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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05465148
• Other study ID #: V205
• Status: Withdrawn
• Start date: May 14, 2022
• Est. completion date: August 16, 2023

Study information

• Verified date: October 2023
• Source: Viome
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 16, 2023
• Est. primary completion date: August 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Viome

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of species in samples from people with ASD	Prevalence of species in samples from people with ASD compared to non-ASD samples	10 years
Primary	Prevalence of species in samples that led to successful FMT therapy	Prevalence of species in samples that led to successful FMT therapy	10 years