[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05295446":3,"trial-entities:NCT05295446":81,"trial-summary:NCT05295446":90},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":18,"study_type":19,"primary_purpose":14,"phases":20,"enrollment_info":21,"interventions":24,"primary_outcomes":25,"secondary_outcomes":48,"sex":49,"minimum_age":50,"maximum_age":14,"healthy_volunteers":14,"eligibility_criteria":51,"std_ages":62,"locations":65,"central_contacts":74,"overall_officials":75,"references":79,"see_also_links":80},"NCT05295446","2015P002637","Functional GI Disease Registry","ENROLLING_BY_INVITATION","2026-06-04","2025-11","2025-11-04","2016-02-11","Massachusetts General Hospital","OTHER",null,"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.",[17],"Functional Gastrointestinal Disorders",[],"OBSERVATIONAL",[],{"count":22,"type":23},500,"ESTIMATED",[],[26,30,32,34,36,38,40,42,45,46,47],{"measure":27,"description":28,"timeFrame":29},"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",{"measure":31,"description":28,"timeFrame":29},"Whole genome analysis",{"measure":33,"description":28,"timeFrame":29},"Proteomics",{"measure":35,"description":28,"timeFrame":29},"Microbiome analysis",{"measure":35,"description":28,"timeFrame":37},"3 months after enrollment",{"measure":35,"description":28,"timeFrame":39},"6 months after enrollment",{"measure":35,"description":28,"timeFrame":41},"1 year after enrollment",{"measure":43,"description":44,"timeFrame":29},"Diet and Lifestyle Questionnaire","This questionnaire evaluates patients' diet, lifestyle, and symptoms relating to their functional GI disorder.",{"measure":43,"description":44,"timeFrame":37},{"measure":43,"description":44,"timeFrame":39},{"measure":43,"description":44,"timeFrame":41},[],"ALL","18 Years",{"inclusion":52,"exclusion":55,"raw_text":61},[53,54],"18 years of age or older","Rome IV criteria for a functional GI disorder",[56,57,58,59,60],"Acute illness","Known bleeding disorder","Awaiting transplantation","Known diagnosis of Inflammatory Bowel Disease","Use of antibiotics in last 2 months","Inclusion Criteria:\n\n* 18 years of age or older\n* Rome IV criteria for a functional GI disorder\n\nExclusion Criteria:\n\n* Acute illness\n* Known bleeding disorder\n* Awaiting transplantation\n* Known diagnosis of Inflammatory Bowel Disease\n* Use of antibiotics in last 2 months",[63,64],"ADULT","OLDER_ADULT",[66],{"facility":12,"city":67,"state":68,"zip":69,"country":70,"geoPoint":71},"Boston","Massachusetts","02114","United States",{"lat":72,"lon":73},42.35843,-71.05977,[],[76],{"name":77,"affiliation":12,"role":78},"Kyle Staller, MD MPH","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":82,"biomarkers":89},[83,84,85,86,87,88],"Functional constipation","Functional diarrhea","Functional disorder of gastrointestinal tract","Irritable Bowel Syndrome","Nausea","Nonulcer dyspepsia",[],{"nct_id":4,"found":91,"summary":14,"prompt_version":14},false]