Extrait

Background and study aims Infectious diarrhoea is caused by pathogens invading the human host and disrupting the normal colonic flora of the gut or by an overgrowth of existing bacteria. The most common infectious cause of nosocomial or healthcare acquired diarrhoea is Clostridium difficile. In severe cases, the illness leads to dehydration and death. There is very little data on the incidence of antibiotic-associated diarrhoea (AAD) in long term care facilities. Each case causes suffering, potential serious complications and exposes other residents to risk of infection. This adds to the burden on staff in long term care facilities from increased work load, greater patient transfers and reduced morale, all of which becomes worse in a cluster or outbreak. The purpose of this study is to look at whether the co-administration of probiotics with acute antibiotic treatment reduces the incidence of antibiotic-associated diarrhoea among service users at care homes. Who can participate? Adults who do not meet any of the exclusion criteria and who are usually resident in participating nursing or dual-registered care homes in the UK who are prescribed antibiotics during the study period. We will also include adults who lack mental capacity for whom we have a personal/professional legal representative. What does the study involve? If you are given antibiotics in the course of your usual medical care at any point during the following 12 months and you agree to take part, you will be randomly assigned (equivalent to the toss of a coin) either to the active treatment or the placebo (the placebo will resemble the active treatment in every way except it will not contain any active ingredients). The study preparation will be prepared for you by the care home staff. It will be provided twice every day for 21 days. Relevant details related to your medical history will be recorded. You will be monitored for eight weeks: This includes information being collected on the antibiotics and study preparation you are taking, whether you have had diarrhoea and how you are feeling each week. At the end of the eight weeks information about any other treatments that you have been given and whether you have had to go to hospital or have other treatment will be collected. If you develop diarrhoea during the eight weeks, the care home staff will collect a sample of your stool and send this to our laboratory for tests. What are the possible benefits and risks of participating? There may be some potential benefits for you if the probiotic does prevent or reduce the severity of diarrhoea caused by treatment with antibiotics. However, there will be no direct benefit to you in the event that you are randomly selected to take a placebo. The proposed study does pose ethical issues, namely the conduct of a randomised placebo controlled trial in a population with the potential challenge of mental capacity. For this reason, prior to enrolment and at randomisation, the mental capacity of all service users (SUs) will be assessed by trained staff. The Medicines and Healthcare products Regulatory Agency (MHRA) considers this study to be an efficacy study of VSL#3 in a new and unlicensed indication and have defined this study to be a Type B trial, which identifies the risk to service users as being somewhat higher than that of standard medical care. The study medication will be delivered by appropriately trained and experienced care home- clinical staff or study trained staff, managed and monitored by South East Wales Trials Unit. Where is the study run from? Participating nursing or dual-registered care homes in the UK. When is the study starting and how long is it expected to run for? Recruitment is expected to start in April 2013 and will end in April 2014. Service users will be followed up for eight weeks from the date of randomisation. Who is funding the study? Heath Technology Assessment (HTA) Who is the main contact? Prof Christopher Butler B [email protected]

Critère d'inclusion

• Antibiotic Associated Diarrhoea

Liens

• isrctn
• ictrp