Probiotics for Antibiotic Associated Diarrhoea, (PAAD), a randomised c

• Research type

  Research Study

• Full title

  A double blind placebo controlled randomised clinical trial to study the effect of Probiotics for the prevetion or amelioration of Antibiotic Associated Diarrhoea in residents of care homes in South Wales and England

• IRAS ID

  92548

• Contact name

  Christopher Butler

• Sponsor organisation

  CARDIFF UNIVERSITY

• Eudract number

  2011-006269-17

• Clinicaltrials.gov Identifier

  1

• Research summary

  PAAD Stage II is a multi-centre double-blinded placebo-controlled two arm individually randomised trial of the effect of probiotics on Antibiotic Associated Diarrhoea (AAD) in Service Users (SUs) of care homes. The primary objective is to assess the effect of probiotics, taken in conjunction with antibiotics, on the incidence of AAD. This will be ascertained by comparing the proportion of SUs in each arm that experience at least one episode of AAD during the eight weeks following randomisation (beginning on commencement of antibiotics). We aim to recruit 400 SUs (200 per arm) from approximately 24 care homes. General Practitioners (GPs) serving the recruited care homes will be fully informed of the study. SUs and their relatives will be fully informed of the study using written materials and posters in care homes, supplemented with verbal explanations. Consent will be taken from SUs where they are able and willing to provide this. In the event of cognitive impairment that limits ability to provide fully informed consent, the SU??s personal or legal representative will be approached to provide consent for their relative to take part . Consent will be taken at the time of enrolment to confirm, in advance, that in the event of an antibiotic being prescribed by a responsible clinician at any point during the subsequent year (12 months), the SU will be randomised to receive a probiotic or matched placebo. If SUs are prescribed an antibiotic in the course of usual care at any time during the following 12 months, they will be assessed by the GP and the Research Nurse to ensure that they remain eligible and willing to participate in the trial. The SU will be randomised to receive probiotics (VSL#3) or placebo in addition to their antibiotic prescription. Randomised SUs will begin treatment of probiotics or placebo no later than 72 hours after commencement of their antibiotic course and will be instructed to take one sachet twice a day for 21 days. SUs will be followed up for eight weeks following their first antibiotic dose.

• REC name

  Wales REC 1

• REC reference

  12/WA/0057

• Date of REC Opinion

  15 Jun 2012

• REC opinion

  Further Information Favourable Opinion