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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05295446
Other study ID # 2015P002637
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


Related Conditions & MeSH terms


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
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