A controlled trial of Probiotics in the prevention of episodes of otitis media in general practice

ISRCTN ISRCTN53286030
DOI https://doi.org/10.1186/ISRCTN53286030
Protocol serial number N0230131783
Sponsor University of Southampton (UK)
Funder West Hampshire Consortium (UK)
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
18/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Ian Williamson
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleA controlled trial of Probiotics in the prevention of episodes of otitis media in general practice
Study acronymPIPO
Study objectivesNot provided at time of registration
Ethics approval(s)Southampton and South West Hampshire LREC (UK), 01/09/2003, ref: 174/03/t
Health condition(s) or problem(s) studiedEar, Nose and Throat: Otitis media
InterventionA 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 typeOther
Primary outcome measure(s)

Reported episodes of recurrent significant otalgia difference in proportions over 3 months measured by questionnaires

Key secondary outcome measure(s)

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

Completion date31/05/2008

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
Upper age limit11 Years
SexAll
Target sample size at registration300
Key inclusion criteriaChildren 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
Key exclusion criteriaChildren will be excluded if they have an allergy to either product or those with failure to thrive
Date of first enrolment01/09/2003
Date of final enrolment31/05/2008

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

University of Southampton
Southampton
S016 5ST
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

18/10/2017: No publications found, study status unverified

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