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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
FMT utilizing stool from first degree relatives
ProgenaBiome
Ventura, California, United States
ATEC
Number of participants with changes in the Autism Treatment Evaluation Checklist scores
Time frame: 52 Weeks
QoLA
Number of participants with changes in Quality of Life Autism scores
Time frame: 52 Weeks
CARS-2
Number of participants with changes in Childhood Autism Rating Scale 2 scores
Time frame: 52 Weeks
SRS-2
Number of patients with changes in SRS-2 scores
Time frame: 52 weeks
Behavioral changes
Changes in reported incidence of disturbances in non-core aspects of behavior or function
Time frame: 52 weeks
GSRS
Number of patients with reported changes in GSRS measure of GI disturbances
Time frame: 52 weeks
abbrvCDAI
Number of patients with changes in abbrevCDAI scores
Time frame: 52 weeks
HSPP
Number of subjects with changes in quality of life metric HSPP
Time frame: 52 weeks
Shannon Diversity Index
Changes in Shannon Diversity index compared between pre and post FMT scores
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Time frame: 52 Weeks
Microbiome changes
Number of subjects with changes to microbiome relative abundance and composition
Time frame: 52 weeks