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Trial record 1 of 1 for:    NCT05465148
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Microbiome Determinants of Neurological and Gastrointestinal Symptoms of Autism Spectrum Disorder (ASD)

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ClinicalTrials.gov Identifier: NCT05465148
Recruitment Status : Recruiting
First Posted : July 19, 2022
Last Update Posted : August 8, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Microbiome Determinants of Neurological and Gastrointestinal Symptoms of Autism Spectrum Disorder (ASD)
Actual Study Start Date : May 14, 2022
Estimated Primary Completion Date : May 2032
Estimated Study Completion Date : May 2032

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Prevalence of species in samples from people with ASD [ Time Frame: 10 years ]
    Prevalence of species in samples from people with ASD compared to non-ASD samples

  2. Prevalence of species in samples that led to successful FMT therapy [ Time Frame: 10 years ]
    Prevalence of species in samples that led to successful FMT therapy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05465148


Contacts
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Contact: Ryan Toma (425) 300-6933 studies@viome.com
Contact: Momchilo Vuyisich (425) 300-6933 studies@viome.com

Locations
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United States, Washington
Viome Life Sciences Active, not recruiting
Bothell, Washington, United States, 98011
Mexico
Novel Biome Recruiting
Rosarito, Zona Centro, Mexico, 22701
Contact: Jason Klop         
Sponsors and Collaborators
Viome
Investigators
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Principal Investigator: Momchilo Vuyisich Viome
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Responsible Party: Viome
ClinicalTrials.gov Identifier: NCT05465148    
Other Study ID Numbers: V205
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: August 8, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Viome:
Fecal Matter Transplant
FMT
Autism
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders