Health Condition 1: null- celiac disease Health Condition 2: K638- Other specified diseases of intestine
Conditions
Interventions
Intervention1: Least Immunogenic Wheat Variety: After in vitro analysis, the least immunogenic variety of wheat will be administered to patients of celiac disease in remission to look for safety of th
Sponsors
Jasmine Grover
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Signed informed consent. 2. History of biopsy proven celiac disease. 3. Adherence to gluten free diet for at least 2 years prior to randomization. 4. tTG antibody negative at screening for those on gluten free diet. 5. Willing to consume a large meal each day, adhere to a 7 months long gluten challenge and undergo at least two on-study upper gastrointestinal endoscopies including multiple biopsies.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Active dermatitis herpetiformis lesions at the time of screening. 2. Any clinical contraindication to performing an endoscopy with intestinal biopsy. 3. Taking any oral probiotic supplements 6 months prior to entry. 4. Use of any immunosuppressive medications 6 months prior to entry. 5. History of alcohol abuse or illicit drug use within past 12 months. 6. Current untreated or active peptic ulcer disease, IBS or IBD. 7. The existence of any uncontrolled chronic disease or condition (for example HIV-AIDS, hepatitis, type 1 or 2 diabetes or cancer) 8. Uncontrolled complications of celiac disease. 9. Known allergy or hypersensitivity to any of the components to be used in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to find a noxious/ less immunogenic wheat variety for celiac disease patientsTimepoint: 7 months | — |
Secondary
| Measure | Time frame |
|---|---|
| to analyze if modern wheat varieties are a cause of increasing prevalence of celiac diseaseTimepoint: 15 days-2 months | — |
Countries
India
Contacts
Public ContactJasmine Grover
Dayanand Medical College and Hospital
Outcome results
None listed