In vitro and in vivo analysis of wheat varieties for non-immunogenicity to celiac disease patients.

Jasmine Grover0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.

发起方

Jasmine Grover