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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Autism Spectrum Disorder

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASD<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FMT, Fecal Matter Transplant, Autism