Clinical Trials Directory

Trials / Completed

CompletedNCT02528929

Gluten-free Diet in Irritable Bowel Syndrome

Assessing the Clinical Response to a Gluten Free Diet in Patients With Diarrhoea Predominant Irritable Bowel Syndrome, in Whom Overt Coeliac Disease Has Been Excluded

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
48 (actual)
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

To evaluate the effects of a gluten-free diet in irritable bowel syndrome.

Detailed description

Irritable bowel syndrome with diarrhoea (IBS-D) is commonly encountered in primary and secondary-care practice. There are various triggers including diet. There is a growing number of people taking a gluten-free diet (GFD) of their own volition even in the absence of coeliac disease (CD). The investigators aim to assess whether a GFD could be of benefit to patients with IBS-D, previously naive to the effects of gluten and in whom CD has been excluded as per normal duodenal biopsies. The investigators will also assess whether certain factors may predict a clinical responder such as the presence or absence of at-risk coeliac serology.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTGluten-free dietPatients with IBS-D will commence a gluten-free diet for 6 weeks following dietetic input. They will be informed they do not have coeliac disease. They will however be blinded to whether or not they have any markers of at-risk serology. They will self-complete validated questionnaires over 6 weeks. Any subjects who opt to continue with a gluten-free diet thereafter of their own volition will be kept under observation as per routine clinical care.

Timeline

Start date
2012-09-01
Primary completion
2018-07-31
Completion
2018-11-13
First posted
2015-08-19
Last updated
2019-04-04

Source: ClinicalTrials.gov record NCT02528929. Inclusion in this directory is not an endorsement.