Monocentric Crossover Study to Assess the Tolerability and the Efficacy of a Mix of Probiotic Strains Doses vs Placebo in Athletes Performance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Evaluation of physical parameters:Digestive symptoms
研究概览
简要总结
Monocentric Crossover Study to Assess the Tolerability and the Efficacy of a Mix of Probiotic Strains Doses vs Placebo in Athletes Performance
This study will intend:
- To assess the tolerability and the efficacy of a food supplements into improving performance in a panel of athletes after repeated use for 4 consecutive weeks, under the normal conditions of use, compared to a placebo.
详细描述
The present study aimed at assessing the tolerability and the efficacy of a food supplements probiotics-based (L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules) into improving performance in a panel of athletes after repeated use for 4 consecutive weeks, under the normal conditions of use, compared to a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male and Female athletes18-45 years old (included).
- •Subjects accepting to follow the instruction received by the investigator and disposable and able to return to the study centre at the established times.
- •Subjects accepting to not receive any drugs/cosmetics treatment able to interfere with the study results.
- •No participation in a similar study actually or during the previous 6 months.
- •Subjects accepting to sign the Informed consent form.
排除标准
- •1. Known sensitivity to any compound of the Investigational product.
- •Pregnant or breast feeding females or planning a pregnancy.
- •Serious intercurrent infection or other active disease up to three months prior to study entry.
- •4. History of concurrent malignancy.
- •History of significant alcohol or drug abuse.
- •Significant psycho-social or psychiatric disorders that may impair the subject's ability to meet the study requirements.
- •7. Significant concurrent medical disorders that may impair the subject's ability to participate over the whole one year of the study.
- •8. Any other medical condition which in the Investigator's opinion would prevent the subject from participating in the study.
结局指标
主要结局
Evaluation of physical parameters:Digestive symptoms
时间窗: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)
Change of the frequency of four individual digestive symptoms (abdominal pain/discomfort, bloating, flatulence/passage of gas and borborygmi/rumbling stomach) will be evaluated with five-point Likert scales that range from 0 (never) to 4 (every day of the week), between T1 and T2
Evaluation of physical parameters: fatigue
时间窗: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)
Change of Fatigue (measured by a 5-point scale) between T1 and T2
Evaluation of physical parameters: energy
时间窗: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)
Change of Energy (measured by a 5-point scale) between T1 and T2between T1 and T2
Evaluation of physical parameters: soreness
时间窗: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)
Change of Soreness (measured by a 5-point scale) between T1 and T2
Evaluation of physical parameters:Sleep quality
时间窗: at T1 (12 weeks with placebo) and T1 (12 week with ACTIVE)
Change of Sleep quality (evaluated by Sleep Quality Scale (SQS)) between T1 and T2between T1 and T2
Gut microbiota analysis ON FECAL SAMPLE by mean of 16S and metagenomic shotgun sequencing
时间窗: at T1 (12 week with ACTIVE)
16S and metagenomic shotgun sequencing
Microbial dysbiosis ON URINE SAMPLES by mean of liquid chromatography- surface-activated chemical-ionization-electrospray ionization (LC/SASI-MS) and tandem mass spectrometry (MS/MS)
时间窗: T1 (12 week with ACTIVE)
By mean of liquid chromatography bacteria that potentially could cause dysbiosis by analyzing the profile of urine's metabolites and combining the results in the SANIST platform which predicts the intestinal dysbiosis based on the antagonist and pathogen bacteria pharmacological activity
次要结局
未报告次要终点