A Double-Blind, Placebo-Controlled, Adaptive Dose-Response Study To Assess the Acute Effects of Gluten in Adults with Treated Coeliac Disease (Gluten Threshold Study”)

Wesley Medical Research0 个研究点目标入组 51 人开始时间: 2021年6月22日最近更新: 2022年6月27日

研究概览

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•1. Adults 25 to 75 years of age (inclusive) who have signed an informed consent form.
•2. A history of Coeliac disease diagnosed on the basis of duodenal biopsy showing villous atrophy and abnormal coeliac disease-specific serology (anti-transglutaminase 2 IgA, deamidated gliadin peptide IgG, or anti-endomysial IgA.
•3. Initiated gluten-free diet at least 2 years prior to screening.
•4. No known gluten exposure within the previous one month at screening
•5. No known allergy to gluten.
•6. Willingness to consume up to 1 g of gluten (equivalent to about 1/2 slice of standard bread) at one time.
•7. Willingness to undergo study procedures.
•8. Able to read and understand English.

•1. Symptoms of fever, cough, shortness of breath, or suspicion of COVID-19 infection.
•2. Known consumption of gluten-containing food within the previous one month.
•3. Any medical condition or an immune-suppressing medical treatment taken within the previous 3 months that in the opinion of the investigator would impact the immune response (other than coeliac disease), confound interpretation of study results, or pose an increased risk to the patient. Topical or inhaled corticosteroids are acceptable.
•4. Females who are pregnant, including those with positive urinary pregnancy test on the first day of screening.
•5. Positive at Screening for both TGA and DGP-G serology tests, but note that elevation of one serology test is not an exclusion.

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