Evaluation of the Clinical Efficacy of Antrrix Probiotics in Improving Recurrent Respiratory Infections in Infants and Young Children

Condition(s) studied

Investigational drug(s) / intervention(s)

Probiotic: Daily 2 × 10 9 CFU per 6 drops containing Lactobacillus rhamnosus CRL1505+Bifidobacterium brevis M-16V strain in MCT oil

Placebo: Daily 6 drops MCT oil without probiotics

Study summary

This study is an 8-weeks, randomized controlled trial involving children under 6 years of age who meet clinical diagnostic criteria for RRTI. Participants are randomized to receive either probiotic or placebo. The primary clinical outcomes assessed are duration and frequency of respiratory symptoms and quality of life. To investigate potential mechanisms, stool samples were collected pre- and post-intervention for metagenomics gene sequencing to analyze changes in gut microbiota composition and identify specific bacterial taxa associated with clinical improvements.

Eligibility

Primary outcome measure(s)

• Respiratory symptoms in children upon administration of probiotic or placebo as assessed via clinical questionnaire — day 1, day 7, day 14, week 4, week 8
  Differences in severity of respiratory symptoms in children upon administration of probiotic or placebo, assessed using a hospital-based clinical questionnaire scored on a 5-point ordinal scale (0 = no symptoms to 4 = severe symptoms), with lower scores indicating better respiratory status.

Trial sites (2)

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