drugset / Trial / NCT07144475
Comparison of Probiotic Effects on the Outcomes of Patients After Colorectal Cancer Surgery
RandomizedParallel-groupOpen-labelOther
Summary
This clinical trial aims to compare the effects of administering Lactobacillus casei Shirota probiotics with Lactobacillus acidophilus on the outcomes of patients after colorectal cancer surgery. Researchers will compare probiotic to see if Lactobacillus casei Shirota improves gastrointestinal function, sepsis incidence, C-reactive protein (CRP), interleukin 6 (IL-6), and length of stay better than Lactobacillus acidophilus. Participants will take probiotics three times daily for three days before surgery.
Timeline
- Start
- 2024-01-01
- Primary completion
- 2024-11-30
- Completion
- 2025-03-04
Publications
- Background Arumugam S, Lau CS, Chamberlain RS. Probiotics and Synbiotics Decrease Postoperative Sepsis in Elective Gastrointestinal Surgical Patients: a Meta-Analysis. J Gastrointest Surg. 2016 Jun;20(6):1123-31. doi: 10.1007/s11605-016-3142-y. Epub 2016 Apr 12.
- Background Khailova L, Frank DN, Dominguez JA, Wischmeyer PE. Probiotic administration reduces mortality and improves intestinal epithelial homeostasis in experimental sepsis. Anesthesiology. 2013 Jul;119(1):166-77. doi: 10.1097/ALN.0b013e318291c2fc.
- Background Mulita F, Liolis E, Akinosoglou K, Tchabashvili L, Maroulis I, Kaplanis C, Vailas M, Panos G. Postoperative sepsis after colorectal surgery: a prospective single-center observational study and review of the literature. Prz Gastroenterol. 2022;17(1):47-51. doi: 10.5114/pg.2021.106083. Epub 2021 May 23.
- Background Bai Y, Huang Y, Li Y, Zhang B, Xiao C, Hou X, Yu L. The Murine Reg3a Stimulated by Lactobacillus casei Promotes Intestinal Cell Proliferation and Inhibits the Multiplication of Porcine Diarrhea Causative Agent in vitro. Front Microbiol. 2021 Jun 18;12:675263. doi: 10.3389/fmicb.2021.675263. eCollection 2021.
- Background Pak H, Maghsoudi LH, Soltanian A, Gholami F. Surgical complications in colorectal cancer patients. Ann Med Surg (Lond). 2020 May 11;55:13-18. doi: 10.1016/j.amsu.2020.04.024. eCollection 2020 Jul.
- Background Shida K, Kiyoshima-Shibata J, Nagaoka M, Watanabe K, Nanno M. Induction of interleukin-12 by Lactobacillus strains having a rigid cell wall resistant to intracellular digestion. J Dairy Sci. 2006 Sep;89(9):3306-17. doi: 10.3168/jds.S0022-0302(06)72367-0.
- Background Alsharqawi N, Alhashemi M, Kaneva P, Baldini G, Fiore JF Jr, Feldman LS, Lee L. Validity of the I-FEED score for postoperative gastrointestinal function in patients undergoing colorectal surgery. Surg Endosc. 2020 May;34(5):2219-2226. doi: 10.1007/s00464-019-07011-6. Epub 2019 Jul 30.
- Background Tan CK, Said S, Rajandram R, Wang Z, Roslani AC, Chin KF. Pre-surgical Administration of Microbial Cell Preparation in Colorectal Cancer Patients: A Randomized Controlled Trial. World J Surg. 2016 Aug;40(8):1985-92. doi: 10.1007/s00268-016-3499-9.
- Background Pitsillides L, Pellino G, Tekkis P, Kontovounisios C. The Effect of Perioperative Administration of Probiotics on Colorectal Cancer Surgery Outcomes. Nutrients. 2021 Apr 25;13(5):1451. doi: 10.3390/nu13051451.
- Background Qin D, Ma Y, Wang Y, Hou X, Yu L. Contribution of Lactobacilli on Intestinal Mucosal Barrier and Diseases: Perspectives and Challenges of Lactobacillus casei. Life (Basel). 2022 Nov 16;12(11):1910. doi: 10.3390/life12111910.
- Background Dempsey E, Corr SC. Lactobacillus spp. for Gastrointestinal Health: Current and Future Perspectives. Front Immunol. 2022 Apr 6;13:840245. doi: 10.3389/fimmu.2022.840245. eCollection 2022.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lactobacillus acidophilus | Other / unclassified | 1e+09 unknown | — |
| Comparator | Lactobacillus casei Shirota | Other / unclassified | 6.5e+09 unknown | — |