Irritable Bowel Syndrome
Conditions
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.
Interventions
DIETARY_SUPPLEMENTGluten-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.
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Outcome results
None listed