[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06215222":3,"trial-entities:NCT06215222":104,"trial-summary:NCT06215222":109},{"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":16,"conditions":17,"keywords":22,"study_type":25,"primary_purpose":16,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":14,"eligibility_criteria":49,"std_ages":72,"locations":75,"central_contacts":98,"overall_officials":101,"references":102,"see_also_links":103},"NCT06215222","IRB-62670","Capsule Microbiota Sampling in IBS\u002FFunctional Gastrointestinal Disease","RECRUITING","2026-12-01","2024-01","2024-01-22","2023-11-16","Stanford University","OTHER",true,"We will sample intestinal microbiota using a microbiome sampling capsule in Healthy, Irritable Bowel Syndrome (IBS), and Functional Gastrointestinal Disease.",null,[18,19,20,21],"IBS - Irritable Bowel Syndrome","Healthy","Functional Bloating","Functional Gastrointestinal Disorders",[23,24],"microbiome","Small intestine","OBSERVATIONAL",[],{"count":28,"type":29},40,"ESTIMATED",[31],{"type":13,"name":32,"description":33,"armGroupLabels":34},"Microbiota Sampling","We will sample the Saliva, Feces, and intestinal microbiome for genetic microbiome analysis and bacterial isolation",[35,36],"Healthy patients","IBS\u002FFunctional GI diasease",[38],{"measure":39,"description":40,"timeFrame":41},"Collection of 50ul of intestinal fluid from >90% of microbiome sampling capsules","Collection of 50ul of intestinal fluid from microbiome sampling capsules","1-4 years",[43],{"measure":44,"description":45,"timeFrame":41},"Isolation of liven bacteria from the intestinal fluid of >90% of microbiome sampling capsules","Isolation of liven bacteria from the intestinal fluid of \\>90% of microbiome sampling capsules","ALL","18 Years","70 Years",{"inclusion":50,"exclusion":56,"raw_text":71},[51,52,53,54,55],"Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.","American Society of Anesthesiologists (ASA) Physical Status Classification System 1 or 2 (1-A normal healthy patient or 2-A patient with mild systemic disease)","For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).","Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.","Positive for at least one clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)",[57,58,59,60,61,62,63,64,65,66,67,68,69,70],"History of any of the following:","Prior gastric or esophageal surgery, including lap banding or bariatric surgery","Bowel obstruction","Gastric outlet obstruction","Diverticulitis","Inflammatory bowel disease","Ileostomy or colostomy","Gastric or esophageal cancer","Achalasia","Esophageal diverticulum","Active Dysphagia or Odynophagia","Active medication use for any gastrointestinal conditions","Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding","Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study","Inclusion Criteria:\n\n* Males or females 18 years of age or older and 70 years of age or younger at the time of the first Screening Visit.\n* American Society of Anesthesiologists (ASA) Physical Status Classification System 1 or 2 (1-A normal healthy patient or 2-A patient with mild systemic disease)\n* For women of childbearing potential, negative urine pregnancy test within 7 days of Screening Visit. Willingness to use highly effective contraception during the entire study period (e.g.: implants, injectables, oral contraceptives, intra-uterine device or declared abstinence).\n* Subject is fluent in English and understands the study protocol and informed consent and is willing and able to comply with study requirements and sign the informed consent form.\n* Positive for at least one clinical symptoms consistent with SIBO and or IBS and or a Rome Diagnosis of functional GI disorder (Rome IV criteria)\n\nExclusion Criteria:\n\n* History of any of the following:\n\n  * Prior gastric or esophageal surgery, including lap banding or bariatric surgery\n  * Bowel obstruction\n  * Gastric outlet obstruction\n  * Diverticulitis\n  * Inflammatory bowel disease\n  * Ileostomy or colostomy\n  * Gastric or esophageal cancer\n  * Achalasia\n  * Esophageal diverticulum\n* Active Dysphagia or Odynophagia\n* Active medication use for any gastrointestinal conditions\n* Pregnancy or planned pregnancy within 30 days from Screening Visit, or breast-feeding\n* Any form of active substance abuse or dependence (including drug or alcohol abuse), unstable medical or psychiatric disorder, or any chronic condition susceptible, in the opinion of the investigator, to interfere with the conduct of the study",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"status":7,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":95},"Stanford Digestive Health Clinic","Redwood City","California","94063","United States",[83,88,91,93],{"name":84,"role":85,"phone":86,"email":87},"Sean Spencer, MD\u002FPhD","CONTACT","650-736-5555","seanspen@stanford.edu",{"name":89,"role":85,"phone":90},"Linda Nguyen, MD","(650) 736-5555",{"name":84,"role":92},"PRINCIPAL_INVESTIGATOR",{"name":94,"role":92},"Linda Nugyen, MD",{"lat":96,"lon":97},37.48522,-122.23635,[99],{"name":100,"role":85,"phone":90,"email":87},"Sean Spencer, MD,PhD",[],[],[],{"nct_id":4,"conditions":105,"biomarkers":108},[106,107],"Functional disorder of gastrointestinal tract","Irritable Bowel Syndrome",[],{"nct_id":4,"found":14,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an observational study involving 40 participants. It is not specified if participants are randomly assigned to groups or if the study is blinded.","completed","Capsule Microbiota Sampling in IBS and Functional GI Disorders","This study is looking at how to best collect samples of the tiny organisms (microbiota) living in your gut using a special capsule. Researchers will collect samples from saliva, stool (feces), and the gut itself for genetic analysis. The study includes healthy volunteers, people with Irritable Bowel Syndrome (IBS), and those with other functional gastrointestinal disorders like bloating. The main goal is to see if the capsule can successfully collect at least 50 microliters of intestinal fluid in over 90% of cases. This study is currently recruiting 40 participants, aged 18 to 70 years old, who are generally healthy.","The primary goal of collecting intestinal fluid will be measured over 1 to 4 years.",99,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]