Dietary interventions in irritable bowel syndrome

Not Applicable

Completed

• Conditions: Irritable bowel syndrome; Digestive System

• Registration Number: ISRCTN16562415
• Lead Sponsor: King's College London

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32433273/ results (added 07/08/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-23
• Study Completion: 2017-03-31
• Last Update Posted: 20 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

1. Men and women aged 18-65 years with diarrhoea-predominant IBS (IBS-D), mixed-type IBS (IBS-M) or unsubtyped IBS (IBS-U) based on Rome III criteria who do not have a major medical condition (diabetes, psychiatric or current eating disorders), gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease) or history of previous GI surgery, except cholecystectomy and haemorrhoidectomy
2. Individuals able to give informed consent
3. Individuals naive to the dietary intervention

Exclusion Criteria

1. Females who report to be pregnant or lactating
2. Consumption of antibiotics, prebiotics or probiotics (in food products or as supplements) in the last 4 weeks prior to, or during the study
3. Use of unpermitted medications
4. Participants who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
5. Participants who have had changes to IBS medications or dose in the 4 weeks prior to the study
6. Less than 2 days of at least moderate abdominal pain or discomfort in the screening week
7. Individuals with additional specific dietary needs
8. Individuals with excess alcohol or caffeine intake as assessed by diet questionnaires as these substances may confound symptom results

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Luminal bifidobacteria concentration between groups at 4 weeks<br> 2. Adequate symptom relief between groups at 4 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Difference in IBS symptoms between the three groups at 4-weeks.<br> 2. Difference in stool consistency and stool frequency between three groups at 4-weeks<br> 3. Difference in total and individual luminal gastrointestinal microbiota between the three groups at 4-weeks<br> 4. Difference in faecal short chain fatty acids and pH between the three groups at 4-weeks<br> 5. Differences in urine metabolomics between the three groups at 4-weeks<br> 6. Difference in nutrient intake between dietary interventions at 4-weeks<br> 7. Difference in QOL scores between the three groups at 4-weeks<br> 8. Patient acceptability of the diet and food supplement (questionnaire)<br>