The role of gluten as a cause of gastrointestinal symptoms and fatigue in patients who do not have coeliac disease

Completed

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

• Registration Number: ACTRN12610000524099
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The comparison of the change in mean in the overall symptom score measured on the visual analogue scale.[After 1 week of each study diet.]