Comparison of Probiotic Effects on the Outcomes of Patients After Colorectal Cancer Surgery

NCT ID: NCT07144475

Last Updated: 2025-08-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-03-04

Brief Summary

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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.

Detailed Description

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The research design was a two-group unblinded, randomized clinical trial in 90 adult patients undergoing colorectal cancer surgery who are treated in the ICU, HCU and wards of Dharmais Cancer Hospital. Subjects who meet the criteria are divided into 2 (two) groups: the group given Lactobacillus casei Shirota and Lactobacillus acidophilus probiotics. Assessment of gastrointestinal function using the I-FEED score for early feeding was carried out on the second day after surgery. Sepsis diagnosis used the NEWS2 scoring assessed on the second, fourth, and sixth days of treatment. CRP levels were measured three times, namely during perioperative visit before surgery, four hours before surgery and three days after surgery. IL-6 levels were measured twice, namely perioperative visit before surgery and three days after surgery. Length of stay was calculated from after surgery until the patient was discharged.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

Lactobacillus casei Shirota

Intervention Type BIOLOGICAL

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

Group Type ACTIVE_COMPARATOR

Lactobacillus acidophilus

Intervention Type BIOLOGICAL

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.

Intervention Type BIOLOGICAL

Lactobacillus acidophilus

Consumption of Lactobacillus acidophilus three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.

Intervention Type BIOLOGICAL

Other Intervention Names

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Yakult Light Natrol Acidophilus Probiotic

Eligibility Criteria

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Inclusion Criteria

1\. Patients who were diagnosed with colorectal cancer and would undergo resection surgery at Dharmais Cancer Hospital

Exclusion Criteria

1. The patient or patient's family refused to be included in the study
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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dharmais National Cancer Center Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Berial Dewin Marzaini

Principal Investigator

Responsibility Role 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

Site Status

Countries

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Indonesia

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.

Reference Type BACKGROUND
PMID: 27073082 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23571641 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35371356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34220758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32435475 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16899663 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31363895 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27098538 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33922897 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36431045 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35464397 (View on PubMed)

Other Identifiers

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DP.04.03/11.7/020/2024

Identifier Type: -

Identifier Source: org_study_id

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