Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil

Not Applicable

Completed

• Conditions: Acute Otitis Media; Upper Respiratory Infection
• Interventions: Dietary Supplement: Lactobacillus rhamnosus GG

• Registration Number: NCT02110732
• Lead Sponsor: Helsinki University Central Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2014-03-11
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Results First Submitted: 2021-03-18
• Results First Submitted QC: 2021-04-19
• Status Verified: 2021-05
• Results First Posted: 2021-05-11
• Last Update Submitted: 2021-05-11
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• recurrent otitis media
• secretory otitis media
• chronic rhinitis
• recurrent sinusitis

Exclusion Criteria

• significant illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus rhamnosus GG	Lactobacillus rhamnosus GG	Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks
Crystalline cellulose	Lactobacillus rhamnosus GG	Crystalline cellulose

Primary Outcome Measures

Name	Time	Method
Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil	After 3 weeks of oral consumption	Presence of Lactobacillus rhamnosus GG in middle ear effusion of children having tympanostomy after oral administration of L. GG.

Secondary Outcome Measures

Name	Time	Method
Presence of Bacterial Pathogens in Middle Ear Effusion Samples	After 3 weeks of oral consumption	Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear.
Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples	After 3 weeks of oral consumption	Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear.