Functional GI Disease Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Functional Gastrointestinal Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Single Nucleotide Polymorphism (SNP) genotyping [Time frame: Baseline visit]
- Whole genome analysis [Time frame: Baseline visit]
- Proteomics [Time frame: Baseline visit]
- Microbiome analysis [Time frame: Baseline visit]
- Microbiome analysis [Time frame: 3 months after enrollment]
- Microbiome analysis [Time frame: 6 months after enrollment]
- Microbiome analysis [Time frame: 1 year after enrollment]
- Diet and Lifestyle Questionnaire [Time frame: Baseline visit]
- Diet and Lifestyle Questionnaire [Time frame: 3 months after enrollment]
- Diet and Lifestyle Questionnaire [Time frame: 6 months after enrollment]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT05295446 · 2015P002637