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

NCT04072991 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-04-12

No results posted yet for this study

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

Interventions

OTHER

dietary therapy

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

Sponsors & Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Imran Aziz, MD · Sheffield Teaching Hospitals NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-18
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04072991 on ClinicalTrials.gov