Extrait

Background and study aims Upper respiratory tract illness (URTI) is the most common respiratory illness experienced by the general population and sore throat is the most common URTI managed in the NHS, costing the NHS an estimated £25 million in consultations alone. Antibiotic use for respiratory tract illnesses has decreased since 1997 but is still double the rate of other Northern European countries, and costs the NHS an additional £6-12 million in prescribing costs per annum. Xylitol (used in some sugar-free gum) is a birch sugar, and causes local 'bacterial interference' by inhibiting the growth and adherence of bacteria to the throat. Sorbitol has no such effect and will be used as a 'placebo' (dummy) gum. Probiotics, which are also available commercially, are benign non-pathogenic bacteria and may also act through local 'bacterial interference' by a different mechanism and may also have an effect on non-specific general activation of the immune system. Although there are studies that support the use of both xylitol and probiotics in the management of recurrent infections, this evidence needs confirming, and we particularly need evidence about their effectiveness for either symptoms or recurrence of sore throat. In addition there is no clear evidence concerning the effect of chewing any kind of gum on the symptoms of sore throat. The effectiveness of chewing xylitol and probiotics in URTIs requires urgent clarification both for the general public and for the health service. Since probiotics and xylitol act via different mechanisms, a study is needed to assess the possible interaction of both interventions together. This study aims to investigate the effect of xylitol and probiotics on symptoms and recurrence of sore throat. Who can participate? Patients over the age of 16, presenting with acute sore throat. What does the study involve? We will provide participants with instructions and randomly allocate them to receive a treatment pack containing 3 months' supply of either just probiotic capsules (to take one capsule daily) or probiotic capsules and chewing gum (to chew five pieces a day). As some people get better just because they are taking something they believe to be helpful (a placebo), some of our packs have pretend treatments in them - they will look and taste the same as the real thing and participants won't know which one they've got until the end of the study. What are the possible benefits and risks of participating? Not provided at time of registration. Where is the study run from? The study was lead and run by the trial management team in Southampton, and we recruited participants from 83 practices from Land's End to Ipswich. When is the study starting and how long is it expected to run for? The study will run from November 2008 to January 2015. Recruitment closed in July 2014. Who is funding the study? National Institute for Health Research (NIHR) (UK). Who is the main contact? Ms Tammy Thomas

Critère d'inclusion

• Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Liens

• ictrp
• isrctn