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

Last updated: August 24, 2025
Sponsor: Dharmais National Cancer Center Hospital
Overall Status: Completed

Phase

4

Condition

Colon Cancer; Rectal Cancer

Colorectal Cancer

Cancer

Treatment

Lactobacillus acidophilus

Lactobacillus casei Shirota

Clinical Study ID

NCT07144475
DP.04.03/11.7/020/2024
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 antibioticsconsumption

  4. Patients with anatomical disorders of the gastrointestinal system

  5. Patients with immunocompromised conditions.

Study Design

Total Participants: 90
Treatment Group(s): 2
Primary Treatment: Lactobacillus acidophilus
Phase: 4
Study Start date:
January 01, 2024
Estimated Completion Date:
March 04, 2025

Study Description

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.

Connect with a study center

  • Faculty of Medicine, University of Indonesia

    Jakarta 1642911, DKI Jakarta 10430
    Indonesia

    Site Not Available

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