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| Name | Class |
|---|---|
| Finnish Institute for Health and Welfare | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus rhamnosus GG | Active Comparator | Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks |
|
| Crystalline cellulose | Placebo Comparator | Crystalline cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus rhamnosus GG | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of Bacterial Pathogens in Middle Ear Effusion Samples | Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear. | After 3 weeks of oral consumption |
| Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25085073 | Derived | 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. |
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There is not a plan to share IPD.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lactobacillus Rhamnosus GG | Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG |
| FG001 | Crystalline Cellulose | Crystalline cellulose Lactobacillus rhamnosus GG |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lactobacillus Rhamnosus GG | Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG |
| BG001 | Crystalline Cellulose | Crystalline cellulose Lactobacillus rhamnosus GG |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of participants with tympanostomy | Posted | Count of Units | Samples | After 3 weeks of oral consumption | Samples | Samples |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lactobacillus Rhamnosus GG | Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anne Pitkäranta | Helsinki University Hospital | +358406430511 | anne.pitkaranta@hus.fi |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D010031 | Otitis |
| D004427 | Ear Diseases |
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Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear. |
| After 3 weeks of oral consumption |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Samples |
|
|
|
| Secondary | Presence of Bacterial Pathogens in Middle Ear Effusion Samples | Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear. | Number of participants with tympanostomy | Posted | Count of Units | Samples | After 3 weeks of oral consumption | Samples | Samples |
|
|
|
|
| Secondary | Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples | Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear. | Number of participants with tympanostomy | Posted | Count of Units | Samples | After 3 weeks of oral consumption | Samples | Samples |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Crystalline Cellulose | Crystalline cellulose Lactobacillus rhamnosus GG | 0 | 20 | 0 | 20 | 0 | 20 |
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| D010038 |
| Otorhinolaryngologic Diseases |