Irritable bowel syndrome Digestive System Irritable bowel syndrome
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time 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
| Measure | Time 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