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Not Yet Recruiting NCT05680012

Tissue Destruction and Healing in Celiac Disease

Conditions: Celiac Disease

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 220
Sponsor: University of Chicago

Location: United States

Summary

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.

Eligibility Criteria

Inclusion Criteria:Gluten challenge group:Age 18 to 70 years oldDiagnosis of Celiac disease for at least 12 months by intestinal biopsyFollow a strict gluten-free diet for at least the 12 consecutive monthsGluten de-challenge group:Age 18 to 70 years oldShowing typical celiac disease symptomsNot on a gluten-free dietControl group:Age 18 to 70 years oldFemales who are not pregnantExclusion Criteria:Gluten challenge group:Diagnosis of any severe complication of celiac diseaseDiagnosis of other chronic, active GI diseaseSelective IgA deficiencySevere reaction to gluten exposureAny clinically significant diseasesHistory of significant substance or alcohol abusePregnant or lactatingDiagnosis of blood clotting disordersGluten de-challenge group:History of chronic inflammatory gastrointestinal diseaseGastrointestinal illness within the 4-week period prior to screeningHistory of lymphoproliferative diseaseUncontrolled blood clotting disordersAny clinically significant diseasesHistory of significant substance or alcohol abuseControl group:Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugsKnown intestinal inflammationPrior gastrointestinal surgeryTaking of antiplatelet agents or anticoagulantsFamily history of celiac disease

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05680012). StuddyBuddy aggregates publicly available trial information.