RecruitingNot ApplicableNCT07268846

Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery

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


Sponsor

AC Camargo Cancer Center

Enrollment

164 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

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

Interventions

DIETARY_SUPPLEMENTPostbiotic

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.

OTHERPlacebo

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


Locations(1)

A.C.Camargo Cancer Center

São Paulo, São Paulo, Brazil

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NCT07268846


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