Bacillus coagulans TBC169 probiotics for intestinal function recovery after gynecological open surgery: a randomized, double-blind, placebo-controlled trial.

Background: Restoration of intestinal function after open surgery remains a significant challenge in gynecological practice. Bacillus coagulans TBC169 probiotics may enhance intestinal motility and recovery.

Aim: This randomized controlled trial aimed to evaluate the efficacy and safety of Bacillus coagulans TBC169 in promoting intestinal function recovery after gynecological open abdominal surgery.

Method: Patients undergoing open surgery were randomly assigned to high-dose (HDG), conventional-dose (CDG), or placebo-controlled (PCG) groups. The primary outcome was the time to first flatus (TFF). Secondary outcomes included time to first defecation (TFD), time to first bowel sounds (TFBS), duration of hospital stay (DHS), and postoperative complication rate (PCR).

Results: A total of 114 patients were included, with 38 patients allocated to each group. TFF was significantly shorter in the CDG (25.8 h vs. 38.1 h, P < 0.001) and the HDG (23.1 h vs. 38.1 h, P < 0.001) than the PCG. TFBS was significantly reduced in the CDG (16.1 h vs. 19.3 h, P < 0.05) and the HDG (14.3 h vs. 19.3 h, P < 0.001). Patients in the HDG had a significantly shorter TFD than the PCG (61.2 h vs. 66.4 h, P < 0.05). However, DHS did not differ significantly among the groups. PCR was markedly lower in the CDG (34.2% vs. 68.4%, P < 0.01) and HDG (21.1% vs. 68.4%, P < 0.001) compared to the PCG. No adverse events were reported across the groups.

Conclusion: Bacillus coagulans TBC169 accelerates intestinal function recovery and reduces postoperative complications following gynecologic open surgery.

Trial registration: The study protocol was registered with the China Clinical Trials Registry (ChiCTR2200059518).