Condition category
Digestive System
Date applied
22/01/2010
Date assigned
08/03/2010
Last edited
14/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kevin Whelan

ORCID ID

Contact details

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

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 measures

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

Eligibility

Participant 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

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

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Hodgkin Building
Guy's Campus Kings College London
LondonSE1 1UL
UNITED KINGDOM
London
SE1 1UL
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22739368

Publication citations

  1. 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.

Additional files

Editorial Notes