Идёт набор NCT07268846

Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery

Без фазы С лечением Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Postbiotic, Placebo.
Кому может быть актуально: Состояния в реестре: Cancer (Colon Cancer, Breast Cancer, Lymphoma, Chronic Lymphoma Leukemia, Multiple Myeloma). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Бразилия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

Пищевая добавка 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
Другое 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.

Первичные конечные точки

Postoperative complications within 30 days (Clavien-Dindo grade II or higher) [Срок оценки: 30 days after colorectal cancer surgery]

Вторичные конечные точки (4)

C-reactive protein (CRP) levels after surgery [Срок оценки: Baseline (within 7 days before surgery) and postoperative day 3]
Gastrointestinal postoperative complications (Clavien-Dindo grade II or higher) [Срок оценки: 30 days after surgery]
Nutritional status and body composition assessed by preoperative computed tomography [Срок оценки: 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) [Срок оценки: Baseline (preoperative assessment); postoperative complications assessed within 30 days.]

Критерии участия

Критерии включения

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.