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Dietary interventions for irritable bowel syndrome

The impact of dietary interventions for irritable bowel syndrome on luminal microbiota, symptoms, nutrient intake and quality of life: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN02275221
Enrollment
100
Registered
2012-08-28
Start date
2012-09-01
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable bowel syndrome Digestive System Irritable bowel syndrome

Interventions

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

Sponsors

King's College London (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026