Functional GI Disease Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Functional Gastrointestinal Disorders
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Microbiome analysis
- Status
- Enrolling By Invitation
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Investigators
Kyle Staller, MD, MPH
Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Microbiome analysis
Time Frame: 1 year after enrollment
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.
Proteomics
Time Frame: Baseline visit
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.
Whole genome analysis
Time Frame: Baseline visit
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.
Diet and Lifestyle Questionnaire
Time Frame: 1 year after enrollment
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
Single Nucleotide Polymorphism (SNP) genotyping
Time Frame: Baseline visit
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.