NCT07050485

Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery

Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery: A Randomized, Single-blinded, Placebo-controlled Trial (REPOT)

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To measure the efficacy of postbiotic supplements in mitigating the gut dysbiosis induced by colon cancer surgery. Efficacy in mitigating dysbiosis will be measured by the change in fecal Shannon Diversity Index (SDI) within patients from the baseline sample to various postoperative timepoints. Mean change in SDI from baseline will be compared between groups at 2 weeks postoperative

Detailed description

This is a randomized, single-blinded study designed to assess the efficacy of postbiotic supplements in mitigating gut dysbiosis induced during the perioperative period of laparoscopic colon cancer surgery. Eligible participants, who are scheduled to undergo laparoscopic colon cancer surgery according to standard clinical procedures, will be enrolled following informed consent. Once consent is obtained, participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to either the Treatment group or the Control group. Both groups will take 1 gummy once daily ≥ 7 days prior to surgery and 90 days post surgery. Stool samples will be collected at five timepoints, along with a portion of the tumor tissue resected at surgery. The collected samples will be compared between the treatment and control groups.

Conditions

• Colon Cancer
• Gastrointestinal Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PoZibio	1 gummy once daily
DIETARY_SUPPLEMENT	Inert placebo	1 gummy once daily

Timeline

• Start date: 2025-07-15
• Primary completion: 2026-04-30
• Completion: 2026-12-30
• First posted: 2025-07-03
• Last updated: 2025-12-29

Locations

2 sites across 1 country: United States