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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
1 gummy once daily
1 gummy once daily
Tampa General Hospital
Tampa, Florida, United States
University of South Florida
Tampa, Florida, United States
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
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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