Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2011
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 11, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedResults Posted
Study results publicly available
May 11, 2021
CompletedJune 2, 2021
May 1, 2021
4 months
March 11, 2014
March 18, 2021
May 11, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Presence of Bacterial Pathogens in Middle Ear Effusion Samples
After 3 weeks of oral consumption
Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples
After 3 weeks of oral consumption
Study Arms (2)
Lactobacillus rhamnosus GG
ACTIVE COMPARATORLactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks
Crystalline cellulose
PLACEBO COMPARATORCrystalline cellulose
Interventions
Eligibility Criteria
You may qualify if:
- recurrent otitis media
- secretory otitis media
- chronic rhinitis
- recurrent sinusitis
You may not qualify if:
- significant illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 25085073DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anne Pitkäranta
- Organization
- Helsinki University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor/Chief Physician at Hospital District of Helsinki and Uusimaa
Study Record Dates
First Submitted
March 11, 2014
First Posted
April 10, 2014
Study Start
January 1, 2011
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
June 2, 2021
Results First Posted
May 11, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share
There is not a plan to share IPD.