Condition category
Ear, Nose and Throat
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
20/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.soton.ac.uk

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

Publication citations

Additional files

Editorial Notes