None listed
Conditions
Brief summary
The purpose of this study is to confirm that gluten-containing foods causes abdominal symptoms and fatigue in people who do not have coeliac disease and to investigate if these individuals can tolerate a low-dose of gluten.
Interventions
Arm 1: Whole wheat-gluten (16 grams of commercial gluten per day); and Arm 2: Whole wheat-gluten (2 grams of commercial gluten per day ). The study is a randomised, placebo-controlled, double-blinded cross-over study design of 9 weeks duration (including a two-week run-in period at the start), where eligible volunteers will be randomly allocated to receive one of the three treatment arms for 1 week, followed by a washout period of at least 2-weeks (or until symptoms induced during the previous dietary challenge have resolved), before crossing over to the next diet. Each volunteer will undertake all 3 treatment arms. All food will be provided where the gluten will be administered across the day in different meals (all baseline meals will be gluten-free and low in poorly absorbed fermentable carbohydrates).
Sponsors
Study design
Eligibility
Inclusion criteria
1. Met Rome III criteria for Irritable Bowel Syndrome (IBS) prior to implementation of gluten-free diet (GFD) 2. Current gastrointestinal (GI) symptoms well-controlled on a GFD 3. Adherent to a strict GFD for the previous 6 weeks. 4. Coeliac disease excluded by either normal duodenal histology while consuming a gluten-containing diet or by having a genotype that is inconsistent with coeliac disease (Human Leukocyte Antigen (HLA) -DQ2 and -DQ8 negative)
Exclusion criteria
1. Other significant GI disease (e.g., cirrhosis, inflammatory bowel disease) or other clinically significant co-morbidity. 2. Intake of non-steroidal anti-inflammatory drugs 3. Use of systemic immunosuppressant medication (e.g., prednisolone, methotrexate, thiopurines, anti-tumour necrosis factor drugs) 4. Excessive alcohol intake 5. Poorly controlled psychiatric disease 6. Unable to give written/informed consent