Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT07050485
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PoZibio — DIETARY_SUPPLEMENT
    1 gummy once daily
  • Inert placebo — DIETARY_SUPPLEMENT
    1 gummy once daily

Study Details

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

Key Dates

Start date
Jul 15, 2025
Status verified
Dec 2025
Primary completion
Apr 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment Group
    Treatment group will receive PoZibio at a dose of 1 gummy once daily for 7 days prior to surgery and 90 days post surgery. Pozibio will be administered as a chewable gummy formulation, to be taken orally at approximately the same time each day.
  • Placebo Comparator: Control Group
    Control group will receive an inert placebo gummy, matched in appearance, taste, texture, and packaging to Pozibio®. The placebo will also be taken once daily for 7 days prior to surgery and 90 days post surgery, following the same schedule as the Test group.

Primary Outcome Measure

Change in fecal Shannon Diversity Index (SDI) [ Time Frame: Baseline, 2 weeks after surgery ]

Locations (2)

FacilityCityStateZIPSite coordinators
Tampa General HospitalTampaFlorida33606-
University of South FloridaTampaFlorida33606-

Find similar trials in Tampa, FL

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Tampa General Hospital· Tampa, FLUniversity of South Florida· Tampa, FL

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