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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53286030
Enrollment
300
Registered
2004-09-30
Start date
2003-09-01
Completion date
Unknown
Last updated
2017-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ear, Nose and Throat: Otitis media Ear, Nose and Throat Otitis media

Interventions

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

Sponsors

University of Southampton (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Children will be excluded if they have an allergy to either product or those with failure to thrive

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026