Upper Respiratory Infection, Acute Otitis Media
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLactobacillus rhamnosus GG
Sponsors
Finnish Institute for Health and Welfare
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
* recurrent otitis media * secretory otitis media * chronic rhinitis * recurrent sinusitis
Exclusion criteria
* significant illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil | 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
| Measure | Time frame | Description |
|---|---|---|
| Presence of Bacterial Pathogens in Middle Ear Effusion Samples | After 3 weeks of oral consumption | Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear. |
| Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples | After 3 weeks of oral consumption | Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lactobacillus Rhamnosus GG Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks
Lactobacillus rhamnosus GG | 20 |
| Crystalline Cellulose Crystalline cellulose
Lactobacillus rhamnosus GG | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Physician Decision | 5 | 2 |
Baseline characteristics
| Characteristic | Crystalline Cellulose | Total | Lactobacillus Rhamnosus GG |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 40 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Finland | 20 Participants | 40 Participants | 20 Participants |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Male | 11 Participants | 23 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: After 3 weeks of oral consumption
Population: Number of participants with tympanostomy
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Lactobacillus Rhamnosus GG | Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil | 4 Samples |
| Crystalline Cellulose | Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil | 1 Samples |
p-value: 0.05Fisher Exact
Secondary
Presence of Bacterial Pathogens in Middle Ear Effusion Samples
Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear.
Time frame: After 3 weeks of oral consumption
Population: Number of participants with tympanostomy
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Lactobacillus Rhamnosus GG | Presence of Bacterial Pathogens in Middle Ear Effusion Samples | 12 Samples |
| Crystalline Cellulose | Presence of Bacterial Pathogens in Middle Ear Effusion Samples | 3 Samples |
p-value: <0.05Chi-squared
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.
Time frame: After 3 weeks of oral consumption
Population: Number of participants with tympanostomy
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Lactobacillus Rhamnosus GG | Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples | 11 Samples |
| Crystalline Cellulose | Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples | 1 Samples |
p-value: <0.05Chi-squared