Extrait

Background aims and objectives Irritable bowel syndrome (IBS) can be a painful and debilitating condition; it is associated with many different symptoms, the most common of which is abdominal (stomach) pain. It is one of the most frequent disorders seen by doctors at general gastroenterology clinics. Conventional treatment of IBS involves a combination of drugs, supportive psychotherapy and dietary manipulation; however, current drugs don’t work very well in many sufferers and often have unpleasant and severe side effects. The main aim of this study is to investigate the potential benefits of using a particular multi-strain (more than one bacteria) liquid probiotic (Symprove) in IBS. Benefits will be measured by asking patients to answer a special questionnaire that has been designed as a means for clinicians to monitor and assess IBS symptoms in patients under their care. Who can participate? The study aims to recruit adults, aged 18-65 years, who have had moderate to severe IBS for at least 6 months. What does the study involve? All patients would undergo an interview, physical examination and routine studies before the start of the trial. These studies would include many tests that are used routinely for IBS workup including blood tests and stool sampling. Patients will be randomly allocated into two groups; one group will receive the probiotic Symprove taken as a drink once a day, while the other will receive a similar placebo (dummy) drink once a day. Each participant will take probiotic or placebo for a period of three months followed by a two-month follow-up period, so the total length of the study for each participant will be about five months. Participants will visit the clinic every four weeks for monitoring and some of the studies undertaken at the start of the study may be repeated after one and three months treatment as part of routine care and at the end of the follow-up period of the study. What are the possible benefits and risks of participating? Many members of the public with IBS have taken this probiotic for their IBS symptoms. Anecdotally they have spoken of feeling better with a lessening of symptoms when taking the probiotic but this was not done in the context of a clinical trial. It is expected that participants in this study will have similar benefits. Some participants may experience some loosening of bowel motions in the first few days as the bacteria colonise the large bowel. No other adverse effects are anticipated. Where is the study run from? The study will be undertaken at King’s College Hospital, London (UK). When is the study starting and how long is it expected to run for? The study started in September 2008 and will run for about 2 years. Who is funding the study? The trial is funded by Kings College Hospital NHS Foundation Trust (UK). Who is the main contact? Prof. Ingvar Bjarnason (Chief investigator), [email protected] Dr Guy Sisson (Lead Investigator) , [email protected]

Critère d'inclusion

• Irritable bowel syndrome

Liens

• isrctn
• ictrp