The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Comfort in Elite Athletes with Spinal Cord Injury: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Severe adverse events
研究概览
简要总结
The main objective of this pilot study is to obtain information, which will be used for the design of a main randomized controlled trial (RCT) with a larger size based on feasibility, validity and sample size estimation as well as the potential effects of pre- and probiotic intake on intestinal microbiota. A larger trial will then be designed to test the hypothesis that adding probiotics or prebiotics may improve gut microbiome composition, gastrointestinal symptoms as well as cardiometabolic health indices in mid-term and possibly lead to improved sports performance over a longer-term period in athletes with a Spinal Cord Injury.
详细描述
In this pilot crossover randomized controlled trial, twenty (N = 20) para-athletes will participate in an intervention consisting of a four-week intake of probiotic, using the commercially available multistrain probiotic preparation "BactoSan pro FOS" from Mepha (Basel, Switzerland), followed by a four-week wash-out period, and a four-week prebiotic intervention using "Naturaplan Bio Oat Bran" (Coop, Switzerland). Total duration of the study will be 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •athletes with a spinal cord injury shortlisted as potential participants for major international events, such as the Paralympic Games 2021 in Tokyo and World Championship qualification
排除标准
- •Chronic inflammatory bowel diseases (i.e. ulcerative colitis, Crohn's disease)
- •Taking antibiotics and/or other medication to alleviate gastrointestinal complaints at recruitment time point
- •Pregnancy
结局指标
主要结局
Severe adverse events
时间窗: Through study completion, an average of 4 months
The occurrence of severe adverse events (SAEs)
Recruitment rate
时间窗: At baseline
Proportion of invited participants who agreed to participate in the trial
Dropout rate
时间窗: Through study completion, an average of 4 months
The proportion of randomized participants who did not complete the study protocol
次要结局
- Monitoring of inflammation(At 0, 1, 2, 3 months)
- Stool microbiome characterization(At 0, 1, 2, 3 months)
- Loss of training days due to injury or illness(At 0, 1, 2, 3 months)
- Gastrointestinal problems(At 0, 1, 2, 3 months)
- Food intake during three days(At 0, 1, 2, 3 months)
- Recording of leisure time activity(At 0, 1, 2, 3 months)