Dietary interventions for irritable bowel syndrome

• Register: ISRCTN
• Last refreshed on: 30 November 2020
• Main ID: ISRCTN02275221
• Date of registration: 28/08/2012
• Prospective Registration: Yes
• Primary sponsor: King's College London (UK)
• Public title: Dietary interventions for irritable bowel syndrome
• Scientific title: The impact of dietary interventions for irritable bowel syndrome on luminal microbiota, symptoms, nutrient intake and quality of life: a randomised controlled trial
• Date of first enrolment: 01/09/2012
• Target sample size: 100
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN02275221
• Study type: Interventional
• Study design: 2 x 2 factorial design randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Heidi Staudacher

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Irritable bowel syndrome
Digestive System
Irritable bowel syndrome

Intervention(s)

Current interventions as of 24/01/2013:
4-week treatment diet + placebo
4-week treatment diet + added probiotic
4-week week sham diet + placebo
4-week sham diet + added probiotic

Previous interventions until 24/01/2013:
4-week fermentable carbohydrate restriction + placebo
4-week fermentable carbohydrate restriction + added probiotic
4-week week sham diet + placebo
4-week sham diet + added probiotic

Primary Outcome(s)

1. Luminal bifidobacteria concentration between groups at 4 weeks

Added 05/08/2014:
2. Proportion of participants with adequate relief of IBS symptoms at 4 weeks

Secondary Outcome(s)

1. Difference in total and individual luminal gastrointestinal microbiota at 4 weeks
2. Difference in faecal short chain fatty acids and pH between groups at 4 weeks
3. Difference in IBS symptoms between groups at 4 weeks
4. Difference in stool consistency between groups at 4 weeks
5. Difference in nutrient intake between groups at 4 weeks
6. Difference in quality of life (QOL) scores between groups at 4 weeks

Secondary ID(s)

N/A

Source(s) of Monetary Support

National Institute for Health Research

Ethics review

Status:
Approval date:
Contact:

NRES Committee London-Fulham, 08/10/2012, ethics no. 12/LO/1402

Results

• Results available: Yes
• Date Completed: 30/09/2014