Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery
NCT ID: NCT07268846
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
164 participants
INTERVENTIONAL
2025-06-01
2027-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Placebo group
Participants will receive three oral capsules per day, containing no active substance and identical in appearance to the study capsules, for seven consecutive days.
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.
Oral postbiotic supplementation ( Butyrate)
The formulation will contain tributyrin as the active compound, which acts directly on the large intestine. Tributyrin serves as a source of butyrate, a short-chain fatty acid. Total daily dose of 900 mg, divided into three 300 mg capsules, for seven consecutive days.
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 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.
Interventions
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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 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
Participants will receive three oral capsules per day, containing no active substance and identical in appearance to the study capsules, for seven consecutive days.
Eligibility Criteria
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Inclusion Criteria
* 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
* Cytoreductive surgeries involving intraoperative intraperitoneal chemotherapy.
* Extended surgeries for the treatment of recurrent tumors.
18 Years
ALL
No
Sponsors
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AC Camargo Cancer Center
OTHER
Responsible Party
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Samuel Aguiar Jr
MD, PhD, Head of Colorectal Cancer Reference Center at A.C.Camargo Cancer Center
Principal Investigators
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Samuel A Junior, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
A.C.Camargo Cancer Center
Locations
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A.C.Camargo Cancer Center
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CEP3592/24
Identifier Type: -
Identifier Source: org_study_id
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