[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491506":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":95,"collaborators":97,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":18,"eligibilityCriteria":108,"healthyVolunteers":109,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":18,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":64,"whyStopped":18,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"University of Chicago","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Gluten challenge group","EXPERIMENTAL","Diagnosis of celiac disease by intestinal biopsy and serology for at least 12 months",[13],"Dietary Supplement: Gluten containing snack bar",{"label":15,"type":16,"description":17,"interventionNames":18},"Gluten de-challenge group","NO_INTERVENTION","Suspected celiac disease either showing typical symptoms or positive celiac disease serology",null,{"label":20,"type":16,"description":21,"interventionNames":18},"Control group","No history or symptoms of celiac disease",[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":18},"DIETARY_SUPPLEMENT","Gluten containing snack bar","Ingest snack bars containing 3 grams of gluten every day for 6 weeks.",[9],[29],{"name":30,"affiliation":5,"role":31},"Bana Jabri, MD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Sonia Kupfer, MD","CONTACT","(773) 834-1438","skupfer@bsd.uchicago.edu",{"name":39,"role":35,"phone":40,"phoneExt":18,"email":41},"Kristi Kearney, RN","773-834-7414","kkearney@bsd.uchicago.edu",[43,62,77],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"California Institute of Technology","NOT_YET_RECRUITING","Pasadena","California","91125","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-118.14452,34.14778,{"lat":55,"lon":54},[58],{"name":59,"role":35,"phone":60,"phoneExt":18,"email":61},"Rustem Ismagilov, PhD","626-395-8130","rustem.admin@caltech.edu",{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":49,"countryCode":50,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"The University of Chicago","RECRUITING","Chicago","Illinois","60637",{"type":52,"coordinates":69},[70,71],-87.65005,41.85003,{"lat":71,"lon":70},[74,76],{"name":30,"role":35,"phone":18,"phoneExt":18,"email":75},"bjabri@bsd.uchicago.edu",{"name":34,"role":35,"phone":18,"phoneExt":18,"email":37},{"facility":78,"status":64,"city":79,"state":80,"zip":81,"country":49,"countryCode":50,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Mayo Clinic","Rochester","Minnesota","55902",{"type":52,"coordinates":83},[84,85],-92.4699,44.02163,{"lat":85,"lon":84},[88,91],{"name":89,"role":35,"phone":18,"phoneExt":18,"email":90},"Joseph Murray, MD","Murray.Joseph@mayo.edu",{"name":92,"role":35,"phone":93,"phoneExt":18,"email":94},"Chadrick Hinson","507-266-0237","Hinson.chadrick@mayo.edu",{"type":96,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[98,101,102],{"name":99,"class":100},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",{"name":78,"class":6},{"name":44,"class":6},"100491506","tissue-destruction-and-healing-in-celiac-disease-100491506",false,"NCT05680012","Tissue Destruction and Healing in Celiac Disease","Inclusion Criteria:\n\nGluten challenge group:\n\n1. Age 18 to 75 years old\n2. Diagnosis of Celiac disease for at least 12 months by intestinal biopsy\n3. Follow a strict gluten-free diet for at least the 12 consecutive months\n\nGluten de-challenge group:\n\n1. Age 18 to 75 years old\n2. Showing typical celiac disease symptoms\n3. Not on a gluten-free diet\n\nControl group:\n\n1. Age 18 to 75 years old\n2. Females who are not pregnant\n\nExclusion Criteria:\n\nGluten challenge group:\n\n1. Diagnosis of any severe complication of celiac disease\n2. Diagnosis of other chronic, active GI disease\n3. Selective IgA deficiency\n4. Severe reaction to gluten exposure\n5. Any clinically significant diseases\n6. History of significant substance or alcohol abuse\n7. Pregnant or lactating\n8. Diagnosis of blood clotting disorders\n\nGluten de-challenge group:\n\n1. History of chronic inflammatory gastrointestinal disease\n2. Gastrointestinal illness within the 4-week period prior to screening\n3. History of lymphoproliferative disease\n4. Uncontrolled blood clotting disorders\n5. Any clinically significant diseases\n6. History of significant substance or alcohol abuse\n\nControl group:\n\n1. Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs\n2. Known intestinal inflammation\n3. Prior gastrointestinal surgery\n4. Taking of antiplatelet agents or anticoagulants\n5. Family history of celiac disease",true,"ALL","18 Years","75 Years",{"count":114,"type":115},220,"ESTIMATED","INTERVENTIONAL",[118],"NA","The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.",[121],"Celiac Disease",[123,124,125,126,127,128],"gluten-free diet","HLA-DQ2","HLA-DQ8","microbiome","metagenomics","intestinal epithelial cells","2026-05-07",{"date":131,"type":132},"2026-05-11","ACTUAL",{"date":134,"type":132},"2023-07-14",{"date":136,"type":115},"2027-06-30",{"name":5,"class":6},3]