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
Secondary identifying numbers	N0230131783

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

Phone	+44 (0)23 8024 1071
Email	igw@soton.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A controlled trial of Probiotics in the prevention of episodes of otitis media in general practice
Study acronym	PIPO
Study objectives	Not 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) studied	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
Primary outcome measure	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 study start date	01/09/2003
Completion date	31/05/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	11 Years
Sex	Both
Target number of participants	Added 17/07/2008: 300
Key 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
Key exclusion criteria	Children will be excluded if they have an allergy to either product or those with failure to thrive
Date of first enrolment	01/09/2003
Date of final enrolment	31/05/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Southampton

Southampton
S016 5ST
United Kingdom

Sponsor information

University of Southampton (UK)
University/education

c/o Dr Martina Prude (Research Governance Manager)
University of Southampton
Room 4009, Legal Services
Building 37
Highfield
London
SO17 1BJ
England
United Kingdom

Phone	+44 (0)23 8059 8848/9
Email	mad4@soton.ac.uk
Website	http://www.soton.ac.uk
"ROR"	https://ror.org/01ryk1543

Funders

Funder type

Government

West Hampshire Consortium (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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