RECRUITINGINTERVENTIONAL
Tissue Destruction and Healing in Celiac Disease
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
Gluten challenge group:
1. Age 18 to 75 years old
2. Diagnosis of Celiac disease for at least 12 months by intestinal biopsy
3. Follow a strict gluten-free diet for at least the 12 consecutive months
Gluten de-challenge group:
1. Age 18 to 75 years old
2. Showing typical celiac disease symptoms
3. Not on a gluten-free diet
Control group:
1. Age 18 to 75 years old
2. Females who are not pregnant
Who Should NOT Join This Trial:
Gluten challenge group:
1. Diagnosis of any severe complication of celiac disease
2. Diagnosis of other chronic, active GI disease
3. Selective IgA deficiency
4. Severe reaction to gluten exposure
5. Any clinically significant diseases
6. History of significant substance or alcohol abuse
7. Pregnant or lactating
8. Diagnosis of blood clotting disorders
Gluten de-challenge group:
1. History of chronic inflammatory gastrointestinal disease
2. Gastrointestinal illness within the 4-week period prior to screening
3. History of lymphoproliferative disease
4. Uncontrolled blood clotting disorders
5. Any clinically significant diseases
6. History of significant substance or alcohol abuse
Control group:
1. Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs
2. Known intestinal inflammation
3. Prior gastrointestinal surgery
4. Taking of antiplatelet agents or anticoagulants
5. Family history of celiac disease
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
Gluten challenge group:
1. Age 18 to 75 years old
2. Diagnosis of Celiac disease for at least 12 months by intestinal biopsy
3. Follow a strict gluten-free diet for at least the 12 consecutive months
Gluten de-challenge group:
1. Age 18 to 75 years old
2. Showing typical celiac disease symptoms
3. Not on a gluten-free diet
Control group:
1. Age 18 to 75 years old
2. Females who are not pregnant
Exclusion Criteria:
Gluten challenge group:
1. Diagnosis of any severe complication of celiac disease
2. Diagnosis of other chronic, active GI disease
3. Selective IgA deficiency
4. Severe reaction to gluten exposure
5. Any clinically significant diseases
6. History of significant substance or alcohol abuse
7. Pregnant or lactating
8. Diagnosis of blood clotting disorders
Gluten de-challenge group:
1. History of chronic inflammatory gastrointestinal disease
2. Gastrointestinal illness within the 4-week period prior to screening
3. History of lymphoproliferative disease
4. Uncontrolled blood clotting disorders
5. Any clinically significant diseases
6. History of significant substance or alcohol abuse
Control group:
1. Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs
2. Known intestinal inflammation
3. Prior gastrointestinal surgery
4. Taking of antiplatelet agents or anticoagulants
5. Family history of celiac disease
Treatments Being Tested
DIETARY_SUPPLEMENT
Gluten containing snack bar
Ingest snack bars containing 3 grams of gluten every day for 6 weeks.
Locations (3)
California Institute of Technology
Pasadena, California, United States
The University of Chicago
Chicago, Illinois, United States
Mayo Clinic
Rochester, Minnesota, United States