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Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil

Primary Purpose

Upper Respiratory Infection, Acute Otitis Media

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lactobacillus rhamnosus GG
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Upper Respiratory Infection

Eligibility Criteria

1 Year - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • significant illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Lactobacillus rhamnosus GG

    Crystalline cellulose

    Arm Description

    Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks

    Crystalline cellulose

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Presence of Bacterial Pathogens in Middle Ear Effusion Samples
    Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear.
    Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples
    Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear.

    Full Information

    First Posted
    March 11, 2014
    Last Updated
    May 11, 2021
    Sponsor
    Helsinki University Central Hospital
    Collaborators
    Finnish Institute for Health and Welfare
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02110732
    Brief Title
    Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil
    Official Title
    Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil After Randomized, Double-blind, Placebo-controlled Oral Administration
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2011 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    May 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Helsinki University Central Hospital
    Collaborators
    Finnish Institute for Health and Welfare

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Upper Respiratory Infection, Acute Otitis Media

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lactobacillus rhamnosus GG
    Arm Type
    Active Comparator
    Arm Description
    Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks
    Arm Title
    Crystalline cellulose
    Arm Type
    Placebo Comparator
    Arm Description
    Crystalline cellulose
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Lactobacillus rhamnosus GG
    Primary Outcome Measure Information:
    Title
    Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil
    Description
    Presence of Lactobacillus rhamnosus GG in middle ear effusion of children having tympanostomy after oral administration of L. GG.
    Time Frame
    After 3 weeks of oral consumption
    Secondary Outcome Measure Information:
    Title
    Presence of Bacterial Pathogens in Middle Ear Effusion Samples
    Description
    Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear.
    Time Frame
    After 3 weeks of oral consumption
    Title
    Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples
    Description
    Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear.
    Time Frame
    After 3 weeks of oral consumption

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: recurrent otitis media secretory otitis media chronic rhinitis recurrent sinusitis Exclusion Criteria: significant illness

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    There is not a plan to share IPD.
    Citations:
    PubMed Identifier
    25085073
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

    Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil

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