Dietary interventions for irritable bowel syndrome

Not Applicable

Completed

• Conditions: Irritable bowel syndrome; Digestive System

• Registration Number: ISRCTN02275221
• Lead Sponsor: King's College London (UK)

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28993261 2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28625832 2020 results in https://pubmed.ncbi.nlm.nih.gov/33183883/ (added 16/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-28
• Study Completion: 2014-09-30
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

1. Men and women aged 18-65 years with IBS-D, IBS-M or unsubtyped IBS based on Rome III criteria who do not have a major medical condition (diabetes, psychiatric or current eating disorders)
2. Gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease)
3. History of previous GI surgery, except cholecystectomy and haemorrhoidectomy

Exclusion Criteria

1. Females who report to be pregnant or lactating
2. Consumption of antibiotics, pre or probiotics (in food products or as supplements) in the last 4 weeks prior to, or during the study
3. Use of unpermitted medications (e.g. biological therapies)
4. Patients who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
5. Patients who have had changes to IBS medications or dose in the 4 weeks prior to the study
6. Abdominal pain or discomfort for less than 2 days in the screening week, the frequency threshold recommended for clinical trials. Exclusion of those with minimal symptoms is recommended, and only those that experience pain on at least two days will be included.
7. Individuals with additional specific dietary needs

Study & Design

• Study Type: Interventional
• Study Design: Not specified