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

NCT07144475 | Completed Phase 4 DMC

• 1 other identifier: DP.04.03/11.7/020/2024
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

Probiotics; Lactobacillus casei Shirota; Lactobacillus acidophilus; Colorectal cancer; Surgical outcomes

Outcome Measures

Primary Outcomes (5)

• Gastrointestinal Function

  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)

  Second day of treatment in the ICU

• Sepsis Incidence

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

  second, fourth, and sixth days of treatment

• C-reactive protein (CRP)

  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

  Baseline, four hours before surgery and three days after surgery

• Interleukin 6 (IL-6)

  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.

  Baseline and three days after surgery

• Length of stay

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

  Up to 16 days (documented maximum length of stay)

Study Arms (2)

Lactobacillus casei Shirota Group

ACTIVE COMPARATOR

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

Biological: Lactobacillus casei Shirota

Lactobacillus acidophilus Group

ACTIVE COMPARATOR

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

Biological: Lactobacillus acidophilus

Interventions

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.

Also known as: Yakult Light

Lactobacillus casei Shirota Group

Lactobacillus acidophilus BIOLOGICAL

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

Also known as: Natrol Acidophilus Probiotic

Lactobacillus acidophilus Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dharmais National Cancer Center Hospital: lead

Study Sites (1)

Faculty of Medicine, University of Indonesia

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (11)

• 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.

  PMID: 27073082 BACKGROUND

• 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.

  PMID: 23571641 BACKGROUND

• 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.

  PMID: 35371356 BACKGROUND

• 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.

  PMID: 34220758 BACKGROUND

• 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.

  PMID: 32435475 BACKGROUND

• 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.

  PMID: 16899663 BACKGROUND

• 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.

  PMID: 31363895 BACKGROUND

• 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.

  PMID: 27098538 BACKGROUND

• 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.

  PMID: 33922897 BACKGROUND

• 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.

  PMID: 36431045 BACKGROUND

• 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.

  PMID: 35464397 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Lacteol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Berial D Marzaini, MD

  Faculty of Medicine, University of Indonesia

  PRINCIPAL INVESTIGATOR

• Dita Aditianingsih, Professor

  Faculty of Medicine, University of Indonesia

  STUDY CHAIR

• Arif HM Marsaban, MD

  Faculty of Medicine, University of Indonesia

  STUDY CHAIR

• Gardian L Hakim, MD

  Dharmais Cancer Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 27, 2025
• Study Start: January 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: March 4, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)