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NCT Number: NCT07144475

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine, University of Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The patient or patient's family refused to be included in the study
  • Patients with chronic diseases such as HIV, uncontrolled diabetes mellitus (, uncontrolled cardiovascular disease and kidney failure
  • Patients with a history of regular probiotics, or steroids, or antibiotics consumption
  • Patients with anatomical disorders of the gastrointestinal system
  • Patients with immunocompromised conditions.

Treatment and study plan

Lactobacillus casei Shirota

Biological

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

Other names: Yakult Light

Lactobacillus acidophilus

Biological

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

Other names: Natrol Acidophilus Probiotic

Primary outcomes

  1. Gastrointestinal Function

    Time frame: Second day of treatment in the ICU

    Assessed using I-FEED score which measures postoperative gastrointestinal function that contains five elements (intake, response to nausea treatment, emesis, examination, and duration, each scored with 0, 1, or 3 points) and classifies patients into normal, postoperative gastrointestinal intolerance (POGI), and postoperative gastrointestinal dysfunction (POGD)

  2. Sepsis Incidence

    Time frame: second, fourth, and sixth days of treatment

    Assessed using NEWS2 to determine patient's degree of illness and prompts critical care intervention

  3. C-reactive protein (CRP)

    Time frame: Baseline, four hours before surgery and three days after surgery

    CRP is a protein synthesized in the liver and will increase in response to inflammation. Baseline CRP data was collected on the same day the patient visited the oncology clinic before surgery and before probiotic consumption

  4. Interleukin 6 (IL-6)

    Time frame: Baseline and three days after surgery

    IL-6 is a soluble mediator that has several functions in the immune response. IL-6 is produced in response to infection or tissue trauma. Baseline IL-6 data was collected on the same day the patient visited the oncology clinic before surgery and before probiotic consumption.

  5. Length of stay

    Time frame: Up to 16 days (documented maximum length of stay)

    The number of days of patient care after undergoing colorectal cancer surgery until the patient can be treated as an outpatient

Sponsors and collaborators

Lead sponsor

Dharmais National Cancer Center Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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