N/A
N=40
Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil
Upper Respiratory Infection · Acute Otitis Media
Bottom Line
View on ClinicalTrials.gov: NCT02110732 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil — 4; 1 Samples — p=0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lactobacillus rhamnosus GG (Dietary_supplement)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Helsinki University Central Hospital
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil |
4; 1 | 0.05 |
| SECONDARY Presence of Bacterial Pathogens in Middle Ear Effusion Samples |
12; 3 | < 0.05 sig |
| SECONDARY Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples |
11; 1 | < 0.05 sig |
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.
Eligibility Criteria
Inclusion Criteria
- recurrent otitis media
- secretory otitis media
- chronic rhinitis
- recurrent sinusitis
Exclusion Criteria
- significant illness
Data sourced from ClinicalTrials.gov (NCT02110732). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.