Functional GI Disease Registry

Functional Gastrointestinal Disorders Clinical Trial

— FGIDR  

Official title:

Functional GI Disease Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05295446
• Other study ID #: 2015P002637
• Status: Enrolling by invitation
• Start date: February 11, 2016
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Functional Gastrointestinal Disorders
• Gastrointestinal Diseases

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Diet and Lifestyle Questionnaire	This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.	Baseline visit
Primary	Diet and Lifestyle Questionnaire	This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.	3 months after enrollment
Primary	Diet and Lifestyle Questionnaire	This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.	6 months after enrollment
Primary	Diet and Lifestyle Questionnaire	This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.	1 year after enrollment