Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery

NCT07268846 | Recruiting

• 1 other identifier: CEP3592/24
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)

Keywords

Colorectal cancer surgery; Postbiotic; colorectal cancer; intestinal microbiota; nutritional intervention; inflammation

Outcome Measures

Primary Outcomes (1)

• Postoperative complications within 30 days (Clavien-Dindo grade II or higher)

  Clinical or surgical postoperative complication - Clavien-Dindo grade II or higher .

  30 days after colorectal cancer surgery

Secondary Outcomes (4)

• C-reactive protein (CRP) levels after surgery

  Baseline (within 7 days before surgery) and postoperative day 3

• Gastrointestinal postoperative complications (Clavien-Dindo grade II or higher)

  30 days after surgery

• Nutritional status and body composition assessed by preoperative computed tomography

  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)

  Baseline (preoperative assessment); postoperative complications assessed within 30 days.

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Oral postbiotic supplementation ( Butyrate)

EXPERIMENTAL

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

Interventions

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.

Oral postbiotic supplementation ( Butyrate)

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.

Placebo group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

A.C.Camargo Cancer Center

São Paulo, São Paulo, 01509-010, Brazil

RECRUITING

MeSH Terms

Conditions

Neoplasms; Colonic Neoplasms; Breast Neoplasms; Lymphoma; Multiple Myeloma; Colorectal Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Rectal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Samuel A Junior, MD, PhD

  A.C.Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel A Junior, MD, PhD

CONTACT

+5511 2189-5020; samuel.aguiar@accamargo.org.br

Bruna E Catin Kupper, PhD

CONTACT

+5511 2189-5010; bruna.catin@accamargo.org.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Head of Colorectal Cancer Reference Center at A.C.Camargo Cancer Center

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 8, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)