Colon Cancer, Gastrointestinal Cancer
Conditions
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.
Interventions
DIETARY_SUPPLEMENTPoZibio
1 gummy once daily
DIETARY_SUPPLEMENTInert placebo
1 gummy once daily
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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 2. Able and willing to provide informed consent 3. Age 18 years and above
Exclusion criteria
1. Exposed to antibiotics in the 3 months prior to enrollment (per patient-provided history) 2. Unlikely to comply with protocol as determined by Investigator 3. Prior use of any investigational drug in the preceding 6 months prior to enrollment 4. Patients with inflammatory bowel disease 5. Inability to give consent due to a mental condition that makes the participant unable to understand the study's nature, scope, and possible consequences. 6. Emergency surgery 7. Prisoners 8. Known allergy or intolerance to ingredients commonly used in gummy supplements (e.g., gelatin, corn syrup, artificial colors, or natural flavors)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fecal Shannon Diversity Index (SDI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Digestion-associated quality of life questionnaire (DQLQ) scores | Baseline | 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. |
| Change in fecal SDI | Baseline, 3 months 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 after surgery and baseline between two groups |
| DQLQ scores | 1 week before surgery | 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. |
| Change in DQLQ scores | Baseline, 2 weeks after surgery | 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. |
| Beta diversity of intratumoral microbiomes | Day 0 | Comparison of microbial community composition between groups. |
| Change in pathogenic overgrowth in fecal microbiota | Baseline, 2 weeks after surgery | 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 |
Countries
United States
Outcome results
None listed