Upper Respiratory InfectionNCT02110732
Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil
A study testing Lactobacillus rhamnosus GG in people with Upper Respiratory Infection and Acute Otitis Media, run by Helsinki University Central Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Infection, Acute Otitis Media
- What is being tested?
- Lactobacillus rhamnosus GG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- recurrent otitis media
- secretory otitis media
- chronic rhinitis
- recurrent sinusitis
Who cannot join
- significant illness
About this study
Official title: Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil After Randomized, Double-blind, Placebo-controlled Oral Administration
The purpose of this study is to evaluate the effect of oral administration of probiotic Lactobacillus rhamnosus GG in middle ear and adenoid tonsil.
- Conditions
- Upper Respiratory Infection, Acute Otitis Media
- Being tested
- Lactobacillus rhamnosus GG
- Medical subject headings
- Respiratory Tract Infections, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus rhamnosus GGDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus rhamnosus GG | Active comparator | Lactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks Receives: Dietary Supplement: Lactobacillus rhamnosus GG |
| Crystalline cellulose | Placebo comparator | Crystalline cellulose Receives: Dietary Supplement: Lactobacillus rhamnosus GG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 3 weeks of oral consumption
Secondary outcomes (2)
Presence of Bacterial Pathogens in Middle Ear Effusion Samples
Association of Lactobacillus rhamnosus GG with occurrence of bacterial pathogens in the middle ear.
Measured: After 3 weeks of oral consumption
Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples
Association of Lactobacillus rhamnosus GG with occurrence of viral pathogens in the middle ear.
Measured: After 3 weeks of oral consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare
- Responsible party
- Principal investigator, Anne pitkäranta, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110732
- Sponsor's protocol ID
- HelsinkiUCH
- Status last verified
- May 2021
- First submitted
- 11 Mar 2014
- Last updated
- 2 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: There is not a plan to share IPD.
Publications
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.
PubMed 25085073
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lactobacillus Rhamnosus GG in the Middle Ear and Adenoid Tonsil After Randomized, Double-blind, Placebo-controlled Oral Administration
- ClinicalTrials.gov ID
- NCT02110732
- Acronym / sponsor ID
- HelsinkiUCH
- Conditions
- Upper Respiratory Infection, Acute Otitis Media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 10 Apr 2014 (estimated)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of oral administration of probiotic Lactobacillus rhamnosus GG in middle ear and adenoid tonsil.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus rhamnosus GG | Active comparator | Dietary Supplement: Lactobacillus rhamnosus GGLactobacillus rhamnosus GG 8-9 x 10 -9 pmy 2x2 for 3 weeks |
| Crystalline cellulose | Placebo comparator | Dietary Supplement: Lactobacillus rhamnosus GGCrystalline cellulose |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- recurrent otitis media
- secretory otitis media
- chronic rhinitis
- recurrent sinusitis
Key exclusion criteria (1 listed)
- significant illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus rhamnosus GG | Dietary supplement | Crystalline cellulose, Lactobacillus rhamnosus GG |
Primary outcome
Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil
Time frame: 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.
2 secondary outcomes
Presence of Bacterial Pathogens in Middle Ear Effusion Samples
Time frame: After 3 weeks of oral consumption
Presence of Rhinovirus and Enterovirus in Middle Ear Effusion Samples
Time frame: After 3 weeks of oral consumption
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25085073Tapiovaara 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.
- Individual participant dataSharing planned: No. There is not a plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus rhamnosus GG in people with Upper Respiratory Infection and Acute Otitis Media, run by Helsinki University Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactobacillus Rhamnosus GG in Middle Ear Effusion and Adenoid Tonsil (time frame: After 3 weeks of oral consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02110732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.