The effect of a low FODMAP diet on luminal microbiota, fermentation and symptoms

Completed

Conditions: Irritable bowel syndrome
Digestive System

Registration Number: ISRCTN62040425

Lead Sponsor: King's College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patients will be recruited from Gastrointestinal and Dietetic Outpatient clinics at Guy?s and St Thomas? NHS Foundation Trust, London, UK.
1. Adult patients aged 18-65 years
2. Identified as having IBS based on Rome III criteria
3. Symptoms including bloating and/or diarrhoea

Exclusion Criteria

1. Patients with any other gastrointestinal disease or gastrointestinal surgery
2. Patients whose major IBS symptom is constipation
3. Patients receiving lactulose or any other probiotic or prebiotic substances in the four weeks prior to the study
4. Patients who have taken antibiotics in the 4 weeks prior to the study
5. Patients who have received bowel preparation for investigative procedures in the 4 weeks prior to the study
6. Patients with any other significant major organ disorders, including diabetes, psychiatric and current eating disorders
7. Patients who report to be pregnant or lactating
8. Patients who have had changes to IBS medications or dose in the 4 weeks prior to the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the effect of a low FODMAP diet on faecal microbiota in patients with IBS.<br>Faecal samples will be collected at baseline and at 4 weeks.

Secondary Outcome Measures

Name	Time	Method
1. To assess the effect of a low FODMAP diet on faecal Short Chain Fatty Acid (SCFA), pH and faecal water in patients with IBS.<br>2. To assess the effect of a low FODMAP diet on symptoms in patients with IBS.<br>3. To assess the effect of a low FODMAP diet on stool consistency and frequency in patients with IBS.<br>4. To assess the nutritional adequacy of a low FODMAP diet in patients with IBS.<br>5. To assess the acceptability of a low FODMAP diet in IBS patients.<br>6. Weight and height.<br>Outcomes will be assessed at baseline and at 4 weeks. Patients will keep a symptom diary and diet diary, and 2 questionnaires will be used to assess nutritional adequacy, FODMAP intake and diet acceptability.