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

NCT ID: NCT04072991

Last Updated: 2023-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-18
• Study Completion Date: 2021-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low FODMAP diet

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

Group Type: ACTIVE_COMPARATOR

dietary therapy

Intervention Type: OTHER

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

Gluten Free Diet

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

Group Type: ACTIVE_COMPARATOR

dietary therapy

Intervention Type: OTHER

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

British Dietetic Association diet

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

Group Type: ACTIVE_COMPARATOR

dietary therapy

Intervention Type: OTHER

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

Interventions

dietary therapy

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

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Imran Aziz, MD

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Royal Hallamshire Hospital

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 35240330 (View on PubMed)

Other Identifiers

STH20655

Identifier Type: -

Identifier Source: org_study_id