An interventional study of Probiotic and Placebo in Upper Respiratory Tract Infection (URTI), sponsored by BioGaia AB. Not yet recruiting at 2 sites in Italy. Open to participants aged 4 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by BioGaia AB · Not applicable, Interventional, and Prevention
This randomized, double-blind, placebo-controlled pilot study will evaluate the effect of a probiotic supplement on upper respiratory tract infections (URTIs) in children aged 4-18 years with a history of recurrent URTIs. Participants will be randomized to receive either probiotic drops or placebo drops. The primary objective is to assess the effect of the probiotic on the frequency of URTI episodes during the study period. Secondary objectives include evaluation of respiratory symptoms, medication use, healthcare visits, school absenteeism, recovery of the administered probiotic, and safety.
751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
This study's planned enrollment of 70 is below the median of 200 across 540 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →BioGaia AB is the lead sponsor of 20 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Probiotic oil drops formulation. Administration twice daily.
Other: Probiotic
Placebo oil drops formulation. Administration twice daily.
Other: Placebo
Probiotic drops
Placebo drops
Number of episodes
Number of episodes presenting with three out of four of the following symptoms for three consecutive days: Fever, sore throat, nasal congestion or runny nose.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Apr 2028, 19 months later.
Of 27 industry-sponsored interventional studies with no phase under Respiratory Tract Infections, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's planned 19 months is above that.
Counting every sponsor, half of 143 studies reached it within 11 months; a quarter within 6 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Respiratory Tract Infections →
BioGaia AB