[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652121":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":31,"locations":40,"responsibleParty":87,"collaborators":90,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":23,"eligibilityCriteria":99,"healthyVolunteers":100,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":23,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":43,"whyStopped":23,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"University Hospitals Cleveland Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Crohn's participants","EXPERIMENTAL","Crohn's participants will consume artificial sweetener: sucralose",[13],"Other: Sucralose (non-nutritive sweetener)",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy Controls","Healthy control participants will consume artificial sweetener: sucralose",[13],[19],{"type":6,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"Sucralose (non-nutritive sweetener)","Participants will consume 2 sachets\u002Fday during the exposure period resulting in the following daily dose: sucralose 2.5mg\u002Fkg. This dose is below the acceptable daily intakes (ADI) of 5mg\u002Fkg.",[9,15],null,[25,28],{"name":26,"affiliation":5,"role":27},"Fabio Cominelli, MD PhD","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":27},"Abigail Raffner, RD PhD","Case Western Reserve University",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":23,"email":35},"CONTACT","216-327-6003","Abigail.Raffner@uhhospitals.org",{"name":37,"role":33,"phone":38,"phoneExt":23,"email":39},"Sargun Singh, M.B.B.S.","216-333-6085","sargun.singh@uhhospitals.org",[41,62,75],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"UH Minoff Health Center","RECRUITING","Chagrin Falls","Ohio","44122","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-81.3865,41.43616,{"lat":53,"lon":52},[56,59],{"name":57,"role":33,"phone":23,"phoneExt":23,"email":58},"Abigail Basson, RD PhD","Abigail.Basson@uhhospitals.org",{"name":60,"role":61,"phone":23,"phoneExt":23,"email":23},"Jeffry Katz, MD","SUB_INVESTIGATOR",{"facility":5,"status":43,"city":63,"state":45,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Cleveland","44106",{"type":50,"coordinates":66},[67,68],-81.69541,41.4995,{"lat":68,"lon":67},[71,72,74],{"name":57,"role":33,"phone":23,"phoneExt":23,"email":58},{"name":73,"role":61,"phone":23,"phoneExt":23,"email":23},"Vu Nguyen, MD",{"name":60,"role":61,"phone":23,"phoneExt":23,"email":23},{"facility":76,"status":43,"city":77,"state":45,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"UH Westlake Health Center","Westlake","44145",{"type":50,"coordinates":80},[81,82],-81.91792,41.45532,{"lat":82,"lon":81},[85,86],{"name":57,"role":33,"phone":23,"phoneExt":23,"email":58},{"name":73,"role":61,"phone":23,"phoneExt":23,"email":23},{"type":27,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Fabio Cominelli","Professor",[91],{"name":92,"class":6},"Crohn's and Colitis Foundation","100652121","non-nutritive-sweeteners-in-inflammatory-bowel-disease-100652121",false,"NCT07769437","Non-nutritive Sweeteners in Inflammatory Bowel Disease","The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease","Inclusion Criteria:\n\nAge range from: 18 to 70 years. Male or female. Documented diagnosis of Crohns disease. CD outpatients in remission; Harvey Bradshaw- index in remission (\\\u003C6 score).\n\nCapable of providing consent to participate. Able to complete daily surveys and take oral nutrition. Able to record meal intake. Healthy controls with no diagnosis of IBD or Irritable Bowel Syndrome (IBS).\n\nExclusion Criteria:\n\nShort bowel syndrome. Hospitalized patients. Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients.\n\nKnown drug abuse. Known parasitic disease of the digestive system. Symptomatic intestinal stricture\u002Fnarrowing. Presence of an ostomy. Known active malignancy. Antibiotic use within last 14 days. Well-founded doubt about the patients cooperation. Existing pregnancy or lactation. History of \\\u003C1 natural bowel movements per 3 consecutive days. Unable to access to technology that permits the daily completion of study related activities.\n\nChange in IBD medication within past 4 weeks. Body mass Index \\\u003C18 kg\u002Fm or ≥35 kg\u002Fm. Documented C.difficile colitis within four weeks of screening. Bariatric surgery Phenylketonuria",true,"ALL","18 Years","70 Years",{"count":105,"type":106},40,"ESTIMATED","INTERVENTIONAL",[109],"NA","This study will focus on the commonly used non-nutritive sweetener (NNS) sucralose (2 sachets\u002Fday resulting in daily dose: sucralose 2.5mg\u002Fkg) and its role in changing the gut microbiota in humans with IBD, compared to healthy non-IBD individuals. We will focus on studying IBD patients affected with CD as a proof of principle that could be tested later in other IBD subtype (ulcerative colitis or others specific surgical conditions).",[112,113],"Inflamatory Bowel Disease","Crohn Disease (CD)",[115,116,117,118,119,120,121],"sweeteners","sucralose","inflammatory bowel disease","crohn's disease","IBD","CD","artificial sweeteners","2026-08-11",{"date":124,"type":125},"2026-08-18","ACTUAL",{"date":127,"type":125},"2025-02-03",{"date":129,"type":106},"2026-12",{"name":5,"class":6},3]