A Study Comparing the Effectiveness and Convenience of Dietary Therapy for Irritable Bowel Syndrome (IBS)

NCT04072991 | Completed

• 1 other identifier: STH20655
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage with at least 50-point reduction in Irritable bowel syndrome Severity Scoring System questionnaire

  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

  Baseline to week 4

Secondary Outcomes (7)

• Changes in proportion with anxiety and depression

  Baseline to week 4

• Changes in somatization

  Baseline to week 4

• Changes in IBS-quality of life

  Baseline to week 4

• Acceptability of dietary restriction

  Week 4

• Food related quality of life (QOL) questionnaire

  Week 4

Study Arms (3)

Low FODMAP diet

ACTIVE COMPARATOR

As part of their treatment for IBS participants may be randomised to a low FODMAP diet

Other: dietary therapy

Gluten Free Diet

ACTIVE COMPARATOR

As part of their treatment for IBS participants may be randomised to a gluten free diet

Other: dietary therapy

British Dietetic Association diet

ACTIVE COMPARATOR

As part of their treatment for IBS participants may be randomised to the BDA diet

Other: dietary therapy

Interventions

dietary therapy OTHER

participants will undertake a four week diet as part of their IBS treatment

British Dietetic Association diet; Gluten Free Diet; Low FODMAP diet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnant
• Current dietary interventions
• Recent/current use of Probiotics

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35240330 DERIVED

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Imran Aziz, MD

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: August 28, 2019
• Study Start: April 18, 2019
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)