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Life sciences · Interventional Study
ClinicalTrials.gov · October 15, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06970964). This is a study registration, not published results. Lead sponsor: Federal University of São Paulo. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 80 participants (ACTUAL). Conditions: Respiratory Tract Infections (RTI), Mucosal Immunity, Systemic Inflammation, Depressive Disorder, Exercise-Induced Immunosuppression, Athletic Performance, Upper Respiratory Tract Symptoms, Mental Health, Cytokine Response, Probiotic Therapy. Interventions: DIETARY_SUPPLEMENT: Intervention Name: Fermented milk containing Lacticaseibacillus paracasei strain Shirota. Intervention Name: Non-fermented milk (placebo); DIETARY_SUPPLEMENT: Non-fermented milk (placebo). Primary outcome measures: Salivary IgA Concentration , Pre-study: 30 days before the competition (baseline) During study: 24 hours before the competition Post-study: Immediately after the competition, 72 hours post-competition, and 14 days after the competition. Brief summary: This study aims to evaluate whether a fermented milk drink containing the probiotic strain Lacticaseibacillus paracasei strain Shirota (LCS), commonly found in Yakult®, can help reduce upper respiratory symptoms in triathletes before and after competition. Athletes often experience cold-like symptoms due to physical stress, intense training, and immune system challenges. The study investigates whether daily consumption of this probiotic drink can help improve immune response and reduce the incidence or severity of symptoms such as sore throat, nasal congestion, or coughing. This is a randomized, double-blind, placebo-controlled, parallel-group study involving healthy adult triathletes. Participants will be randomly assigned to receive either the probiotic drink or a placebo for a specific period before and after a triathlon event. Symptoms and health markers will be tracked through questionnaires and biological samples. The goal is to explore whether probiotic supplementation can provide practical, non-pharmacological support for athletes' immune health and well-being during intense physical activity.