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

ISRCTN	ISRCTN62040425
DOI	https://doi.org/10.1186/ISRCTN62040425
Protocol serial number	N/A
Sponsor	King's College London (UK)
Funder	King's College London (UK)

Submission date: 22/01/2010
Registration date: 08/03/2010
Last edited: 14/11/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kevin Whelan
Scientific

4.06 Franklin Wilkins Building
King's College London
150 Stamford St
London
SE1 9NH
United Kingdom

Study information

Primary study design	Interventional
Study design	Randomised controlled parallel group trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The effect of a low FODMAP diet on luminal microbiota, fermentation and symptoms: A randomised controlled trial
Study objectives	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(s)	Guy's Research Ethics Committee, 11/11/2009, ref: 09/H0804/89
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	31/12/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	40
Key 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
Key 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
Date of first enrolment	01/02/2010
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

4.06 Franklin Wilkins Building

London
SE1 9NH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes