Glisic Marija, Flueck Joelle L, Ruettimann Belinda, Hertig-Godeschalk Anneke, Valido Ezra, Bertolo Alessandro, Stucki Gerold, Stoyanov Jivko
Swiss Paraplegic Research, Guido A. Zäch Strasse 4, CH-6207, Nottwil, Switzerland.
Institute of Social and Preventive Medicine (ISPM), University of Bern, Mittelstrasse 43, CH-3012, Bern, Switzerland.
Pilot Feasibility Stud. 2022 Apr 27;8(1):94. doi: 10.1186/s40814-022-01048-6.
Spinal cord injury (SCI) may cause an autonomic imbalance in the gastrointestinal tract, leading to deficits in colonic motility, mucosal secretions, vascular tone, and an increase of intestinal barrier permeability. Autonomic denervation and factors such as age, physical activity, antibiotic use and stress may cause intestinal bacterial translocation, decreased microbiota diversity, known as gut dysbiosis and thus increase susceptibility to experiencing gastrointestinal discomfort. Probiotic treatment in individuals with SCI may normalize the gut microbiota and improve overall health. We aim to assess the feasibility of probiotic and prebiotic intervention in athletes with SCI and collect information necessary for sample size calculation of a definite trial on improving health outcomes in para-athletes.
Elite Swiss para-athletes (aged> 18 years), being shortlisted for the Paralympic Games 2021 in Tokyo or a member of a national team (n = 43), will be invited to participate in this single-center randomized crossover trial. Athletes suffering from chronic inflammatory bowel diseases, those currently taking antibiotics or other medication to alleviate gastro-intestinal complaints will not be eligible to be included in the study. Athletes will be randomized (1:1) to receive for 4 weeks a daily dose of either 3 g of probiotic preparation or 5 g of prebiotic (organic oat bran) supplementation in addition to usual diet, followed by a 4-week washout period or vice versa. The primary outcome is the feasibility of the study, measured by recruitment and dropout rates, feasibility of the measurements, acceptability and adherence to the intervention. Secondary outcomes include gastrointestinal health assessment, diet and training information, handgrip strength, blood diagnostic parameters, and intestinal microbiome characterization. The changes in clinically relevant secondary outcome values will be used to make a power calculation for definite trial.
This pilot trial will address two common challenges in SCI research: the difficulty to recruit enough participants for a sufficiently powered study and the ability to collect data within the limits of a realistic budget and time frame. Upon demonstrated feasibility of the intervention and study procedures, the intervention will be evaluated in a definitive controlled trial comprising a larger sample of para-athletes (elite, engaged, or recreationally active) individuals with a SCI.
NCT04659408.
脊髓损伤（SCI）可能导致胃肠道自主神经失衡，进而引起结肠动力、黏膜分泌、血管张力方面的缺陷，并增加肠道屏障通透性。自主神经去神经支配以及年龄、身体活动、抗生素使用和压力等因素可能导致肠道细菌易位，微生物群多样性降低，即肠道生态失调，从而增加胃肠道不适的易感性。对脊髓损伤患者进行益生菌治疗可能使肠道微生物群正常化并改善整体健康状况。我们旨在评估对脊髓损伤运动员进行益生菌和益生元干预的可行性，并收集为确定改善残疾运动员健康结局的试验计算样本量所需的信息。
将邀请入围2021年东京残奥会的瑞士精英残疾运动员（年龄>18岁）或国家队成员（n = 43）参加这项单中心随机交叉试验。患有慢性炎症性肠病、目前正在服用抗生素或其他缓解胃肠道不适药物的运动员将无资格纳入本研究。运动员将被随机分组（1:1），除日常饮食外，每天接受3克益生菌制剂或5克益生元（有机燕麦麸）补充剂，持续4周，随后是4周的洗脱期，反之亦然。主要结局是研究的可行性，通过招募率和退出率、测量的可行性、干预的可接受性和依从性来衡量。次要结局包括胃肠道健康评估、饮食和训练信息、握力、血液诊断参数以及肠道微生物群特征。临床相关次要结局值的变化将用于确定试验的功效计算。
这项试点试验将解决脊髓损伤研究中的两个常见挑战：为一项有足够效力的研究招募足够参与者的困难，以及在实际预算和时间框架限制内收集数据的能力。在证明干预措施和研究程序可行后，将在一项确定性对照试验中对干预措施进行评估，该试验将纳入更大样本的患有脊髓损伤的残疾运动员（精英、现役或业余活跃）个体。
NCT04659408。
