[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577018":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":35,"collaborators":37,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":20,"overallStatus":67,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":20},{"fullName":5,"class":6},"Cook Children's Health Care System","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with IBS","EXPERIMENTAL","CLE will be used to observe changes in the duodenal mucosa once the allergen is introduced.",[13],"Device: Confocal Laser Endomicroscopy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Confocal Laser Endomicroscopy","1. The Endo microscope probe will be prepped in channel #1 and normal saline (30 ml) will be flushed into the duodenal mucosa through channel # 2 which will serve as a control. Inject 1-3ml fluorescein 10% intravenously.\n2. The duodenal mucosa is assessed at a minimum of four sites (20 seconds each\n3. The first potential allergen will be sprayed via catheter onto the mucosa.\n4. After 2 minutes, three different areas of of duodenum will be assessed with the gastroflex probe for fluorescein leakage and cell shedding. If fluorescein leakage and cell shedding are visualized that is considered a positive test,no further allergy testing can be conducted. If the first allergen test is negative, irrigate and repeat steps for the next potential allergen for a maximum of three allergens per patient.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Clifton Huang, MD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Sumith Roy, MBBS, MPH","CONTACT","682-885-1790","Sumith.Roy@cookchildrens.org",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Laurie Bailey, PhD","682-885-6451","Laurie.Bailey@cookchildrens.org",{"type":36,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[38,41,43,45],{"name":39,"class":40},"University of Nebraska Medical Center and Children's Hospital & Medical Center","UNKNOWN",{"name":42,"class":6},"Stanford University",{"name":44,"class":40},"Metrodora Institute",{"name":46,"class":40},"Meliora Bio ApS","100577018","endomicroscopic-evaluation-of-food-induced-gastrointestinal-mucosal-alteration-100577018",false,"NCT06792838","Endomicroscopic Evaluation of Food-induced Gastrointestinal Mucosal Alteration","A Multicenter Ambispective Evaluation of Atypical Food Allergies In-vivo Utilizing Confocal Laser Endomicroscopy in Pediatric and Adult Patients","Inclusion Criteria:\n\nPatients must meet all of the following criteria to be included in the study\n\n* Adults and children presenting with a prolonged history of IBS-like symptoms (as described by Rome IV criteria) related to food intake.\n* A negative or very low\u002Flow levels of Ig-E food allergy panel or negative skin prick test\n* Negative celiac disease work up\n\nExclusion Criteria:\n\n* If patient had a previous Esophagogastroduodenoscopy (EGD) and Colonoscopy with biopsy positive for any chronic inflammatory condition for eg. Inflammatory Bowel Disease (IBD), the patient will be excluded.\n* Pregnant or nursing at the time of CLE.\n* Known allergy to fluorescein.\n* Impaired renal function tests.\n* Active GI bleeding.","ALL","2 Years","99 Years",{"count":58,"type":59},200,"ESTIMATED","INTERVENTIONAL",[62],"NA","The overarching goal of this study is to establish a first ever registry in the U.S. to collect outcomes data to evaluate changes in the gastrointestinal (GI) mucosa following direct food application utilizing Confocal Laser Endomicroscopy (CLE). This will be assessed in pediatric and adult patients who present to the outpatient clinic with persistent irritable bowel syndrome-like symptoms while testing negative for celiac disease and have either negative or very low\u002Flow levels of Immunoglobulin E (IgE) serological tests.",[65,66],"Irritable Bowel Syndrome","Food Allergy","NOT_YET_RECRUITING","2025-02-21",{"date":70,"type":71},"2025-02-24","ACTUAL",{"date":73,"type":59},"2025-03",{"date":75,"type":59},"2034-09",{"name":5,"class":6}]