Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil

• Sponsor: Helsinki University Central Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02110732
• Collaborator: Finnish Institute for Health and Welfare (Other)
• Enrollment: 40
• Arms: 2
• Duration (Months): 3.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Infection; Acute Otitis Media	Dietary Supplement: Lactobacillus rhamnosus GG	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil After Randomized, Double-blind, Placebo-controlled Oral Administration
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lactobacillus rhamnosus GG Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks	Dietary Supplement: Lactobacillus rhamnosus GG
Placebo Comparator: Crystalline cellulose Crystalline cellulose	Dietary Supplement: Lactobacillus rhamnosus GG

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 5 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• recurrent otitis media

• secretory otitis media

• chronic rhinitis

• recurrent sinusitis

Exclusion Criteria:

• significant illness

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Helsinki University Central Hospital
• Finnish Institute for Health and Welfare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Anne pitkäranta, Professor/Chief Physician at Hospital District of Helsinki and Uusimaa, Helsinki University Central Hospital
• ClinicalTrials.gov Identifier: NCT02110732
• Other Study ID Numbers: HelsinkiUCH
• First Posted: Apr 10, 2014
• Last Update Posted: Jun 2, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Respiratory Tract Infections; Otitis Media

Study Results

Participant Flow

Arm/Group Title	Lactobacillus Rhamnosus GG	Crystalline Cellulose
Arm/Group Description	Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG	Crystalline cellulose Lactobacillus rhamnosus GG
Period Title: Overall Study
STARTED	20	20
COMPLETED	14	17
NOT COMPLETED	6	3

Baseline Characteristics

Arm/Group Title	Lactobacillus Rhamnosus GG	Crystalline Cellulose	Total
Arm/Group Description	Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG	Crystalline cellulose Lactobacillus rhamnosus GG	Total of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	20 100%	20 100%	40 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	8 40%	9 45%	17 42.5%
Male	12 60%	11 55%	23 57.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Finland	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil
Description	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

Outcome Measure Data

Analysis Population Description

Number of participants with tympanostomy

Arm/Group Title	Lactobacillus Rhamnosus GG	Crystalline Cellulose
Arm/Group Description	Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG	Crystalline cellulose Lactobacillus rhamnosus GG
Measure Participants	10	3
Measure Samples	19	6
Count of Units [Samples]	4	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lactobacillus Rhamnosus GG, Crystalline Cellulose
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Fisher Exact
	Comments

2. Secondary Outcome

Title	Presence of Bacterial Pathogens in Middle Ear Effusion Samples
Description	Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear.
Time Frame	After 3 weeks of oral consumption

Outcome Measure Data

Analysis Population Description

Number of participants with tympanostomy

Arm/Group Title	Lactobacillus Rhamnosus GG	Crystalline Cellulose
Arm/Group Description	Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG	Crystalline cellulose Lactobacillus rhamnosus GG
Measure Participants	10	3
Measure Samples	19	6
Count of Units [Samples]	12	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lactobacillus Rhamnosus GG, Crystalline Cellulose
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.05
	Comments
	Method	Chi-squared
	Comments
Other Statistical Analysis		Categorical variables were analyzed with Chi-square test or Fisher's exact test. Comparisons between groups were by Levene's test for equality of variances. A P-level <0.05 was considered statistically significant. Data were analyzed with SPSS v.19 and NCSS.

3. Secondary Outcome

Title	Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples
Description	Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear.
Time Frame	After 3 weeks of oral consumption

Outcome Measure Data

Analysis Population Description

Number of participants with tympanostomy

Arm/Group Title	Lactobacillus Rhamnosus GG	Crystalline Cellulose
Arm/Group Description	Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG	Crystalline cellulose Lactobacillus rhamnosus GG
Measure Participants	10	3
Measure Samples	19	6
Count of Units [Samples]	11	1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lactobacillus Rhamnosus GG, Crystalline Cellulose
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.05
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	Lactobacillus Rhamnosus GG		Crystalline Cellulose
Arm/Group Description	Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG		Crystalline cellulose Lactobacillus rhamnosus GG
All Cause Mortality
	Lactobacillus Rhamnosus GG		Crystalline Cellulose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Serious Adverse Events
	Lactobacillus Rhamnosus GG		Crystalline Cellulose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Lactobacillus Rhamnosus GG		Crystalline Cellulose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.