Gluten-free Diet in Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Gluten-free diet
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility Criteria
Inclusion Criteria:
- Patients aged 16 years or over
- Patients fulfilling ROME III symptom based criteria for IBS-D but do not have coeliac disease
Exclusion Criteria:
- Patients diagnosed with coeliac disease
- Patients already on a gluten-free diet
- Patients initially referred with self-reported gluten sensitivity
- Patients with organic conditions that can mimic IBS-D such as idiopathic bile acid diarrhoea, pancreatic insufficiency, microscopic colitis, and inflammatory bowel disease
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
At-risk serology
Not at-risk serology
Arm Description
Gluten-free diet
Gluten-free diet
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Assess whether patients opt to continue with a GFD of their own volition
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).
Full Information
NCT ID
NCT02528929
First Posted
August 18, 2015
Last Updated
April 2, 2019
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02528929
Brief Title
Gluten-free Diet in Irritable Bowel Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 31, 2018 (Actual)
Study Completion Date
November 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
At-risk serology
Arm Type
Active Comparator
Arm Description
Gluten-free diet
Arm Title
Not at-risk serology
Arm Type
Active Comparator
Arm Description
Gluten-free diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Gluten-free diet
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
Title
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
Title
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
Title
Assess whether patients opt to continue with a GFD of their own volition
Description
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).
Time Frame
1-2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 16 years or over
Patients fulfilling ROME III symptom based criteria for IBS-D but do not have coeliac disease
Exclusion Criteria:
Patients diagnosed with coeliac disease
Patients already on a gluten-free diet
Patients initially referred with self-reported gluten sensitivity
Patients with organic conditions that can mimic IBS-D such as idiopathic bile acid diarrhoea, pancreatic insufficiency, microscopic colitis, and inflammatory bowel disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Sanders
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26748221
Citation
Aziz I, Trott N, Briggs R, North JR, Hadjivassiliou M, Sanders DS. Efficacy of a Gluten-Free Diet in Subjects With Irritable Bowel Syndrome-Diarrhea Unaware of Their HLA-DQ2/8 Genotype. Clin Gastroenterol Hepatol. 2016 May;14(5):696-703.e1. doi: 10.1016/j.cgh.2015.12.031. Epub 2015 Dec 31.
Results Reference
derived
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Gluten-free Diet in Irritable Bowel Syndrome
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