Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effect of a low FODMAP diet on luminal microbiota, fermentation and symptoms: A randomised controlled trial
Acronym
Study hypothesis
H0: there will be no significant difference in the concentration of faecal bifidobacteria in patients with Irritable Bowel Syndrome (IBS) following a low FODMAP diet (intervention) compared with those following a normal diet (control) for four weeks.
H1: there will be a significant difference in the concentration of faecal bifidobacteria in patients with IBS following a low Fermentable Oligo-, Di-, and Monosaccharides and Polyol (FODMAP) diet (intervention) compared with those following a normal diet (control) for four weeks.
Ethics approval
Guy's Research Ethics Committee, 11/11/2009, ref: 09/H0804/89
Study design
Randomised controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
Irritable bowel syndrome
Intervention
4-week low FODMAP diet compared to usual diet.
Patients in the intervention group will receive individualised dietary advice. A low FODMAP diet is a diet low in poorly absorbed fermentable carbohydrates. Patients will follow the diet for 4 weeks. The total duration of the study will be 5 weeks.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
To assess the effect of a low FODMAP diet on faecal microbiota in patients with IBS.
Faecal samples will be collected at baseline and at 4 weeks.
Secondary outcome measures
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.
2. To assess the effect of a low FODMAP diet on symptoms in patients with IBS.
3. To assess the effect of a low FODMAP diet on stool consistency and frequency in patients with IBS.
4. To assess the nutritional adequacy of a low FODMAP diet in patients with IBS.
5. To assess the acceptability of a low FODMAP diet in IBS patients.
6. Weight and height.
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.
Overall trial start date
01/02/2010
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients will be recruited from Gastrointestinal and Dietetic Outpatient clinics at Guys 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/02/2010
Recruitment end date
31/12/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
4.06 Franklin Wilkins Building
London
SE1 9NH
United Kingdom
Funders
Funder type
University/education
Funder name
King's College London (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22739368
Publication citations
-
Results
Staudacher HM, Lomer MC, Anderson JL, Barrett JS, Muir JG, Irving PM, Whelan K, Fermentable carbohydrate restriction reduces luminal bifidobacteria and gastrointestinal symptoms in patients with irritable bowel syndrome., J. Nutr., 2012, 142, 8, 1510-1518, doi: 10.3945/jn.112.159285.