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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Gluten-free diet | Patients 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.