A double blind randomised placeabo trial of probiotics in the prevention of episodes of otitis in general practice
| DEC-NET Serial number GB597 | |
| Published online | 06/09/2006 15.00.00 |
| Last updated | 06/09/2006 14.59.09 |
| Other protocol ID number | N/A |
| This trial has been approved by an ethics committee | |
| Current trial status | Open (actively recruiting new participants) |
| Major Disease (ICD9 class) | UNSPECIFIED OTITIS MEDIA |
| Experimental drug | |
| Probiotic | |
| Gender | Both |
| Age (range) | 6 months to 11 years |
Eligibility criteria | |
| Inclusion criteria | |
| Children with a previous history of otalgia between 6 months and 11 years | |
| Exclusion criteria | |
| Consent not given | |
Trial design/methodology | |
| Phase | 4 |
| Kind of study | Efficacy |
| Design | Controlled Randomised Blinded Double blind |
| Purpose of study | |
| To determine the effectiveness of a course of probiotics in reducing reported episodes of acute otalgia and ear problems over the winter months, and consultations with otitis media | |
| Primary outcomes | |
| Effectiveness of a course of probiotics in reducing reported episodes of acute otalgia and ear problems | |
| Secondary outcomes | |
| None | |
| Summary of study design, objectives, and ongoing research findings | |
| A double blind randomised placebo trial to investigate the use of probiotics in the prevention of episodes of otitis in general practice | |
| Principal investigator | |
| Name | Ian Williamson |
| Institution | University of Southampton |
| Postal address | Aldermoor Close, SO165ST |
| City | Southampton |
| Country | UNITED KINGDOM |
| Phone | +44 (02380) 241071 |
| Fax | (02380) 701125 |
| igw@soton.ac.uk | |
| Sponsor name |
| University of Southampton (University) |
| ISRCTN 53286030 | EudraCT |
