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Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery

NCT07268846 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2025-12-08

No results posted yet for this study

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)

Interventions

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.

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.

Sponsors & Collaborators

  • AC Camargo Cancer Center

    lead OTHER

Principal Investigators

  • Samuel A Junior, MD, PhD · A.C.Camargo Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2027-06-01
Completion
2027-06-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07268846 on ClinicalTrials.gov