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

Dharmais National Cancer Center Hospital

Status and phase: Completed; Phase 4

Conditions: Colorectal Cancer

Treatments: Biological: Lactobacillus acidophilus; Biological: Lactobacillus casei Shirota

Study type: Interventional

Funder types: Other

Identifiers

NCT07144475

DP.04.03/11.7/020/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Lactobacillus casei Shirota Group

Active Comparator group

Description:

Participants were given probiotic liquid beverage containing 6,5x10\^9 CFU of Lactobacillus casei Shirota strain

Treatment:

Biological: Lactobacillus casei Shirota

Lactobacillus acidophilus Group

Active Comparator group

Description:

Participants were given Probiotic capsule containing 10\^9 CFU of Lactobacillus acidophilus strain

Treatment:

Biological: Lactobacillus acidophilus