[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658401":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":38,"studyPopulation":30,"armGroups":39,"interventions":50,"overallOfficials":55,"centralContacts":61,"locations":71,"responsibleParty":120,"collaborators":122,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":30,"eligibilityCriteria":131,"healthyVolunteers":132,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":30,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":146,"overallStatus":74,"whyStopped":30,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Case Western Reserve University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Change in fecal microbiome","Quantify the change in the fecal microbiome as measured by metagenome analysis","Baseline, 14 days post-baseline, and 21 days post-intervention",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Change in Fecal Myleoperoxidase activity (MPO)","Quantify the change in fecal MPO",{"measure":18,"description":19,"timeFrame":12},"Change in Fecal Calprotectin","Quantify the change in fecal calprotectin",{"measure":21,"description":22,"timeFrame":12},"Change in Short Crohn's Disease Activity Index (sCDAI)","Quantify before\u002Fafter intervention self-reported indices for Crohn's Disease patients using the sCDAI. The sCDAI, a shortened version of the Crohns Disease Activity Index, is a 4-question survey with abdominal pain, diarrhea frequency, and general well-being domains, reported over the previous 7 days. Score scale for sCDAI is: \\\u003C150 define remission, 150-219 mild activity, 220-450 moderate activity, \\>450 severe activity.",{"measure":24,"description":25,"timeFrame":12},"Change in Crohns Disease Activity Index (CDAI)","Quantify before\u002Fafter intervention indices for Crohn's Disease patients using the CDAI. CDAI score is: \\\u003C150 define remission, 150-219 mild activity, 220-450 moderate activity, \\>450 severe activity.",{"measure":27,"description":28,"timeFrame":29},"Change in C-reactive protein (CRP)","Quantify change in CRP before\u002Fafter intervention","14 days post-baseline and 21 days post-intervention",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"NON_RANDOMIZED","PARALLEL","Two groups; Crohn's and Healthy participants who undergo the same intervention","BASIC_SCIENCE",{"masking":37,"maskingDescription":30,"whoMasked":30},"NONE","Participation in this study will last for a minimum of 35 days (Phase I: 14-days; baseline with removal of all NNS (eg saccharin, sucralose, steviosides, aspartame, acesulfame-k, erythritol) from the diet, Phase II: 21-days; sucralose intervention, and will involve one virtual visit (study visit 1) and two in-person study visits (study visit 2 and study visit 3).\n\nFecal \\& urine samples will be collected before\u002Fafter each phase. Blood will also be collected.",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Crohn's participants","EXPERIMENTAL","Crohn's participants will consume the artificial sweetener sucralose",[45],"Other: Sucralose (non-nutritive sweetener)",{"label":47,"type":42,"description":48,"interventionNames":49},"Healthy Controls","Healthy control participants will consume the artificial sweetener sucralose",[45],[51],{"type":6,"name":52,"description":53,"armGroupLabels":54,"otherNames":30},"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.",[41,47],[56,59],{"name":57,"affiliation":5,"role":58},"Fabio Cominelli, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":60,"affiliation":5,"role":58},"Abigal Raffner, PhD, RD",[62,67],{"name":63,"role":64,"phone":65,"phoneExt":30,"email":66},"Sargun Singh, M.B.B.S.","CONTACT","216-333-6085","sks197@case.edu",{"name":68,"role":64,"phone":69,"phoneExt":30,"email":70},"Abigail Raffner, RD, PhD","216-327-6003","Abigail.Raffner@uhhospiatls.org",[72,93,108],{"facility":73,"status":74,"city":75,"state":76,"zip":77,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"UH Minoff Health Center","RECRUITING","Chagrin Falls","Ohio","44122","United States","US",{"type":81,"coordinates":82},"Point",[83,84],-81.3865,41.43616,{"lat":84,"lon":83},[87,90],{"name":88,"role":64,"phone":30,"phoneExt":30,"email":89},"Abigail Basson, RD PhD","Abigail.Basson@uhhospitals.org",{"name":91,"role":92,"phone":30,"phoneExt":30,"email":30},"Jeffry Katz, MD","SUB_INVESTIGATOR",{"facility":94,"status":74,"city":95,"state":76,"zip":96,"country":78,"countryCode":79,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"University Hospitals Cleveland Medical Center","Cleveland","44106",{"type":81,"coordinates":98},[99,100],-81.69541,41.4995,{"lat":100,"lon":99},[103,105,107],{"name":88,"role":64,"phone":104,"phoneExt":30,"email":89},"1-888-844-8447",{"name":106,"role":92,"phone":30,"phoneExt":30,"email":30},"Vu Nguyen, MD",{"name":91,"role":92,"phone":30,"phoneExt":30,"email":30},{"facility":109,"status":74,"city":110,"state":76,"zip":111,"country":78,"countryCode":79,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"UH Westlake Health Center","Westlake","44145",{"type":81,"coordinates":113},[114,115],-81.91792,41.45532,{"lat":115,"lon":114},[118,119],{"name":88,"role":64,"phone":30,"phoneExt":30,"email":89},{"name":106,"role":92,"phone":30,"phoneExt":30,"email":30},{"type":121,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[123],{"name":124,"class":6},"Crohn's and Colitis Foundation","100658401","investigating-the-effect-of-the-non-nutritive-sweetener-sucralose-in-inflammatory-bowel-disease-100658401",false,"NCT07852273","Investigating the Effect of the Non-nutritive Sweetener Sucralose in Inflammatory Bowel Disease","The Effect of Non-Nutritive Food Sweeteners in Inflammatory Bowel Disease","Inclusion Criteria:\n\n* Age range from 18 to 75 years\n* Male or female\n* Documented diagnosis of Crohns disease. CD outpatients in remission; Harvey Bradshaw- index in remission (\\\u003C6 score)\n* Capable of providing consent to participate.\n* Able to complete daily surveys and take oral nutrition\n* Able to record meal intake\n* Healthy controls with no diagnosis of Irritable Bowel Disease IBD or Irritable Bowel Syndrome (IBS)\n\nExclusion Criteria:\n\n* Short bowel syndrome\n* Hospitalized patients\n* Individuals who lack consent capacity, including the mentally ill, prisoners, cognitively impaired participants, dementia patients\n* Known drug abuse\n* Known parasitic disease of the digestive system\n* Symptomatic intestinal stricture\u002Fnarrowing\n* Presence of an ostomy\n* Known active malignancy\n* Antibiotic use within last 14 days\n* Well-founded doubt about the patient's cooperation.\n* Existing pregnancy or lactation\n* History of \\\u003C1 natural bowel movements per 3 consecutive days\n* Unable to access technology that permits the daily completion of study related activities\n* Change in IBD medication within past 4 weeks\n* Body mass Index \\\u003C16 kg\u002Fm or ≥40 kg\u002Fm\n* Documented C.difficile colitis within four weeks of screening\n* Bariatric surgery\n* Phenylketonuria",true,"ALL","18 Years","75 Years",{"count":137,"type":138},40,"ESTIMATED","INTERVENTIONAL",[141],"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 Inflammatory Bowel Disease (IBD), compared to healthy non-IBD individuals. We will focus on studying IBD patients affected with Crohn's Disease (CD) as a proof of principle that could be tested later in other IBD subtypes (ulcerative colitis or others specific surgical conditions).",[144,145],"Inflamatory Bowel Disease","Crohn Disease (CD)",[147,148,149,150,151,152,153],"sweeteners","sucralose","inflammatory bowel disease","crohn's disease","IBD","CD","artificial sweeteners","2026-09-25",{"date":156,"type":157},"2026-10-01","ACTUAL",{"date":159,"type":157},"2024-04-18",{"date":161,"type":138},"2027-06",{"name":5,"class":6},3]