Bacillus coagulans TBC169 probiotics for the recovery of intestinal function after gynecological laparoscopic surgery: a randomized, placebo-controlled trial.

Abstract

Evidence suggests that Bacillus coagulans TBC169 can improve intestinal motility. To investigate the effectiveness and safety of Bacillus coagulans TBC169 probiotics in promoting the recovery of intestinal function after gynecological laparoscopic surgery. 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). Compared to the placebo-control group, shorter FFT values were observed in the conventional-dose (23.15h vs. 29.10h, P < 0.05) and high-dose (19.15h vs. 29.10h, P < 0.001) groups. Similar trends were observed regarding TFBS in the conventional-dose (18.50h vs. 21.10h, P < 0.05) and high-dose (15.20h vs. 21.10h, P < 0.001) groups. There were no significant differences in FFT and TFBS between the intervention groups. Compared to the placebo-controlgroup, 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. 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).