The role of gluten on gastrointestinal symptoms and mental health in people with non-coeliac gluten sensitivity.

Completed

• Conditions: on-coeliac gluten sensitivity; Non-coeliac gluten sensitivity; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12613000768796
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Aged >16 years of age, met Rome III criteria for IBS prior to implementation of a GFD, had currently well controlled gastrointestinal symptoms, and had been adherent to a GFD for at least the preceding six weeks. Celiac disease was excluded by either a normal duodenal biopsy (Marsh 0) performed at endoscopy while on a gluten containing diet and/or by the absence of the HLA-DQ2 and HLA-DQ8 haplotype.

Exclusion Criteria

Other significant gastrointestinal disease (such as cirrhosis or inflammatory bowel disease); other clinically significant co-morbidity; intake of non-steroidal anti-inflammatory agents; use of systemic immunosuppressant medication; poorly controlled psychiatric disease; excessive alcohol intake; pregnancy; or inability to give written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified