The effect of a low FODMAP diet on luminal microbiota, fermentation and symptoms
| ISRCTN | ISRCTN62040425 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62040425 |
| Secondary identifying numbers | N/A |
- 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
Scientific
4.06 Franklin Wilkins Building
King's College London
150 Stamford St
London
SE1 9NH
United Kingdom
Study information
| Study design | Randomised controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/02/2010 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
4.06 Franklin Wilkins Building
London
SE1 9NH
United Kingdom
SE1 9NH
United Kingdom
Sponsor information
King's College London (UK)
University/education
University/education
Hodgkin Building
Guy's Campus Kings College London
LondonSE1 1UL
UNITED KINGDOM
London
SE1 1UL
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
University/education
King's College London (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
