E-C DIBS: Randomised Controlled Study: Comparing the Effectiveness and Convenience of Dietary Therapy for Irritable Bowel Syndrome (IBS)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Percentage with at least 50-point reduction in Irritable bowel syndrome Severity Scoring System questionnaire
Study Overview
Brief Summary
Irritable bowel syndrome is a functional lower gastrointestinal disorder characterised by abdominal pain and altered bowel habit in the absence of organic pathology to explain the symptoms. Irritable bowel syndrome has a prevalence of approximately 10% in adults, shows a female preponderance, and is more common in younger individuals. In clinical practice, Irritable bowel syndrome accounts for almost a third of all gastroenterology cases seen in primary care, with a subsequent third of these being referred onto secondary-care for further evaluation. The economic burden of Irritable bowel syndrome, in terms of medical expense, work absenteeism and loss of productivity, is considerable.
The exact cause of irritable bowel syndrome is unknown. Accordingly there has been a huge surge in interest for dietary therapies to help manage Irritable bowel syndrome. To date, there are only a handful of small randomized controlled trials evaluating the efficacy of dietary therapy in Irritable bowel syndrome. In light of this we plan to conduct the first randomized controlled trial directly comparing the effectiveness of the low-FODMAP diet, British Dietetic Association diet, and the gluten free diet in Irritable bowel syndrome. Moreover, such a trial allows for a direct comparison of nutritional and gut microbial changes, both of which can suffer detrimental consequences following the implementation of restrictive dietary therapies. This study is also unique in that it takes into consideration the patients' perspective with regards to the convenience and cost-effectiveness of implementing such diets into routine day-to-day life. The study will aim to recruit 100 patients from Sheffield Teaching Hospitals gastrointestinal clinics. Following recruitment patients will be seen by a hospital dietitian where they will be randomized to one of the 3 diets. Participants will complete a questionnaire portfolio weekly for one month as part of the study
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Irritable Bowel syndrome - as defined by abdominal pain and altered bowel habit in the absence of organic pathology to explain the symptoms.This is the contemporary definition as provided by the Rome IV committee.
- •Age 18-65 years
- •English literate
- •Can travel to hospital
- •Telephone/internet access
Exclusion Criteria
- •Inflammatory bowel disease
- •Coeliac disease
- •Gastrointestinal cancer
- •Previous abdominal surgery
- •Scleroderma
- •Poorly controlled diabetes
- •Severe liver disease
- •Severe renal disease
- •Severe respiratory disease
- •Severe cardiac disease
- •Severe psychiatric disease
- •Memory disorders
- •Current dietary interventions
- •Recent/current use of Probiotics
- •Recent/current use of Antibiotics
- •Recent/current use of Narcotics
- •Currently titrated antidepressants (i.e. not on a stable dose)
Arms & Interventions
Low FODMAP diet
As part of their treatment for IBS participants may be randomised to a low FODMAP diet
Intervention: dietary therapy (Other)
Gluten Free Diet
As part of their treatment for IBS participants may be randomised to a gluten free diet
Intervention: dietary therapy (Other)
British Dietetic Association diet
As part of their treatment for IBS participants may be randomised to the BDA diet
Intervention: dietary therapy (Other)
Outcomes
Primary Outcomes
Percentage with at least 50-point reduction in Irritable bowel syndrome Severity Scoring System questionnaire
Time Frame: Baseline to week 4
A validated questionnaire to assess IBS symptoms and severity. The ranges of this questionnaire are included below: How severe was your pain? 0 (no pain) -100 (very severe) how severe is your abdominal (tummy) pain? 0 (no pain) - 100 (very severe) how severe is your abdominal distention/tightness? 0 (no pain) - 100 (very severe) How satisfied are you with your bowel habit? 0 (very happy) - 100 (very unhappy) Please indicate with a cross on the line below how much your irritable bowel syndrome is affecting or interfering with your life in general. 0 (not at all) - 100 (completely) A higher score on any scale represents a negative outcome. A ≥ 50-point reduction in IBS-SSS following intervention represents a clinically significant improvement
Secondary Outcomes
- Comprehensive Nutrition Assessment Questionnaire(Baseline to week 4)
- Changes in somatization(Baseline to week 4)
- Changes in IBS-quality of life(Baseline to week 4)
- Changes in proportion with anxiety and depression(Baseline to week 4)
- Acceptability of dietary restriction(Week 4)
- Food related quality of life (QOL) questionnaire(Week 4)
- Changes in stool dysbiosis index(Baseline to week 4)