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Starting soon Not applicable

Probiotics for Sustained Health

NCT07835100 · tracked via the Priya Life Science Italy tracker
Sponsor
Phase
Not applicable
Started
2026-09-25
Last updated
2026-09-24

Condition(s) studied

Upper Respiratory Tract Infection (URTI)

Investigational drug(s) / intervention(s)

ProbioticPlacebo

Probiotic: Probiotic drops

Placebo: Placebo drops

Study 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.

Eligibility

Sex
ALL
Min age
4 Years
Max age
18 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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.

Trial sites (2)

FacilityCityRegionStatus
AOU Università degli Studi della Campania "Luigi Vanvitelli" Naples Italy
Università di Pisa Pisa Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07835100 on ClinicalTrials.gov ↗ ← All trials in Italy