A Multi-Center, Double-Blind, Randomized, Parallel Group Study to Evaluate the Effect of Fermented Milk Containing Lacticaseibacillus Paracasei Strain Shirota (LCS) on the Upper Airway Symptoms of Triathletes Both Before and After a Competition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Salivary IgA Concentration
研究概览
简要总结
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.
详细描述
Background:
Endurance athletes are frequently exposed to high physical stress, which may lead to temporary immune suppression and increased susceptibility to upper respiratory tract infections (URTIs). Previous studies suggest that probiotics may play a role in supporting the immune system.
Objective:
To assess the efficacy of a fermented milk drink containing Lacticaseibacillus paracasei strain Shirota (LCS) in reducing upper airway symptoms in triathletes before and after a competitive event.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study. Participants, care providers, investigators, and outcomes assessors will be blinded to group assignments to prevent bias.
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Probiotic
Participants will receive one bottle per day of fermented milk containing 40 billion colony-forming units of Lacticaseibacillus paracasei strain Shirota (LcS) for 44 days.Intervention:
Type: Dietary Supplement Name: Lacticaseibacillus paracasei strain Shirota Description: Daily intake of fermented milk containing 40 billion CFU of LcS.
干预措施: Intervention Name: Fermented milk containing Lacticaseibacillus paracasei strain Shirota. Intervention Name: Non-fermented milk (placebo) (Dietary Supplement)
Placebo Group
Name: Non-fermented milk Description: Daily intake of placebo (non-fermented milk) matched in appearance and taste to the probiotic.
干预措施: Non-fermented milk (placebo) (Dietary Supplement)
结局指标
主要结局
Salivary IgA Concentration
时间窗: 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
The primary outcome measure is the change in salivary immunoglobulin A (IgA) concentration after daily intake of fermented milk containing Lacticaseibacillus paracasei strain Shirota. Saliva samples will be collected from participants at five time points: 30 days before the competition, 24 hours before, immediately after, 72 hours after, and 14 days post-competition. The concentration of salivary IgA will be measured to assess the impact of probiotic supplementation on immune function.
次要结局
- Immune/Inflammatory Response(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)
研究者
Jonatas Bussador do Amaral
Principal Investigator
Federal University of São Paulo