Overview

This trial is active, not recruiting.

Condition irritable bowel syndrome
Treatment gluten-free diet
Sponsor Sheffield Teaching Hospitals NHS Foundation Trust
Start date September 2012
End date August 2015
Trial size 48 participants
Trial identifier NCT02528929, STH16497

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Gluten-free diet
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.
(Active Comparator)
Gluten-free diet
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.

Primary Outcomes

Measure
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.
time frame: 6 weeks

Secondary Outcomes

Measure
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.
time frame: 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.
time frame: 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.
time frame: 6 weeks
Assess whether patients opt to continue with a GFD of their own volition
time frame: 1-2 years

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title 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
Principal investigator David Sanders
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Sheffield Teaching Hospitals NHS Foundation Trust.