Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 70 Years|
Inclusion Criteria:Gluten challenge group: 1. Age 18 to 70 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 70 years old. 2. Showing typical celiac disease symptoms. 3. Not on a gluten-free diet. Control group: 1. Age 18 to 70 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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Chicago|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Bana Jabri, MD|
|Principal Investigator Affiliation||University of Chicago|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Celiac disease is an autoimmune enteropathy characterized by chronic inflammation of the small intestinal mucosa triggered by gluten uptake that occurs in genetically susceptible individuals carrying the specific class II human leucocyte antigens (HLA) DQ2 and DQ8 alleles. There is a spectrum in intestinal tissue damage associated with celiac disease. Some individuals develop inflammatory immunity in the absence of tissue damage, while others experience tissue damage ranging from partial to total villous atrophy. Persistent mucosal damage is associated with several severe complications, including lymphoproliferative malignancy and bone diseases. In addition, individuals with active celiac disease display a wide range of clinical symptoms, including metabolic defects that are not correlated to the degree of villous atrophy. Although much progress has been made in understanding celiac disease, major gaps remain in understanding biological mechanisms underlying inter-individual differences in clinical presentations and capacity to heal while maintaining a gluten-free diet.
Experimental: Gluten challenge group
Diagnosis of celiac disease by intestinal biopsy and serology for at least 12 months
No Intervention: Gluten de-challenge group
Suspected celiac disease either showing typical symptoms or positive celiac disease serology
No Intervention: Control group
No history or symptoms of celiac disease
Dietary Supplement: - Gluten containing snack bar
Ingest snack bars containing 3 grams of gluten every day for 7 weeks.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.