Zhihong Li1,2, Zhaobo Guan3,4, Niuniu Bai3,4, Ya Yan3,4, Zhanqin Niu1,2, Juan Xu1,2, Weiqi Gao5, Weihong Chen6,7. 1. Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, 030032, China. 2. Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. 3. School of Pharmacy, Shanxi Medical University, Taiyuan, China. 4. Department of Pharmacy, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, 99 Longcheng Street, Taiyuan, 030032, China. 5. Department of Pharmacy, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, 99 Longcheng Street, Taiyuan, 030032, China. gaoyang0518@163.com. 6. School of Pharmacy, Shanxi Medical University, Taiyuan, China. whhchen@126.com. 7. Department of Pharmacy, Third Hospital of Shanxi Medical University, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, 99 Longcheng Street, Taiyuan, 030032, China. whhchen@126.com.
Abstract
BACKGROUND: Evidence suggests that Bacillus coagulans TBC169 can improve intestinal motility. AIM: To investigate the effectiveness and safety of Bacillus coagulans TBC169 probiotics in promoting the recovery of intestinal function after gynecological laparoscopic surgery. METHOD: Patients who underwent laparoscopic surgeries due to gynecological diseases were randomly assigned to the high-dose, conventional-dose, and the placebo-control groups (1:1:1 ratio). The primary outcome was the time to the first passage of flatus time (FFT). Secondary outcomes were the time to the first defecation (FDT), the time to the first bowel sounds (TFBS), the duration of hospital stay (DHS), and the incidence of postoperative adverse events (AEs). RESULTS: Compared to the placebo-control group, shorter FFT values were observed in the conventional-dose (23.15 h vs. 29.10 h, P < 0.05) and high-dose (19.15 h vs. 29.10 h, P < 0.001) groups. Similar trends were observed regarding TFBS in the conventional-dose (18.50 h vs. 21.10 h, P < 0.05) and high-dose (15.20 h vs. 21.10 h, P < 0.001) groups. There were no significant differences in FFT and TFBS between the intervention groups. Compared to the placebo-control group, lower incidences of postoperative adverse events were observed in the conventional-dose (12.50% vs. 40.00%, P < 0.05) and the high-dose (5.00% vs. 40.00%, P < 0.001) groups. However, there were no significant differences between these intervention groups. CONCLUSION: Bacillus coagulans TBC169 probiotics can accelerate intestinal function recovery, and reduce postoperative adverse events in patients after gynecological laparoscopic surgery. The study protocol was registered at the Chinese Clinical Trial Registry (ChiCTR2200059518).
BACKGROUND: Evidence suggests that Bacillus coagulans TBC169 can improve intestinal motility. AIM: To investigate the effectiveness and safety of Bacillus coagulans TBC169 probiotics in promoting the recovery of intestinal function after gynecological laparoscopic surgery. METHOD: Patients who underwent laparoscopic surgeries due to gynecological diseases were randomly assigned to the high-dose, conventional-dose, and the placebo-control groups (1:1:1 ratio). The primary outcome was the time to the first passage of flatus time (FFT). Secondary outcomes were the time to the first defecation (FDT), the time to the first bowel sounds (TFBS), the duration of hospital stay (DHS), and the incidence of postoperative adverse events (AEs). RESULTS: Compared to the placebo-control group, shorter FFT values were observed in the conventional-dose (23.15 h vs. 29.10 h, P < 0.05) and high-dose (19.15 h vs. 29.10 h, P < 0.001) groups. Similar trends were observed regarding TFBS in the conventional-dose (18.50 h vs. 21.10 h, P < 0.05) and high-dose (15.20 h vs. 21.10 h, P < 0.001) groups. There were no significant differences in FFT and TFBS between the intervention groups. Compared to the placebo-control group, lower incidences of postoperative adverse events were observed in the conventional-dose (12.50% vs. 40.00%, P < 0.05) and the high-dose (5.00% vs. 40.00%, P < 0.001) groups. However, there were no significant differences between these intervention groups. CONCLUSION: Bacillus coagulans TBC169 probiotics can accelerate intestinal function recovery, and reduce postoperative adverse events in patients after gynecological laparoscopic surgery. The study protocol was registered at the Chinese Clinical Trial Registry (ChiCTR2200059518).