Okada Keisuke, Takami Daisuke, Makizaki Yutaka, Tanaka Yoshiki, Nakajima Shunji, Ohno Hiroshi, Sagami Toru
R&D Center, Biofermin Pharmaceutical Co., Ltd., 7-3-4 Higashi-machi, Ibukidai, Nishi-ku, Kobe, Hyogo 651-2242, Japan.
Shinagawa Season Terrace Health Care Clinic, 5F, Shinagawa Season Terrace, 1-2-70 Konan, Minato-ku, Tokyo 108-0075, Japan.
Biosci Microbiota Food Health. 2023;42(3):213-221. doi: 10.12938/bmfh.2022-066. Epub 2023 Apr 6.
A placebo-controlled, randomized, double-blind study was conducted to evaluate the effect of taking 25 billion colony-forming units of heat-killed CLA8013 over 2 weeks on bowel movements in constipation-prone healthy individuals. The primary endpoint was the change in defecation frequency between the baseline and 2 weeks after the intake of CLA8013. The secondary endpoints were the number of days of defecation, stool volume, stool consistency, straining during defecation, pain during defecation, feeling of incomplete evacuation after defecation, abdominal bloating, fecal water content, and the Japanese version of the Patient Assessment of Constipation Quality of Life. A total of 120 individuals were assigned to two groups, 104 (control group, n=51; treatment group, n=53) of whom were included in the analysis. After 2 weeks of consuming the heat-killed CLA8013, defecation frequency increased significantly in the treatment group compared with that in the control group. Furthermore, compared with the control group, the treatment group showed a significant increase in stool volume and significant improvement in stool consistency, straining during defecation, and pain during defecation. No adverse events attributable to the heat-killed CLA8013 were observed during the study period. This study revealed that heat-killed CLA8013 improved the bowel movements of constipation-prone healthy individuals and confirmed that there were no relevant safety issues.
进行了一项安慰剂对照、随机、双盲研究，以评估在2周内服用250亿个热灭活CLA8013菌落形成单位对易便秘健康个体排便情况的影响。主要终点是摄入CLA8013前的基线与摄入后2周之间排便频率的变化。次要终点包括排便天数、粪便体积、粪便稠度、排便时用力情况、排便时疼痛、排便后排便不尽感、腹胀、粪便含水量以及日语版便秘患者生活质量评估。总共120名个体被分为两组，其中104名（对照组，n = 51；治疗组，n = 53）纳入分析。在食用热灭活CLA8013 2周后，治疗组的排便频率与对照组相比显著增加。此外，与对照组相比，治疗组的粪便体积显著增加，粪便稠度、排便时用力情况和排便时疼痛均有显著改善。在研究期间未观察到归因于热灭活CLA8013的不良事件。这项研究表明，热灭活CLA8013改善了易便秘健康个体的排便情况，并证实不存在相关安全问题。
