FGIDR: Functional GI Disease Registry
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- Single Nucleotide Polymorphism (SNP) genotyping [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 [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.
- Proteomics [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.
- Microbiome analysis [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.
- Microbiome analysis [3 months 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.
- Microbiome analysis [6 months 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.
- Microbiome analysis [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.
- Diet and Lifestyle Questionnaire [Baseline visit]
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
- Diet and Lifestyle Questionnaire [3 months after enrollment]
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
- Diet and Lifestyle Questionnaire [6 months after enrollment]
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
- Diet and Lifestyle Questionnaire [1 year after enrollment]
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
- Principal Investigator: Kyle Staller, MD MPH, Massachusetts General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015P002637