Microbiome Determinants of Neurological and Gastrointestinal Symptoms of Autism Spectrum Disorder (ASD)

Withdrawn

• Conditions: Autism Spectrum Disorder

• Registration Number: NCT05465148
• Lead Sponsor: Viome

Brief Summary

This observational study aims to identify human microbiome determinants of the symptoms associate with ASD as well as identify the human microbiome determinants of the success of FMT (fecal matter transplant) therapy and to develop a statistical model that can improve FMT donor-recipient matching. Participants are recruited through NovelBiome only, this study will NOT utilize other clinical sites.

Detailed Description

This longitudinal, observational study aims to identify human microbiome determinants of the symptoms associate with ASD as well as identify the human microbiome determinants of the success of FMT therapy and to develop a statistical model that can improve FMT donor-recipient matching.

Participant phenotype data and samples are collected at several time points relative to their receiving FMT therapy.

Participants will collect stool, urine, environmental swabs, saliva, and blood at home via VLS's (Viome Life Sciences) at-home kits mailed to them by VLS. The at-home samples are collected by participants (and when appropriate LAR/guardian). The samples are then returned to VLS via postage-paid mailers (provided). These samples are analyzed by the VLS laboratory.

Study Timeline

• Study Start: 2022-05-14
• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Primary Completion: 2023-08-16
• Study Completion: 2023-08-16
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-13
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosis of ASD, from medical records, self-diagnosed and/or LAR reported (LAR = legally authorized representative)
• Plans to undergo FMT treatment at a Novel Biome Clinic
• Consented to participate in the study

Exclusion Criteria

• Active cancer therapy
• Antibiotic use within 30 days prior to starting the FMT therapy. FMT therapy itself starts with antibiotic treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of species in samples from people with ASD	10 years	Prevalence of species in samples from people with ASD compared to non-ASD samples
Prevalence of species in samples that led to successful FMT therapy	10 years	Prevalence of species in samples that led to successful FMT therapy