FGIDR: Functional GI Disease Registry

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05295446

Collaborator

(none)

500

Enrollment

Location

87.6

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

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
Functional Gastrointestinal Disorders

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Functional GI Disease Registry

Actual Study Start Date :

Feb 11, 2016

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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.

Responsible Party:

Kyle Staller, MD, MPH, Principal Investigator, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT05295446

Other Study ID Numbers:

2015P002637

First Posted:

Mar 25, 2022

Last Update Posted:

May 9, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastrointestinal Diseases

Digestive System Diseases

Study Results

No Results Posted as of May 9, 2022