Effect of low gluten doses in patients suspected of having nonceliac gluten sensitivity (NCGS): a randomized, double-blind, placebo-controlled cross-over gluten challenge trial

St. Matteo Hospital Foundation (Italy)0 个研究点目标入组 58 人开始时间: 2014年7月31日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Adult patients referred to our outpatients? clinics because of persistence of relevant intestinal and extraintestinal symptoms believed by them to be caused by the ingestion of food containing even low doses of gluten.
•2. Under gluten-containing diet at the time of screening since at least two months
•3. Happy to undergo ad hoc screening, including:
•3.a. Serum determination of IgA anti-transglutaminase and anti-endomysial antibodies
•3.b. IgG anti-gliadin antibodies (AGA)
•3.c. Total IgA and IgE
•3.d. Wheat-specific IgE
•3.e. Upper endoscopy with collection of multiple duodenal biopsies
•3.f. HLA genotyping
•3.g. Fecal calprotectin
•3.h. Lactose breath test

•1. Other significant gastrointestinal diseases, such as inflammatory bowel disease or cirrhosis,
•2. Other clinically significant comorbidities such as diabetes, use of nonsteroidal anti-inflammatory agents or systemic immunomodulators
•3. Pregnancy
•4. Inability to give written informed consent
•5. Reported psychiatric disorder
•6. Excessive alcohol intake
•Only patients, who at the end of the screening are found not to be affected by celiac disease, wheat allergy, lactose or FODMAP intolerance, Helicobacter pylori infection, giardiasis, and who complain of relevant gluten-dependent symptoms that is affecting the overall quality of life, will be randomized according to a computer-generated list of random numbers held by an independent observer to either the gluten or the placebo treatment group.

发起方

St. Matteo Hospital Foundation (Italy)