Trial Outcomes & Findings for Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil (NCT NCT02110732)

Results Overview

Presence of Lactobacillus rhamnosus GG in middle ear effusion of children having tympanostomy after oral administration of L. GG.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

After 3 weeks of oral consumption

Results posted on

2021-06-02

Participant Flow

Participant milestones

Participant milestones
Measure	Lactobacillus Rhamnosus GG Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG	Crystalline Cellulose Crystalline cellulose Lactobacillus rhamnosus GG
Overall Study STARTED	20	20
Overall Study COMPLETED	14	17
Overall Study NOT COMPLETED	6	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Lactobacillus Rhamnosus GG Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG	Crystalline Cellulose Crystalline cellulose Lactobacillus rhamnosus GG
Overall Study Physician Decision	5	2
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lactobacillus Rhamnosus GG n=20 Participants Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG	Crystalline Cellulose n=20 Participants Crystalline cellulose Lactobacillus rhamnosus GG	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Sex: Female, Male Female	8 Participants n=20 Participants	9 Participants n=20 Participants	17 Participants n=40 Participants
Sex: Female, Male Male	12 Participants n=20 Participants	11 Participants n=20 Participants	23 Participants n=40 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Finland	20 Participants n=20 Participants	20 Participants n=20 Participants	40 Participants n=40 Participants

PRIMARY outcome

Timeframe: After 3 weeks of oral consumption

Population: Number of participants with tympanostomy

Presence of Lactobacillus rhamnosus GG in middle ear effusion of children having tympanostomy after oral administration of L. GG.

Outcome measures

Outcome measures
Measure	Lactobacillus Rhamnosus GG n=19 Samples Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG	Crystalline Cellulose n=6 Samples Crystalline cellulose Lactobacillus rhamnosus GG
Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil	4 Samples	1 Samples

SECONDARY outcome

Timeframe: After 3 weeks of oral consumption

Population: Number of participants with tympanostomy

Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear.

Outcome measures

Outcome measures
Measure	Lactobacillus Rhamnosus GG n=19 Samples Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG	Crystalline Cellulose n=6 Samples Crystalline cellulose Lactobacillus rhamnosus GG
Presence of Bacterial Pathogens in Middle Ear Effusion Samples	12 Samples	3 Samples

SECONDARY outcome

Timeframe: After 3 weeks of oral consumption

Population: Number of participants with tympanostomy

Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear.

Outcome measures

Outcome measures
Measure	Lactobacillus Rhamnosus GG n=19 Samples Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Lactobacillus rhamnosus GG	Crystalline Cellulose n=6 Samples Crystalline cellulose Lactobacillus rhamnosus GG
Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples	11 Samples	1 Samples

Adverse Events

Lactobacillus Rhamnosus GG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Crystalline Cellulose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anne Pitkäranta

Helsinki University Hospital

Phone: +358406430511

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place