Dietary interventions for irritable bowel syndrome
| ISRCTN | ISRCTN02275221 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02275221 |
| Secondary identifying numbers | N/A |
- Submission date
- 27/06/2012
- Registration date
- 28/08/2012
- Last edited
- 16/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Irritable bowel syndrome (IBS) is a digestive disorder that affects up to 15% of the population. Symptoms include stomach pain, bloating and altered bowel habit. It can be very debilitating and has a great impact on quality of life. A diet with an altered amount of carbohydrates (e.g. the types of fruits and vegetables) might be effective for symptoms such as bloating, stomach pain and flatulence for many people with IBS. Recent research has shown that the diet described above can impact on the amount of bifidobacteria in the bowel. Probiotics are friendly bacteria added to foods that can increase the amount of bifidobacteria in the bowel. This study will investigate the effect of this diet with a probiotic food supplement on:
1. Bacteria in the bowel and the products of bacterial fermentation
2. Gut symptoms (e.g. wind, bloating)
3. Stool frequency and consistency
4. Dietary intake
5. Quality of life
The effect of dietary change on symptoms and the bacteria in the bowel in the longer term will also be studied.
Who can participate?
Patients of Guy's and St Thomas' NHS Foundation Trust or St George's Healthcare Trust aged 18-65 with IBS
What does the study involve?
The study incorporates three study centre visits, one before the 4-week study period, one after the 4-week study period and one visit at 12 months. There may also need to be one initial visit prior to the baseline visit in order to obtain consent if the patient is not identified in clinic, but screened from the referral letter.
What are the possible benefits and risks of participating?
There are no anticipated risks to participants; however, changes to dietary intake will be required for a 4-week period. Two stool samples will be collected and symptom, food and quality of life questionnaires will need to be completed. Routine dietary advice will be provided at the end of the study to all patients as per routine clinical care.
Where is the study run from?
The study will be run from King's College London and St George's Healthcare Trust
When is the study starting and how long is it expected to run for?
Recruitment will continue until September 2014
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Heidi Staudacher, Research Dietitian
heidi.staudacher@kcl.ac.uk
Contact information
Scientific
King's College London
Franklin Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
Study information
| Study design | 2 x 2 factorial design randomised controlled 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 the contact details to request a patient information sheet |
| Scientific title | The impact of dietary interventions for irritable bowel syndrome on luminal microbiota, symptoms, nutrient intake and quality of life: a randomised controlled trial |
| Study objectives | Current study hypothesis as of 24/01/2013: There is no difference in luminal bifidobacteria concentration between participants after four weeks of a sham diet versus four weeks of a treatment diet with added probiotic. Previous study hypothesis until 24/01/2013: There is no difference in luminal bifidobacteria concentration between participants after four weeks of a sham diet versus four weeks of a fermentable carbohydrate restriction with added probiotic. |
| Ethics approval(s) | NRES Committee London-Fulham, 08/10/2012, ethics no. 12/LO/1402 |
| Health condition(s) or problem(s) studied | Irritable bowel syndrome |
| Intervention | Current interventions as of 24/01/2013: 4-week treatment diet + placebo 4-week treatment diet + added probiotic 4-week week sham diet + placebo 4-week sham diet + added probiotic Previous interventions until 24/01/2013: 4-week fermentable carbohydrate restriction + placebo 4-week fermentable carbohydrate restriction + added probiotic 4-week week sham diet + placebo 4-week sham diet + added probiotic |
| Intervention type | Mixed |
| Primary outcome measure | 1. Luminal bifidobacteria concentration between groups at 4 weeks Added 05/08/2014: 2. Proportion of participants with adequate relief of IBS symptoms at 4 weeks |
| Secondary outcome measures | 1. Difference in total and individual luminal gastrointestinal microbiota at 4 weeks 2. Difference in faecal short chain fatty acids and pH between groups at 4 weeks 3. Difference in IBS symptoms between groups at 4 weeks 4. Difference in stool consistency between groups at 4 weeks 5. Difference in nutrient intake between groups at 4 weeks 6. Difference in quality of life (QOL) scores between groups at 4 weeks |
| Overall study start date | 01/09/2012 |
| Completion date | 30/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 95 |
| Key inclusion criteria | 1. Men and women aged 18-65 years with IBS-D, IBS-M or unsubtyped IBS based on Rome III criteria who do not have a major medical condition (diabetes, psychiatric or current eating disorders) 2. Gastrointestinal disease (e.g. inflammatory bowel disease, coeliac disease) 3. History of previous GI surgery, except cholecystectomy and haemorrhoidectomy |
| Key exclusion criteria | 1. Females who report to be pregnant or lactating 2. Consumption of antibiotics, pre or probiotics (in food products or as supplements) in the last 4 weeks prior to, or during the study 3. Use of unpermitted medications (e.g. biological therapies) 4. Patients who have received bowel preparation for investigative procedures in the 4 weeks prior to the study 5. Patients who have had changes to IBS medications or dose in the 4 weeks prior to the study 6. Abdominal pain or discomfort for less than 2 days in the screening week, the frequency threshold recommended for clinical trials. Exclusion of those with minimal symptoms is recommended, and only those that experience pain on at least two days will be included. 7. Individuals with additional specific dietary needs |
| Date of first enrolment | 01/09/2012 |
| Date of final enrolment | 30/09/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SE1 9NH
United Kingdom
Sponsor information
University/education
Diabetes and Nutritional Sciences
Franklin Wilkins Building
150 Stamford Street
London
SE1 9NH
England
United Kingdom
| Website | http://www.kcl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
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 | 01/10/2017 | Yes | No | |
| Results article | results | 01/03/2018 | Yes | No | |
| Results article | results | 23/10/2020 | 16/11/2020 | Yes | No |
Editorial Notes
16/11/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
19/10/2017: Publication reference added.
11/10/2017: Publication reference added.
05/08/2014: The funder was changed from King's College London to National Institute for Health Research (NIHR) (UK).
05/08/2014: The target number of participants was changed from 93 to 100.
17/07/2013: The overall trial end date was changed from 01/08/2014 to 30/09/2014.
