An interventional study of PoZibio and Inert placebo in Colon Cancer and Gastrointestinal Cancer, sponsored by University of South Florida. Enrolling by invitation at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by University of South Florida · Not applicable, Interventional, and Treatment
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
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's planned enrollment of 30 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Dietary Supplement: PoZibio
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.
Dietary Supplement: Inert placebo
1 gummy once daily
1 gummy once daily
Change in fecal Shannon Diversity Index (SDI)
The SDI is a number that reflects both the variety and balance of bacteria in the sample. A higher number means a more diverse bacterial community. Change in fecal SDI is difference at 2 weeks after surgery and baseline between two groups
Time frame: Baseline, 2 weeks after surgery
Change in fecal SDI
The SDI is a number that reflects both the variety and balance of bacteria in the sample. A higher number means a more diverse bacterial community. Change in fecal SDI is difference at after surgery and baseline between two groups
Time frame: Baseline, 3 months after surgery
Change in fecal SDI
The SDI is a number that reflects both the variety and balance of bacteria in the sample. A higher number means a more diverse bacterial community. Change in fecal SDI is difference at after surgery and baseline between two groups
Time frame: Baseline, 12 months after surgery
Change in fecal SDI
The SDI is a number that reflects both the variety and balance of bacteria in the sample. A higher number means a more diverse bacterial community. Change in fecal SDI is difference at after surgery and baseline between two groups
Time frame: 1 week before surgery, 2 weeks after surgery
Change in fecal SDI
The SDI is a number that reflects both the variety and balance of bacteria in the sample. A higher number means a more diverse bacterial community. Change in fecal SDI is difference at after surgery and baseline between two groups
Time frame: 1 week before surgery, 3 months after surgery
Change in fecal SDI
The SDI is a number that reflects both the variety and balance of bacteria in the sample. A higher number means a more diverse bacterial community. Change in fecal SDI is difference at after surgery and baseline between two groups
Time frame: 1 week before surgery, 12 months after surgery
Change in pathogenic overgrowth in fecal microbiota
The relative mean abundance of specific potential pathogenic bacterial species will be measured in fecal samples. An increase in relative abundance may indicate potential overgrowth. Change in pathogenic overgrowth is difference between after surgery and baseline between groups
Time frame: Baseline, 2 weeks after surgery
Change in pathogenic overgrowth in fecal microbiota
The relative mean abundance of specific potential pathogenic bacterial species will be measured in fecal samples. An increase in relative abundance may indicate potential overgrowth. Change in pathogenic overgrowth is difference between after surgery and baseline between groups
Time frame: 3 months after surgery
Change in pathogenic overgrowth in fecal microbiota
The relative mean abundance of specific potential pathogenic bacterial species will be measured in fecal samples. An increase in relative abundance may indicate potential overgrowth. Change in pathogenic overgrowth is difference between after surgery and baseline between groups
Time frame: 12 months after surgery.
Digestion-associated quality of life questionnaire (DQLQ) scores
DQLQ includes 9 statements that assess how often digestive events and experiences affected the physical and mental aspects of quality of life over the past 7 days. The score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life. This is compared between groups.
Time frame: Baseline
DQLQ scores
DQLQ includes 9 statements that assess how often digestive events and experiences affected the physical and mental aspects of quality of life over the past 7 days. The score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life. This is compared between groups.
Time frame: 1 week before surgery
DQLQ scores
DQLQ includes 9 statements that assess how often digestive events and experiences affected the physical and mental aspects of quality of life over the past 7 days. The score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life. This is compared between groups.
Time frame: 2 weeks after surgery
DQLQ scores
DQLQ includes 9 statements that assess how often digestive events and experiences affected the physical and mental aspects of quality of life over the past 7 days. The score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life. This is compared between groups.
Time frame: 3 months after surgery
DQLQ scores
DQLQ includes 9 statements that assess how often digestive events and experiences affected the physical and mental aspects of quality of life over the past 7 days. The score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life. This is compared between groups.
Time frame: 12 months after surgery
Change in DQLQ scores
DQLQ includes 9 statements that assess how often digestive events and experiences affected the physical and mental aspects of quality of life over the past 7 days. The score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life. Change in DQLQ score is difference between after surgery and before surgery between groups.
Time frame: Baseline, 2 weeks after surgery
Change in DQLQ scores
DQLQ includes 9 statements that assess how often digestive events and experiences affected the physical and mental aspects of quality of life over the past 7 days. The score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life. Change in DQLQ score is difference between after surgery and before surgery between groups.
Time frame: 3 months after surgery
Change in DQLQ scores
DQLQ includes 9 statements that assess how often digestive events and experiences affected the physical and mental aspects of quality of life over the past 7 days. The score ranges from 0-9. A higher score indicates a lower (worse) digestion-associated quality of life. Change in DQLQ score is difference between after surgery and before surgery between groups.
Time frame: 12 months after surgery
Beta diversity of intratumoral microbiomes
Comparison of microbial community composition between groups.
Time frame: Day 0
Plan to share: No
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