NCT07144475

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

Comparison of Probiotic Effects of Lactobacillus Casei Shirota With Lactobacillus Acidophilus on the Outcomes of Patients After Colorectal Cancer Surgery: A Study of Gastrointestinal Function, Sepsis Incidence, C-Reactive Protein, Interleukin 6 and Length of Stay

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Dharmais National Cancer Center Hospital · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Lactobacillus casei Shirota	Consumption of Lactobacillus casei Shirota three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.
BIOLOGICAL	Lactobacillus acidophilus	Consumption of Lactobacillus acidophilus three times daily for three days before surgery at 6 AM, 2 PM and 10 PM.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-11-30
• Completion: 2025-03-04
• First posted: 2025-08-27
• Last updated: 2025-08-27

Locations

1 site across 1 country: Indonesia