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NCT Number: NCT07268846

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.

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Key information

Conditions

Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma) Blood Protein Disorders Breast Diseases Breast Neoplasms Cardiovascular Diseases Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Inflammation Intestinal Diseases Intestinal Neoplasms Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A.C.Camargo Cancer Center

São Paulo, 01509-010, Brazil

Location status: Recruiting

Location contact

Bruna E Catin Kupper, PhD

CONTACT

[email protected]

+55 (11) 2189-5010 ext. 2832

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Postbiotic

Dietary Supplement

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.

Placebo

Other

Participants will receive three oral capsules per day, containing no active substance and identical in appearance to the study capsules, for seven consecutive days.

Primary outcomes

  1. 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 .

Secondary outcomes

  1. 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.

  2. 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).

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bruna E Catin Kupper, PhD

CONTACT

[email protected]

+5511 2189-5010 ext. 2832

Samuel A Junior, MD, PhD

CONTACT

[email protected]

+5511 2189-5020

Sponsors and collaborators

Lead sponsor

AC Camargo Cancer Center

Other

Registry information

Official study title

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

Acronym: POSBIO-CRC

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2025
Registry last updated
Dec 8, 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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