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Search / Trial NCT06970964

Fermented Milk Drink With Lacticaseibacillus Paracasei Strain Shirota Helps Triathletes With Cold-Like Symptoms Before and After a Race

Launched by FEDERAL UNIVERSITY OF SÃO PAULO · May 9, 2025

Trial Information

Current as of July 22, 2025

Not yet recruiting

Keywords

Immune Function Sports Nutrition Endurance Athletes Lacticaseibacillus Paracasei Strain Shirota Upper Respiratory Symptoms Respiratory Tract Infections Immunity Mucosal Inflammation Probiotics Exercise

ClinConnect Summary

This clinical trial is studying whether a special fermented milk drink containing a probiotic called Lacticaseibacillus paracasei strain Shirota (found in Yakult®) can help triathletes who often experience cold-like symptoms, such as sore throat and nasal congestion, especially before and after races. Athletes can face immune challenges due to the physical stress of training and competition, and the researchers want to see if this drink can improve their immune response and reduce these symptoms.

To participate, you need to be an amateur triathlete aged between 25 and 45 years, in good health, and free from chronic conditions that could affect your immune system. Participants will be randomly assigned to drink either the probiotic drink or a placebo (a drink with no active ingredients) for 30 days before and 14 days after a triathlon. Throughout the study, your health will be monitored through questionnaires and biological samples. This trial aims to find out if this probiotic drink can be a helpful, non-drug option for supporting athletes' immune health during intense physical activities.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Aged between 25 and 45 years.
  • Amateur triathletes with regular endurance training and prior competition experience.
  • In good general health, with no history of chronic diseases or conditions affecting immune or inflammatory responses.
  • Willing and able to comply with all study procedures, including sample collections and completion of validated questionnaires at five time points.
  • Agree to consume a daily dose of fermented milk containing Lacticaseibacillus paracasei strain Shirota (LcS) or placebo from 30 days before until 14 days after the competition.
  • No use of probiotics, antibiotics, or immunomodulatory supplements in the 30 days prior to enrollment
  • Exclusion Criteria:
  • Known allergy or intolerance to dairy products, including lactose.
  • Use of probiotics or antibiotics within 30 days prior to enrollment.
  • Current use of any pharmacological treatment.
  • History of chronic rhinopathy.
  • Diagnosis of autoimmune disease.
  • History of recurrent infections not involving the upper airway.
  • Presence of major medical conditions or chronic diseases, including but not limited to respiratory or gastrointestinal disorders.
  • Incomplete or missing data necessary for determining eligibility or for study outcomes.

About Federal University Of São Paulo

The Federal University of São Paulo (Universidade Federal de São Paulo - UNIFESP) is a prestigious institution dedicated to advancing education, research, and healthcare in Brazil. Renowned for its commitment to innovation and excellence, UNIFESP plays a pivotal role in clinical research, focusing on a multidisciplinary approach to improve health outcomes. The university fosters collaboration among researchers, healthcare professionals, and community stakeholders, ensuring that clinical trials conducted under its auspices adhere to rigorous ethical standards and contribute valuable insights to the medical field. With a rich history of academic achievement and a strong emphasis on translational research, UNIFESP is a key player in the development of new therapies and medical interventions.

Locations

Sao Paulo, , Brazil

Patients applied

0 patients applied

Trial Officials

Jonatas B do Amaral, PHD

Principal Investigator

Federal University of São Paulo

André Luis L Bachi, PHD

Study Chair

Santo Amaro University

Cesar Miguel M dos Santos, PHD

Study Chair

Enau College

Mauro W Vaisberg, PHD

Study Chair

Federal University of São Paulo

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported