Probiotics for Sustained Health

NCT07835100 — Not applicable, Not yet recruiting, 70 participants, BioGaia AB

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A Pilot Study; a Randomized Double-blind Placebo-controlled Study to Investigate a Probiotic Supplement on Symptoms of Upper Respiratory Tract Infections

Registry	NCT07835100
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, prevention
Enrollment	70 (Estimated)
Sponsor	BioGaia AB (Industry)
Conditions	Upper Respiratory Tract Infection (URTI)
Interventions	Probiotic, Placebo (Other)
Dates	start 2026-09-25 (estimated), primary completion 2028-04-30 (estimated), completion 2028-04-30 (estimated), first posted 2026-09-22, last updated 2026-09-24
Locations	2 sites in Italy

-Summary

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Probiotic	Active comparator	Other: Probiotic	Probiotic oil drops formulation. Administration twice daily.
Placebo	Placebo comparator	Other: Placebo	Placebo oil drops formulation. Administration twice daily.

Probiotic (Other): Probiotic drops
Placebo (Other): Placebo drops

+Outcome measures

Primary outcomes

Number of episodes [3 months]: 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.

+Eligibility

Sex: All, ages: 4 Years to 18 Years, accepts healthy volunteers

Inclusion Criteria:

* Age 4 to18 years
* Male or female
* Healthy (no known chronic disease)
* At least 3 episodes of Upper Respiratory Tract Infection (pharyngitis and or tonsillitis, cold, rhinitis, sinusitis) in the previous year
* Written informed consent signed by both parents or caregivers

Exclusion Criteria:

* Use of antibiotics or probiotic products 2 weeks prior inclusion in the study
* Use of two or more consecutive months on antibiotics for respiratory infections on the last year
* Participation in another clinical trial
* Parents or caregivers unable to read, understand and follow the instructions

+Locations (2)

Facility	City	Country	Status
AOU Università degli Studi della Campania "Luigi Vanvitelli"	Naples	Italy
Università di Pisa	Pisa	Italy