Extract

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 the sufferers quality of life. A diet with an altered amount of carbohydrates (e.g. the types of fruits and vegetables) might prevent 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, a group of bacteria that live in the bowel. Prebiotics can promote (increase) the amount of friendly bifidobacteria in the bowel. This study will investigate the effect of this diet with a prebiotic 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. Changes to urine health markers in relation to the gut bacteria changes 5. Dietary intake 6. Quality of life Who can participate? Patients of Guy's and St Thomas' NHS Foundation Trust or Barts and the London NHS Trust aged 18-65 years with IBS and without another major medical condition are eligible for this study What does the study involve? Participants are randomly allocated into one of three groups. Those in group 1 are placed on a “sham” diet (one that is not expected to make a difference to the persons IBS symptoms) and are given a placebo pill to take for 4 weeks. Those in group 2 are placed on the treatment diet for 4 weeks and are given a placebo. Those in group 3 are also placed on the treatment diet and take the probiotic for 4 weeks. Each participant visits their study centre three times, once before the study begins, once at one week into the study period and once after the study ends. Participants are assessed according to, for example, what symptoms they experience, their nutrient uptake, quality of life and acceptability of the diet and food supplement. 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. Three stool samples and three urine 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? King’s College London and The Royal London Hospital (UK) When is the study starting and how long is it expected to run for? May 2015 to March 2017 Who is funding the study? Study funding with research grant from Clasado (UK) ltd and departmental funding from King's College London Nutritional Sciences Division Who is the main contact? Bridgette Wilson [email protected]

Inclusion criteria

• Irritable bowel syndrome

Links

• isrctn
• ictrp