Functional Gastrointestinal DisordersFGIDRNCT05295446
Functional GI Disease Registry
An observational study of Functional Gastrointestinal Disorders, run by Massachusetts General Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Functional Gastrointestinal Disorders
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2016to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients 18 years or older with a functional GI disorder
Who may be able to join
- 18 years of age or older
- Rome IV criteria for a functional GI disorder
Who cannot join
- Acute illness
- Known bleeding disorder
- Awaiting transplantation
- Known diagnosis of Inflammatory Bowel Disease
- Use of antibiotics in last 2 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
- Medical subject headings
- Gastrointestinal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year after enrollment
Diet and Lifestyle Questionnaire
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
Measured: Baseline visit
Diet and Lifestyle Questionnaire
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
Measured: 3 months after enrollment
Diet and Lifestyle Questionnaire
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
Measured: 6 months after enrollment
Diet and Lifestyle Questionnaire
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start11 Feb 2016
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional Gastrointestinal DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Staller, MD, MPH, Massachusetts General Hospital
- Investigators
- Kyle Staller, MD MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295446
- Sponsor's protocol ID
- 2015P002637
- Acronym
- FGIDR
- Status last verified
- Nov 2025
- First submitted
- 1 Mar 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional GI Disease Registry
- ClinicalTrials.gov ID
- NCT05295446
- Acronym / sponsor ID
- FGIDR / 2015P002637
- Conditions
- Functional Gastrointestinal Disorders
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 11 Feb 2016 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years or older with a functional GI disorder
Key inclusion criteria (2 listed)
- 18 years of age or older
- Rome IV criteria for a functional GI disorder
Key exclusion criteria (5 listed)
- Acute illness
- Known bleeding disorder
- Awaiting transplantation
- Known diagnosis of Inflammatory Bowel Disease
- Use of antibiotics in last 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Diet and Lifestyle Questionnaire
Time frame: Baseline visit
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
Diet and Lifestyle Questionnaire
Time frame: 3 months after enrollment
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
Diet and Lifestyle Questionnaire
Time frame: 6 months after enrollment
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
Diet and Lifestyle Questionnaire
Time frame: 1 year after enrollment
This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyle Staller, MD MPH principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Functional Gastrointestinal Disorders, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Nucleotide Polymorphism (SNP) genotyping (time frame: Baseline visit). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.