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

NCT05465148 | Withdrawn

• 1 other identifier: V205
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Autism Spectrum Disorder

Keywords

Fecal Matter Transplant; FMT; Autism

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Viome: lead

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Momchilo Vuyisich

  Viome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 19, 2022
• Study Start: May 14, 2022
• Primary Completion: August 16, 2023
• Study Completion: August 16, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10