Contact information
Type
Scientific
Primary contact
Dr Ian Williamson
ORCID ID
Contact details
Dept of Primary Medical Care
University of Southampton
Aldermoor Health Centre
Southampton
S016 5ST
United Kingdom
+44 (0)23 8024 1071
igw@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0230131783
Study information
Scientific title
A controlled trial of Probiotics in the prevention of episodes of otitis media in general practice
Acronym
PIPO
Study hypothesis
Not provided at time of registration
Ethics approval
Southampton and South West Hampshire LREC (UK), 01/09/2003, ref: 174/03/t
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Ear, Nose and Throat: Otitis media
Intervention
A number of GP practices will recruit patients over 2 winters. From the participating practices computer records, children most at risk of several recurrences over the winter months based on previous attendance with otitis media and recorded ear or ear problems. Parents and children will be invited by their GPs to attend special 'surgeries' run by the 4th year student/GP and sent a specifically designed self help leaflet and other information. After informed consent procedures patients will be randomised by using random number sequences to produce coded blocks of 4 which contain either active treatment or placebo. The probiotics lactobacillus and bifdobacteria and placebo used are currently under trial at Addenbrokes for gastrointestinal (GI) infections. Parents will attend for a second interview and completion of trial materials after 3 months. Stool samples will be collected at the beginning and end of the trial to compare the effect on bowel flora.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Reported episodes of recurrent significant otalgia difference in proportions over 3 months measured by questionnaires
Secondary outcome measures
1. Otitis media episodes in medical records change in specified outcome measure OM7-27 continuous variable score in 5 clinically important domains
2. To evaluate compliance issues for once daily, 3 month course in this context
3. Description of change in stool microbiology
Overall trial start date
01/09/2003
Overall trial end date
31/05/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Children aged 6 months to 11 years with a notes recorded episode of acute otitis media over the previous 12 months or an episode of any other specified ear problem
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Added 17/07/2008: 300
Participant exclusion criteria
Children will be excluded if they have an allergy to either product or those with failure to thrive
Recruitment start date
01/09/2003
Recruitment end date
31/05/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Southampton
Southampton
S016 5ST
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
c/o Dr Martina Prude (Research Governance Manager)
University of Southampton
Room 4009
Legal Services
Building 37
Highfield
London
SO17 1BJ
United Kingdom
+44 (0)23 8059 8848/9
mad4@soton.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
West Hampshire Consortium (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary