Microbiome Determinants of Neurological and Gastrointestinal Symptoms of Autism Spectrum Disorder (ASD)
NCT ID: NCT05465148
Last Updated: 2023-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2022-05-14
2023-08-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Plans to undergo FMT treatment at a Novel Biome Clinic
* Consented to participate in the study
Exclusion Criteria
* Antibiotic use within 30 days prior to starting the FMT therapy. FMT therapy itself starts with antibiotic treatment.
ALL
No
Sponsors
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Viome
INDUSTRY
Responsible Party
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Principal Investigators
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Momchilo Vuyisich
Role: PRINCIPAL_INVESTIGATOR
Viome
Other Identifiers
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V205
Identifier Type: -
Identifier Source: org_study_id
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