Preoperative postbiotic (butyrate) given before colorectal cancer surgery
Official title: Randomized Clinical Trial on the Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery
Run by AC Camargo Cancer Center · NCT07268846 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 164 (estimated) |
| Sponsor | AC Camargo Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | June 1, 2027 |
| Study ends | June 1, 2027 |
| Registry record updated | December 8, 2025 |
| Trial ID | NCT07268846 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.