Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery: A Randomized, Single-blinded, Placebo-controlled Trial (REPOT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of South Florida
- Enrollment
- 30
- Locations
- 4
- Primary Endpoint
- Change in fecal Shannon Diversity Index (SDI)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Recently diagnosed with nonmetastatic GI cancer, including but not limited to small bowel, colon, rectal, pancreatic, gastric, or hepatic malignancies, and scheduled for an elective laparoscopic curative-intent surgical resection in 6 days
- •Able and willing to provide informed consent
- •Age 18 years and above
Exclusion Criteria
- •Exposed to antibiotics in the 3 months prior to enrollment (per patient-provided history)
- •Unlikely to comply with protocol as determined by Investigator
- •Prior use of any investigational drug in the preceding 6 months prior to enrollment
- •Patients with inflammatory bowel disease
- •Inability to give consent due to a mental condition that makes the participant unable to understand the study's nature, scope, and possible consequences.
- •Emergency surgery
- •Known allergy or intolerance to ingredients commonly used in gummy supplements (e.g., gelatin, corn syrup, artificial colors, or natural flavors)
Arms & Interventions
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.
Intervention: PoZibio (Dietary Supplement)
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.
Intervention: Inert placebo (Dietary Supplement)
Outcomes
Primary Outcomes
Change in fecal Shannon Diversity Index (SDI)
Time Frame: Baseline, 2 weeks after surgery
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
Secondary Outcomes
- Beta diversity of intratumoral microbiomes(Day 0)
- Change in fecal SDI(1 week before surgery, 12 months after surgery)
- Digestion-associated quality of life questionnaire (DQLQ) scores(Baseline)
- Change in pathogenic overgrowth in fecal microbiota(12 months after surgery.)
- DQLQ scores(12 months after surgery)
- Change in DQLQ scores(12 months after surgery)
- Change in fecal SDI(Baseline, 3 months after surgery)
- Change in fecal SDI(Baseline, 12 months after surgery)
- Change in fecal SDI(1 week before surgery, 2 weeks after surgery)
- Change in fecal SDI(1 week before surgery, 3 months after surgery)
- Change in pathogenic overgrowth in fecal microbiota(Baseline, 2 weeks after surgery)
- Change in pathogenic overgrowth in fecal microbiota(3 months after surgery)
- DQLQ scores(1 week before surgery)
- DQLQ scores(2 weeks after surgery)
- DQLQ scores(3 months after surgery)
- Change in DQLQ scores(Baseline, 2 weeks after surgery)
- Change in DQLQ scores(3 months after surgery)