Functional GI Disease Registry

NCT05295446 | Enrolling By Invitation

• 1 other identifier: 2015P002637
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Functional Gastrointestinal Disorders

Outcome Measures

Primary Outcomes (11)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years or older with a functional GI disorder

You may qualify if:

• years of age or older
• Rome IV criteria for a functional GI disorder

You may not qualify if:

• Acute illness
• Known bleeding disorder
• Awaiting transplantation
• Known diagnosis of Inflammatory Bowel Disease
• Use of antibiotics in last 2 months

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Kyle Staller, MD MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 25, 2022
• Study Start: February 11, 2016
• Primary Completion (Estimated): June 4, 2026
• Study Completion (Estimated): June 4, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-11

Locations

US (1)