An initiative to find a less toxic/ safe wheat variety for celiac disease patients
- Conditions
- Health Condition 1: null- celiac diseaseHealth Condition 2: K638- Other specified diseases of intestine
- Registration Number
- CTRI/2018/06/014521
- Lead Sponsor
- Jasmine Grover
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to find a noxious/ less immunogenic wheat variety for celiac disease patientsTimepoint: 7 months
- Secondary Outcome Measures
Name Time Method to analyze if modern wheat varieties are a cause of increasing prevalence of celiac diseaseTimepoint: 15 days-2 months