Extrait

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 We are also interested in the effect of dietary change on symptoms and the bacteria in the bowel in the longer term. Who can participate? Patients of Guy's and St Thomas' NHS Foundation Trust or St George's Healthcare Trust aged 18-65 years with IBS and without another major medical condition are eligible for this study. Other exclusion criteria apply regarding medication intake, types of symptoms and previous medical history, such as surgery. 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). Reimbursement for expenses will not be available for this study. Who is the main contact? Heidi Staudacher, Research Dietitian [email protected]

Critère d'inclusion

• Irritable bowel syndrome

Liens

• ictrp
• isrctn