International Journal of Clinical Pharmacy ( IF 2.4 ) Pub Date : 2022-07-27 , DOI: 10.1007/s11096-022-01451-2 Zhihong Li 1, 2 , Zhaobo Guan 3, 4 , Niuniu Bai 3, 4 , Ya Yan 3, 4 , Zhanqin Niu 1, 2 , Juan Xu 1, 2 , Weiqi Gao 4 , Weihong Chen 3, 4
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).