Probiotics for Sustained Health
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorBioGaia AB
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Probiotic
Other interventionProbiotic drops
Placebo
Other interventionPlacebo drops
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: ProbioticActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
3 months Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: