Comparison of Probiotic Effects on the Outcomes of Patients After Colorectal Cancer Surgery
NCT ID: NCT07144475
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
90 participants
INTERVENTIONAL
2024-01-01
2025-03-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Lactobacillus casei Shirota Group
Participants were given probiotic liquid beverage containing 6,5x10\^9 CFU of Lactobacillus casei Shirota strain
Lactobacillus casei Shirota
Consumption of Lactobacillus casei Shirota three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.
Lactobacillus acidophilus Group
Participants were given Probiotic capsule containing 10\^9 CFU of Lactobacillus acidophilus strain
Lactobacillus acidophilus
Consumption of Lactobacillus acidophilus three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.
Interventions
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Lactobacillus casei Shirota
Consumption of Lactobacillus casei Shirota three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.
Lactobacillus acidophilus
Consumption of Lactobacillus acidophilus three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Patients with chronic diseases such as HIV, uncontrolled diabetes mellitus (, uncontrolled cardiovascular disease and kidney failure
3. Patients with a history of regular probiotics, or steroids, or antibiotics consumption
4. Patients with anatomical disorders of the gastrointestinal system
5. Patients with immunocompromised conditions.
18 Years
65 Years
ALL
No
Sponsors
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Dharmais National Cancer Center Hospital
OTHER_GOV
Responsible Party
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Berial Dewin Marzaini
Principal Investigator
Principal Investigators
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Berial D Marzaini, MD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, University of Indonesia
Dita Aditianingsih, Professor
Role: STUDY_CHAIR
Faculty of Medicine, University of Indonesia
Arif HM Marsaban, MD
Role: STUDY_CHAIR
Faculty of Medicine, University of Indonesia
Gardian L Hakim, MD
Role: STUDY_CHAIR
Dharmais Cancer Hospital
Locations
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Faculty of Medicine, University of Indonesia
Jakarta, DKI Jakarta, Indonesia
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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DP.04.03/11.7/020/2024
Identifier Type: -
Identifier Source: org_study_id
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