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NCT02110732 Clinical Trial

Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil

Acute Otitis Media Clinical Trial

Official title:
Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil After Randomized, Double-blind, Placebo-controlled Oral Administration

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02110732
Other study ID # HelsinkiUCH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2011
Est. completion date May 2011

Study information
Verified date May 2021
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of oral administration of probiotic Lactobacillus rhamnosus GG in middle ear and adenoid tonsil.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 5 Years
Eligibility Inclusion Criteria: - recurrent otitis media - secretory otitis media - chronic rhinitis - recurrent sinusitis Exclusion Criteria: - significant illness

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Lactobacillus rhamnosus GG

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Helsinki University Central Hospital Finnish Institute for Health and Welfare

Outcome
Type Measure Description Time frame Safety issue
Primary Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil Presence of Lactobacillus rhamnosus GG in middle ear effusion of children having tympanostomy after oral administration of L. GG. After 3 weeks of oral consumption
Secondary Presence of Bacterial Pathogens in Middle Ear Effusion Samples Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear. After 3 weeks of oral consumption
Secondary Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear. After 3 weeks of oral consumption
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