Rea K, Colom J, Simon E A, Khokhlova E, Mazhar S, Barrena M, Enrique M, Martorell P, Perez B Alvarez, Tortajada M, Phipps C, Deaton J
Deerland Ireland R&D Ltd./ADM, Food Science Building, University College Cork, Cork T12 YT20, Ireland.
ADM Biopolis, Parc Cientific Universitat de Valencia, Catadratico Agustin Escardino Benlloch, 9. Edificio 2, 46980 Paterna, Spain.
Benef Microbes. 2023 Apr 18;14(2):165-182. doi: 10.3920/BM2022.0117. Epub 2023 Apr 7.
In the present study, the safety, tolerance and impact of 1×10 cfu CSI08, 1×10 cfu MIT411 and a probiotic cocktail containing DE111, MIT411, CGI314, and CSI08 with a total count of 2.0×10 cfu administered daily were assessed as compared with a maltodextrin containing placebo control. A total of 98 study participants received daily doses for 45 days, followed by a washout period of 2 weeks. A questionnaire to capture the incidence and duration of upper respiratory tract, urinary tract and/or gastrointestinal complaints and a diary to capture stool regularity and consistency was kept daily to record compliance throughout the 45 days. Faecal and blood samples were collected for microbiological and haematological analysis at the start and end of the treatment period. The probiotic cocktail significantly decreased the incidence of loose stools throughout the entire study. The recorded respiratory, urinary and gastrointestinal symptoms, defecation frequency and other stool consistency were not influenced. No clinically relevant changes in blood parameters, such as liver and kidney function and no serious adverse events appeared during and after administration. There were no changes in symptoms including sadness, irritability, energy, appetite, tension, stress, sleep, cardiovascular events, aches and pains, and dizziness as determined by a mood questionnaire administered to participants at baseline and at the end of the treatment period. Similarly, the measured inflammatory cytokines, antioxidant levels, cholesterol, triglycerides, free amino acids or minerals remained unaffected. There were no negative changes in alpha or beta diversity of the microbiota with any of the treatment groups. These promising data suggest that these treatments were safe and well tolerated, and further work with larger cohorts are justified to determine the efficacy of these potential probiotics in select demographic groups. Trial registration number with clinicaltrials.gov at NCT04758845.
在本研究中，评估了每日服用1×10 cfu CSI08、1×10 cfu MIT411以及含有DE111、MIT411、CGI314和CSI08且总数为2.0×10 cfu的益生菌混合物的安全性、耐受性及其影响，并与含麦芽糊精的安慰剂对照组进行比较。共有98名研究参与者每天服用剂量，持续45天，随后是2周的洗脱期。每天使用一份问卷来记录上呼吸道、泌尿道和/或胃肠道不适的发生率和持续时间，并使用一本日记来记录大便的规律性和稠度，以记录整个45天期间的依从性。在治疗期开始和结束时采集粪便和血液样本进行微生物学和血液学分析。在整个研究过程中，益生菌混合物显著降低了腹泻的发生率。记录的呼吸、泌尿和胃肠道症状、排便频率及其他大便稠度均未受影响。给药期间及之后，血液参数如肝肾功能没有出现临床相关变化，也没有严重不良事件发生。根据在基线和治疗期结束时对参与者进行的情绪问卷调查，包括悲伤、易怒感、精力、食欲、紧张、压力、睡眠、心血管事件、疼痛和头晕等症状均无变化。同样，所测量的炎性细胞因子、抗氧化剂水平、胆固醇、甘油三酯、游离氨基酸或矿物质均未受影响。任何治疗组的微生物群的α或β多样性均未出现负面变化。这些有前景的数据表明这些治疗方法安全且耐受性良好，因此有理由开展更大规模队列的进一步研究，以确定这些潜在益生菌在特定人群中的疗效。试验在clinicaltrials.gov上的注册号为NCT04758845。
