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Completed

NCT Number: NCT02110732

Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil

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

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Key information

Conditions

Upper Respiratory Infection Acute Otitis Media Ear Diseases Infections Otitis Otitis Media Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • significant illness

Treatment and study plan

Lactobacillus rhamnosus GG

Dietary Supplement

Primary outcomes

  1. Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil

    Time frame: 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 outcomes

  1. Presence of Bacterial Pathogens in Middle Ear Effusion Samples

    Time frame: After 3 weeks of oral consumption

    Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear.

  2. Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples

    Time frame: After 3 weeks of oral consumption

    Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Finnish Institute for Health and Welfare

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 10, 2014
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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