Preoperative postbiotic (butyrate) given before colorectal cancer surgery
Randomized Clinical Trial on the Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery
This trial will test whether taking a 900 mg daily postbiotic (butyrate) for seven days before elective colorectal cancer surgery helps reduce postoperative complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AC Camargo Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT07268846 on ClinicalTrials.gov |
What this trial studies
Participants with localized colorectal adenocarcinoma scheduled for elective resection will be assigned to one of two groups to receive either 900 mg of oral butyrate daily or a matching placebo for seven days prior to surgery. The study plans to enroll 164 participants over about two years at A.C. Camargo Cancer Center and will compare postoperative complication rates between the two groups. The rationale is based on evidence that microbially derived metabolites such as short-chain fatty acids can modulate immunity and support intestinal barrier integrity. The trial aims to determine whether short-term preoperative supplementation can translate these effects into fewer surgical complications.
Who should consider this trial
Good fit: Adults over 18 with confirmed colorectal adenocarcinoma scheduled for elective (non-emergency) intestinal resection who can provide informed consent are the intended participants.
Not a fit: Patients undergoing emergency or urgent surgery, cytoreductive operations with intraoperative intraperitoneal chemotherapy, or extended procedures for recurrent tumors are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, this simple preoperative supplement could substantially lower postoperative complications, reduce morbidity, and decrease related healthcare costs.
How similar studies have performed: Preclinical work and some clinical data suggest short-chain fatty acids like butyrate support gut barrier function and modulate immunity, but randomized clinical evidence showing reduced postoperative complications after preoperative postbiotic use is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo, São Paulo
- A.C.Camargo Cancer Center — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Samuel A Junior, MD, PhD — A.C.Camargo Cancer Center
- Study coordinator: Samuel A Junior, MD, PhD
- Email: samuel.aguiar@accamargo.org.br
- Phone: +5511 2189-5020
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.