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

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.

Study Overview

• Status: Withdrawn
• Conditions: Autism Spectrum Disorder

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 Type: Observational

Contacts and Locations

Study Locations

• Mexico
  • Zona Centro
    • Rosarito, Zona Centro, Mexico, 22701
      • Recruiting
      • Novel Biome
      • Contact: Jason Klop
• United States
  • Washington
    • Bothell, Washington, United States, 98011
      • Active, not recruiting
      • Viome Life Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Up to 1000 participants (any biological sex) that have a shipping address within the USA will be enrolled. Participants of all ages will be admitted into the study; minors - under the age of 18 will be required to provide the assent form or a parental permission form, in addition to the Informed Consent Form signed by the parents/guardians prior to any study related activities.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

ASD; Individuals with Autism Spectrum Disorder indicated by medical records, self diagnosis, or reported by a legally authorized representative. Individuals may be of any age, however, minors (under the age of 18 years) will be required to provide the assent form or a parental permission form, in addition to the Informed Consent Form signed by the parents/guardians prior to any study related activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Prevalence of species in samples that led to successful FMT therapy	Prevalence of species in samples that led to successful FMT therapy	10 years

Collaborators and Investigators

• Sponsor: Viome
• Investigators: Principal Investigator: Momchilo Vuyisich, Viome

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2022
• Primary Completion (Actual): August 16, 2023
• Study Completion (Actual): August 16, 2023

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 15, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Autism; FMT; Fecal Matter Transplant
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: V205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No