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

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

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

Plain Language Summary

Simplified for easier understanding

This study is investigating whether taking a postbiotic supplement (a preparation of beneficial bacterial products) in the weeks before colorectal cancer surgery can improve surgical outcomes — such as reducing complications and supporting recovery. Postbiotics are different from probiotics; they contain the metabolic products of bacteria rather than live bacteria themselves. **You may be eligible if...** - You are 18 or older - You have been diagnosed with colorectal adenocarcinoma (a common type of colon or rectal cancer) - You are scheduled for planned (elective) surgery for your colon cancer - You are willing and able to provide consent to participate **You may NOT be eligible if...** - You need emergency or urgent surgery - Your surgery involves heated chemotherapy delivered directly into the abdomen (HIPEC) - You are having complex surgery for a cancer that has returned after prior treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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