Gluten-free Diet in Irritable Bowel Syndrome

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Gluten-free diet

• Registration Number: NCT02528929
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief 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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2015-08-18
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Primary Completion: 2018-07-31
• Study Completion: 2018-11-13
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Patients aged 16 years or over
2. Patients fulfilling ROME III symptom based criteria for IBS-D but do not have coeliac disease

Exclusion Criteria

1. Patients diagnosed with coeliac disease
2. Patients already on a gluten-free diet
3. Patients initially referred with self-reported gluten sensitivity
4. Patients with organic conditions that can mimic IBS-D such as idiopathic bile acid diarrhoea, pancreatic insufficiency, microscopic colitis, and inflammatory bowel disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
At-risk serology	Gluten-free diet	Gluten-free diet
Not at-risk serology	Gluten-free diet	Gluten-free diet

Primary Outcome Measures

Name	Time	Method
Irritable Bowel Syndrome Symptom Severity Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.	6 weeks
Fatigue Impact Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.	6 weeks
Short-form 36 Quality of Life Scores. This validated questionaire will be self-completed at baseline and at week 6. The investigators will compare the changes in scores over this time point.	6 weeks
Assess whether patients opt to continue with a GFD of their own volition	1-2 years	At the end of the six-week GFD trial period, patients will be asked whether or not they plan to continue with a GFD of their own volition. This will be assessed by a "yes/no" answer. Those who choose to do so will now be followed-up under routine clinical care over the next 1-2 years. This will allow the investigators to assess whether symptom-remission is maintained by using the same questionnaires mentioned in outcomes 1 to 4. It will also allow the investigators to monitor well-being in the form of body-mass index and serum haematinics (vitamin B12, folate, ferritin, albumin, haemoglobin).