Functional GI Disease Registry

Study Overview
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Brief Summary
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The goal of this study is to establish a prospective observational cohort of individuals with functional GI disorders (functional constipation, irritable bowel syndrome, chronic nausea, functional diarrhea, and functional dyspepsia, as well as a subset of these individuals starting neuromodulation for their functional GI disorder) and collect clinical information and specimens. This information will be used in order to establish a patient registry with detailed clinical data and a specimen repository for future research as well as to specifically identify environmental, genetic, physiological, and psycho-social factors associated with functional GI disorders.

Official Title
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Functional GI Disease Registry

Conditions
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Functional Gastrointestinal Disorders

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Rome IV criteria for a functional GI disorder Exclusion Criteria: Acute illness Known bleeding disorder Awaiting transplantation Known diagnosis of Inflammatory Bowel Disease Use of antibiotics in last 2 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single Nucleotide Polymorphism (SNP) genotyping | In this study, we anticipate identifying differential functional genomic profiles (metagenomes) and metabolites (metabolomes) between patients with different functional GI disorders, with detailed species-specific reconstruction of microbial metabolic pathways, their complement of gene orthologs, taxonomic distributions, and abundance profiles. | Baseline visit | 
| Whole genome analysis | In this study, we anticipate identifying differential functional genomic profiles (metagenomes) and metabolites (metabolomes) between patients with different functional GI disorders, with detailed species-specific reconstruction of microbial metabolic pathways, their complement of gene orthologs, taxonomic distributions, and abundance profiles. | Baseline visit | 
| Proteomics | In this study, we anticipate identifying differential functional genomic profiles (metagenomes) and metabolites (metabolomes) between patients with different functional GI disorders, with detailed species-specific reconstruction of microbial metabolic pathways, their complement of gene orthologs, taxonomic distributions, and abundance profiles. | Baseline visit | 
| Microbiome analysis | In this study, we anticipate identifying differential functional genomic profiles (metagenomes) and metabolites (metabolomes) between patients with different functional GI disorders, with detailed species-specific reconstruction of microbial metabolic pathways, their complement of gene orthologs, taxonomic distributions, and abundance profiles. | Baseline visit | 
| Microbiome analysis | In this study, we anticipate identifying differential functional genomic profiles (metagenomes) and metabolites (metabolomes) between patients with different functional GI disorders, with detailed species-specific reconstruction of microbial metabolic pathways, their complement of gene orthologs, taxonomic distributions, and abundance profiles. | 3 months after enrollment | 
| Microbiome analysis | In this study, we anticipate identifying differential functional genomic profiles (metagenomes) and metabolites (metabolomes) between patients with different functional GI disorders, with detailed species-specific reconstruction of microbial metabolic pathways, their complement of gene orthologs, taxonomic distributions, and abundance profiles. | 6 months after enrollment | 
| Microbiome analysis | In this study, we anticipate identifying differential functional genomic profiles (metagenomes) and metabolites (metabolomes) between patients with different functional GI disorders, with detailed species-specific reconstruction of microbial metabolic pathways, their complement of gene orthologs, taxonomic distributions, and abundance profiles. | 1 year after enrollment | 
| Diet and Lifestyle Questionnaire | This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder. | Baseline visit | 
| Diet and Lifestyle Questionnaire | This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder. | 3 months after enrollment | 
| Diet and Lifestyle Questionnaire | This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder. | 6 months after enrollment | 
| Diet and Lifestyle Questionnaire | This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder. | 1 year after enrollment |