Clinical trial NCT04072991: A Study Comparing the Effectiveness and Convenience of Dietary Therapy for Irritable Bowel Syndrome (IBS)
Official title: E-C DIBS: Randomised Controlled Study: Comparing the Effectiveness and Convenience of Dietary Therapy for Irritable Bowel Syndrome (IBS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Age 18-65 years
3. English literate
4. Can travel to hospital
5. Telephone/internet access

Exclusion Criteria:

1. Inflammatory bowel disease
2. Coeliac disease
3. Gastrointestinal cancer
4. Previous abdominal surgery
5. Scleroderma
6. Poorly controlled diabetes
7. Severe liver disease
8. Severe renal disease
9. Severe respiratory disease
10. Severe cardiac disease
11. Severe psychiatric disease
12. Memory disorders
13. Pregnant
14. Current dietary interventions
15. Recent/current use of Probiotics
16. Recent/current use of Antibiotics
17. Recent/current use of Narcotics
18. Currently titrated antidepressants (i.e. not on a stable dose)

Primary outcomes:
measure: Percentage with at least 50-point reduction in Irritable bowel syndrome Severity Scoring System questionnaire
timeFrame: Baseline to week 4
Secondary outcomes:
measure: Changes in proportion with anxiety and depression
timeFrame: Baseline to week 4
measure: Changes in somatization
timeFrame: Baseline to week 4
measure: Changes in IBS-quality of life
timeFrame: Baseline to week 4
measure: Acceptability of dietary restriction
timeFrame: Week 4
measure: Food related quality of life (QOL) questionnaire
timeFrame: Week 4
measure: Comprehensive Nutrition Assessment Questionnaire
timeFrame: Baseline to week 4
measure: Changes in stool dysbiosis index
timeFrame: Baseline to week 4
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
state: South Yorkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Imran Aziz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rej A, Sanders DS, Shaw CC, Buckle R, Trott N, Agrawal A, Aziz I. Efficacy and Acceptability of Dietary Therapies in Non-Constipated Irritable Bowel Syndrome: A Randomized Trial of Traditional Dietary Advice, the Low FODMAP Diet, and the Gluten-Free Diet. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2876-2887.e15. doi: 10.1016/j.cgh.2022.02.045. Epub 2022 Feb 28.