Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil

NCT ID: NCT02110732

Last Updated: 2021-06-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Upper Respiratory Infection Acute Otitis Media

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lactobacillus rhamnosus GG

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

Group Type ACTIVE_COMPARATOR

Lactobacillus rhamnosus GG

Intervention Type DIETARY_SUPPLEMENT

Crystalline cellulose

Crystalline cellulose

Group Type PLACEBO_COMPARATOR

Lactobacillus rhamnosus GG

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactobacillus rhamnosus GG

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* recurrent otitis media
* secretory otitis media
* chronic rhinitis
* recurrent sinusitis

Exclusion Criteria

* significant illness
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Finnish Institute for Health and Welfare

OTHER_GOV

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anne pitkäranta

Professor/Chief Physician at Hospital District of Helsinki and Uusimaa

Responsibility Role PRINCIPAL_INVESTIGATOR

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25085073 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HelsinkiUCH

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Probiotics to Promote Intestinal Health
NCT02046512 COMPLETED PHASE4