Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAC Camargo Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Emergency or urgent surgeries.

Cytoreductive surgeries involving intraoperative intraperitoneal chemotherapy.

Extended surgeries for the treatment of recurrent tumors.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Placebo groupPlacebo comparator 1 intervention
Group B: Oral postbiotic supplementation ( Butyrate)Experimental treatment 1 intervention

Trial outcomes

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 .

Time frame
30 days after colorectal cancer surgery

Secondary outcomes

1

C-reactive protein (CRP) levels after surgery

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.

Time frame
Baseline (within 7 days before surgery) and postoperative day 3
2

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

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).

Time frame
30 days after surgery
3

Nutritional status and body composition assessed by preoperative computed tomography

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.

Time frame
Baseline (preoperative CT scan performed within 8 weeks before surgery); postoperative complications assessed within 30 days after surgery
4

Dietary intake assessment using a Food Frequency Questionnaire (FFQ)

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.

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

Other outcomes

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