- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05295446
Functional GI Disease Registry (FGIDR)
May 6, 2022 updated by: Kyle Staller, MD, MPH, Massachusetts General Hospital
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.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Anticipated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients 18 years or older with a functional GI disorder
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline visit
|
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.
|
Baseline visit
|
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.
|
Baseline visit
|
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.
|
Baseline visit
|
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.
|
3 months after enrollment
|
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.
|
6 months after enrollment
|
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.
|
1 year after enrollment
|
Diet and Lifestyle Questionnaire
Time Frame: Baseline visit
|
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
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Baseline visit
|
Diet and Lifestyle Questionnaire
Time Frame: 3 months after enrollment
|
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
|
3 months after enrollment
|
Diet and Lifestyle Questionnaire
Time Frame: 6 months after enrollment
|
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
|
6 months after enrollment
|
Diet and Lifestyle Questionnaire
Time Frame: 1 year after enrollment
|
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
|
1 year after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 11, 2016
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
March 1, 2022
First Submitted That Met QC Criteria
March 16, 2022
First Posted (Actual)
March 25, 2022
Study Record Updates
Last Update Posted (Actual)
May 9, 2022
Last Update Submitted That Met QC Criteria
May 6, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015P002637
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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