursing, or intend to become pregnant during the study period.
Subjects whose caregivers are unable/unwilling to cooperate with the protocol requirements.
Subject will be excluded who are suffering with Rett syndrome and Childhood Disintegrative Disorder.
Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.
Trial design
Treatments tested in this trial
- Fecal Microbiota Transplant
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
ProgenaBiome
Lead sponsor
Ventura Clinical Trials
Collaborator
Microbiome Research Foundation
Collaborator
Source ClinicalTrials.gov