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
|Condition or disease|
|Autism Spectrum Disorder|
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|
|Estimated Enrollment :||1000 participants|
|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|
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.
- 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
- 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
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
|Contact: Ryan Toma||(425) firstname.lastname@example.org|
|Contact: Momchilo Vuyisich||(425) email@example.com|
|United States, Washington|
|Viome Life Sciences||Active, not recruiting|
|Bothell, Washington, United States, 98011|
|Rosarito, Zona Centro, Mexico, 22701|
|Contact: Jason Klop|
|Principal Investigator:||Momchilo Vuyisich||Viome|