Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil

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

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

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Infection; Acute Otitis Media
• Intervention / Treatment: Dietary supplement: Lactobacillus rhamnosus GG

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• significant illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lactobacillus rhamnosus GG; Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks	Dietary supplement: Lactobacillus rhamnosus GG
Placebo Comparator: Crystalline cellulose	Dietary supplement: Lactobacillus rhamnosus GG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Finnish Institute for Health and Welfare

Publications and helpful links

General Publications

• Tapiovaara L, Lehtoranta L, Swanljung E, Makivuokko H, Laakso S, Roivainen M, Korpela R, Pitkaranta A. Lactobacillus rhamnosus GG in the middle ear after randomized, double-blind, placebo-controlled oral administration. Int J Pediatr Otorhinolaryngol. 2014 Oct;78(10):1637-41. doi: 10.1016/j.ijporl.2014.07.011. Epub 2014 Jul 18.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: March 11, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 11, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Respiratory Tract Infections
• Other Study ID Numbers: HelsinkiUCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to share IPD.