Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Postbiotic, Placebo.
- Who it may be relevant to
- Registry conditions: Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Clinical Trial on the Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery
Overview
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.
Detailed description
Recent studies have underscored the influence of gut microbiota composition on the incidence of postoperative complications following intestinal surgery. Microorganisms naturally present in the intestinal environment produce a variety of substances that may exert either beneficial or detrimental effects on human health. Emerging evidence indicates a protective role for metabolites derived from these microorganisms.
Pharmacological modulation of these metabolites for human supplementation has led to the development of postbiotics. Recent research has demonstrated that certain postbiotics, particularly short-chain fatty acids such as butyrate, possess immunomodulatory properties and contribute to maintaining the integrity of the intestinal barrier in inflammatory bowel disease.
This study will include two groups of participants: one group will receive a daily supplementation of 900 mg of butyrate, while the other will receive a placebo, for seven days prior to surgery. A total of 164 participants are expected to be enrolled, and the study will be conducted over a two-year period.
The present proposal aims to assess the effectiveness of a postbiotic in reducing postoperative complications in colorectal cancer surgery, with an anticipated 50% reduction in the overall postoperative complication rate in the intervention arm. If confirmed, such a reduction would represent a substantial decrease in morbidity and healthcare costs throughout the treatment pathway for this specific population.
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 an - 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.
Primary outcome measures
- Postoperative complications within 30 days (Clavien-Dindo grade II or higher) [Time frame: 30 days after colorectal cancer surgery]
Secondary outcome measures (4)
- C-reactive protein (CRP) levels after surgery [Time frame: Baseline (within 7 days before surgery) and postoperative day 3]
- Gastrointestinal postoperative complications (Clavien-Dindo grade II or higher) [Time frame: 30 days after surgery]
- Nutritional status and body composition assessed by preoperative computed tomography [Time frame: 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) [Time frame: Baseline (preoperative assessment); postoperative complications assessed within 30 days.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- Emergency or urgent surgeries.
- Cytoreductive surgeries involving intraoperative intraperitoneal chemotherapy.
- Extended surgeries for the treatment of recurrent tumors.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Brazil · 1 center
- A.C.Camargo Cancer Center — São Paulo
Identifiers
NCT: NCT07268846 · CEP3592/24