A Pilot Study; a Randomized Double-blind Placebo-controlled Study to Investigate a Probiotic Supplement on Symptoms of Upper Respiratory Tract Infections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- BioGaia AB
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Number of episodes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 4 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Placebo
Placebo oil drops formulation. Administration twice daily.
Intervention: Placebo (Other)
Probiotic
Probiotic oil drops formulation. Administration twice daily.
Intervention: Probiotic (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported