PMID- 35882823 OWN - NLM STAT- MEDLINE DCOM- 20221206 LR - 20221206 IS - 2210-7711 (Electronic) VI - 44 IP - 6 DP - 2022 Dec TI - Bacillus coagulans TBC169 probiotics for the recovery of intestinal function after gynecological laparoscopic surgery: a randomized, placebo-controlled trial. PG - 1287-1295 LID - 10.1007/s11096-022-01451-2 [doi] AB - 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). CI - (c) 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG. FAU - Li, Zhihong AU - Li Z AD - Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, 030032, China. AD - Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. FAU - Guan, Zhaobo AU - Guan Z AD - School of Pharmacy, Shanxi Medical University, Taiyuan, China. AD - 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. FAU - Bai, Niuniu AU - Bai N AD - School of Pharmacy, Shanxi Medical University, Taiyuan, China. AD - 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. FAU - Yan, Ya AU - Yan Y AD - School of Pharmacy, Shanxi Medical University, Taiyuan, China. AD - 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. FAU - Niu, Zhanqin AU - Niu Z AD - Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, 030032, China. AD - Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. FAU - Xu, Juan AU - Xu J AD - Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, 030032, China. AD - Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, China. FAU - Gao, Weiqi AU - Gao W AD - 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. FAU - Chen, Weihong AU - Chen W AUID- ORCID: 0000-0002-2972-1069 AD - School of Pharmacy, Shanxi Medical University, Taiyuan, China. whhchen@126.com. AD - 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. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20220727 PL - Netherlands TA - Int J Clin Pharm JT - International journal of clinical pharmacy JID - 101554912 SB - IM EIN - Int J Clin Pharm. 2022 Nov 2;:. PMID: 36323962 MH - Female MH - Humans MH - *Bacillus coagulans MH - Gynecologic Surgical Procedures/adverse effects MH - *Probiotics MH - *Laparoscopy/adverse effects MH - Recovery of Function MH - Treatment Outcome OTO - NOTNLM OT - Bacillus coagulans OT - Gynecologic laparoscopy OT - Intestinal function OT - Probiotics OT - Randomized trial EDAT- 2022/07/27 06:00 MHDA- 2022/12/07 06:00 CRDT- 2022/07/26 23:19 PHST- 2022/05/25 00:00 [received] PHST- 2022/06/22 00:00 [accepted] PHST- 2022/07/27 06:00 [pubmed] PHST- 2022/12/07 06:00 [medline] PHST- 2022/07/26 23:19 [entrez] AID - 10.1007/s11096-022-01451-2 [pii] AID - 10.1007/s11096-022-01451-2 [doi] PST - ppublish SO - Int J Clin Pharm. 2022 Dec;44(6):1287-1295. doi: 10.1007/s11096-022-01451-2. Epub 2022 Jul 27.