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Enrolling by Invitation

NCT Number: NCT05295446

Functional GI Disease Registry

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.

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Key information

Conditions

Functional Gastrointestinal Disorders Digestive System Diseases Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Microbiome 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.

  5. Microbiome analysis

    Time frame: 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.

  6. Microbiome analysis

    Time frame: 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.

  7. 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.

  8. Diet and Lifestyle Questionnaire

    Time frame: Baseline visit

    This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.

  9. Diet and Lifestyle Questionnaire

    Time frame: 3 months after enrollment

    This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.

  10. Diet and Lifestyle Questionnaire

    Time frame: 6 months after enrollment

    This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.

  11. Diet and Lifestyle Questionnaire

    Time frame: 1 year after enrollment

    This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Acronym: FGIDR

Important dates

Study start
2016
Primary completion
2026
Study completion
2026
First posted
Mar 25, 2022
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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