Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery (POSBIO-CRC)

December 4, 2025 updated by: Samuel Aguiar Jr, AC Camargo Cancer Center

Randomized Clinical Trial on the Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery

The treatment of colorectal cancer, in the absence of metastases, is primarily based on surgical removal. Colorectal surgery, which involves resecting part of the intestine and restoring intestinal continuity, carries a risk of complications. This study aims to evaluate whether oral supplementation with a postbiotic at a dose of 900 mg for 7 days prior to surgery reduces the rate of postoperative complications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Recent studies have underscored the influence of gut microbiota composition on the incidence of postoperative complications following intestinal surgery. Microorganisms naturally present in the intestinal environment produce a variety of substances that may exert either beneficial or detrimental effects on human health. Emerging evidence indicates a protective role for metabolites derived from these microorganisms.

Pharmacological modulation of these metabolites for human supplementation has led to the development of postbiotics. Recent research has demonstrated that certain postbiotics, particularly short-chain fatty acids such as butyrate, possess immunomodulatory properties and contribute to maintaining the integrity of the intestinal barrier in inflammatory bowel disease.

This study will include two groups of participants: one group will receive a daily supplementation of 900 mg of butyrate, while the other will receive a placebo, for seven days prior to surgery. A total of 164 participants are expected to be enrolled, and the study will be conducted over a two-year period.

The present proposal aims to assess the effectiveness of a postbiotic in reducing postoperative complications in colorectal cancer surgery, with an anticipated 50% reduction in the overall postoperative complication rate in the intervention arm. If confirmed, such a reduction would represent a substantial decrease in morbidity and healthcare costs throughout the treatment pathway for this specific population.

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01509-010
        • Recruiting
        • A.C.Camargo Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals diagnosed with malignant neoplasm of the large intestine, specifically adenocarcinoma.
  • Patients over 18 years of age, of both sexes.
  • Patients who agree to participate in the study and sign the informed consent form.

Exclusion Criteria:

  • Emergency or urgent surgeries.
  • Cytoreductive surgeries involving intraoperative intraperitoneal chemotherapy.
  • Extended surgeries for the treatment of recurrent tumors.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo group
Participants will receive three oral capsules per day, containing no active substance and identical in appearance to the study capsules, for seven consecutive days.
Other: Placebo
Participants will receive three oral capsules per day, containing no active substance and identical in appearance to the study capsules, for seven consecutive days.
Experimental: Oral postbiotic supplementation ( Butyrate)
The formulation will contain tributyrin as the active compound, which acts directly on the large intestine. Tributyrin serves as a source of butyrate, a short-chain fatty acid. Total daily dose of 900 mg, divided into three 300 mg capsules, for seven consecutive days.
Dietary supplement: Postbiotic

Butyrate directly influences the gastrointestinal microbiota and exhibits potent anti-inflammatory effects by locally inhibiting inflammatory mediators in the intestinal epithelium, thereby enhancing mucosal barrier integrity. It also mitigates excessive inflammation through the modulation of immune cells, promoting the activity of M2 macrophages and regulatory T cells.

Furthermore, butyrate is thought to modulate intestinal receptor hypersensitivity, leading to reduced intraluminal pressure and improved peristaltic function. This mechanism may underlie its therapeutic role in clinical conditions associated with diarrhea and in preventing the loss of water, sodium, chloride, and potassium.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications within 30 days (Clavien-Dindo grade II or higher)
Time Frame: 30 days after colorectal cancer surgery
Clinical or surgical postoperative complication - Clavien-Dindo grade II or higher .
30 days after colorectal cancer surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-reactive protein (CRP) levels after surgery
Time Frame: Baseline (within 7 days before surgery) and postoperative day 3
Serum C-reactive protein (CRP) concentration (mg/L) measured preoperatively (within 7 days before surgery) and on postoperative day 3. The primary comparison will be the CRP level on postoperative day 3 between the postbiotic and control groups, as well as the change in CRP from baseline to postoperative day 3.
Baseline (within 7 days before surgery) and postoperative day 3
Gastrointestinal postoperative complications (Clavien-Dindo grade II or higher)
Time Frame: 30 days after surgery
Gastrointestinal postoperative complication : Clavien-Dindo grade II or higher within 30 days after colorectal cancer surgery (including, for example, prolonged postoperative ileus, bowel subocclusion or obstruction, anastomotic leakage, enteric fistula, intra-abdominal abscess, or gastrointestinal bleeding requiring intervention).
30 days after surgery
Nutritional status and body composition assessed by preoperative computed tomography
Time Frame: Baseline (preoperative CT scan performed within 8 weeks before surgery); postoperative complications assessed within 30 days after surgery
Preoperative body composition assessment will be performed using abdominal computed tomography scans obtained for colorectal cancer staging. Skeletal muscle area at the level of L3, skeletal muscle index (SMI), and visceral adipose tissue area will be quantified. The prevalence of sarcopenia, visceral obesity, and sarcopenic obesity will be described, and the associations between these body composition phenotypes and postoperative complications within 30 days will be explored.
Baseline (preoperative CT scan performed within 8 weeks before surgery); postoperative complications assessed within 30 days after surgery
Dietary intake assessment using a Food Frequency Questionnaire (FFQ)
Time Frame: Baseline (preoperative assessment); postoperative complications assessed within 30 days.
Habitual dietary intake will be assessed preoperatively using a validated Food Frequency Questionnaire (FFQ). Associations between identified dietary intake patterns and postoperative complications within 30 days will be explored, as well as potential interactions between habitual diet and the response to preoperative postbiotic supplementation.
Baseline (preoperative assessment); postoperative complications assessed within 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AC Camargo Cancer Center

Investigators

  • Principal Investigator: Samuel A Junior, MD, PhD, A.C.Camargo Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

December 4, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 4, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP3592/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe