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).
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Change history
02 November 2022
A Correction to this paper has been published: https://doi.org/10.1007/s11096-022-01499-0
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Authors are grateful to all participants and gynecologists who participated in this study.
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The original online version of this article was revised: Font of “Impact statements” and heading sizes for ‘Aim’ and ‘Ethics approval’ are incorrect. ‘Conflict of interest’ should be ‘Conflicts of interest’. In Table 1, ‘Type of surgery, n (5)’ should be ‘Type of surgery, n (%)’. Reference 25 should have three authors “Hong HA, Duc le H, Cutting SM”. These errors have been corrected.
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Li, Z., Guan, Z., Bai, N. et al. Bacillus coagulans TBC169 probiotics for the recovery of intestinal function after gynecological laparoscopic surgery: a randomized, placebo-controlled trial. Int J Clin Pharm 44, 1287–1295 (2022). https://doi.org/10.1007/s11096-022-01451-2
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DOI: https://doi.org/10.1007/s11096-022-01451-2