Probiotics for Sustained Health
A Pilot Study; a Randomized Double-blind Placebo-controlled Study to Investigate a Probiotic Supplement on Symptoms of Upper Respiratory Tract Infections
1 other identifier
interventional
70
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2026
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2026
CompletedFirst Posted
Study publicly available on registry
September 22, 2026
CompletedStudy Start
First participant enrolled
September 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
September 24, 2026
September 1, 2026
1.6 years
September 17, 2026
September 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Study Arms (2)
Probiotic
ACTIVE COMPARATORProbiotic oil drops formulation. Administration twice daily.
Placebo
PLACEBO COMPARATORPlacebo oil drops formulation. Administration twice daily.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioGaia ABlead
Study Sites (2)
AOU Università degli Studi della Campania "Luigi Vanvitelli"
Naples, 80138, Italy
Università di Pisa
Pisa, 56126, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2026
First Posted
September 22, 2026
Study Start
September 25, 2026
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
April 30, 2028
Last Updated
September 24, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share