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NCT Number: NCT07835100

Probiotics for Sustained Health

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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Key information

Conditions

Upper Respiratory Tract Infection (URTI) Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOU Università degli Studi della Campania "Luigi Vanvitelli", Naples, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Other

Probiotic drops

Placebo

Other

Placebo drops

Primary outcomes

  1. Number of episodes

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

BioGaia AB

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 22, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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