Functional GI Disease Registry

Status

Enrolling by invitation

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05295446

Acronym

FGIDR

Enrollment

500

Registered

2022-03-25

Start date

2016-02-11

Completion date

2027-07-01

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional Gastrointestinal Disorders

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.
Diet and Lifestyle Questionnaire	Baseline visit	This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKyle Staller, MD MPH

Massachusetts General Hospital

Outcome results