Postbiotics for Mitigation of Postoperative Dysbiosis in Colon Cancer Surgery

Not Applicable

Not yet recruiting

• Conditions: Colon Cancer

• Registration Number: NCT07050485
• Lead Sponsor: University of South Florida

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 Timeline

• Study First Submitted: 2025-06-20
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Study Start: 2025-07-15
• Primary Completion: 2026-04-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Recently diagnosed with nonmetastatic colon cancer, not treated with neoadjuvant therapy, and scheduled for an elective laparoscopic curative-intent colon cancer resection in ≥ 10 days
2. Able and willing to provide informed consent
3. Age 18 years and above

Exclusion Criteria

1. Currently taking prebiotic, probiotic, or postbiotic supplements
2. Exposed to antibiotics in the 3 months prior to enrollment (per patient-provided history)
3. Unlikely to comply with protocol as determined by Investigator
4. With ileostomies, as these will preclude colonic stool sampling
5. Prior use of any investigational drug in the preceding 6 months prior to enrollment
6. Patients with inflammatory bowel disease
7. Inability to give consent due to a mental condition that makes the participant unable to understand the study's nature, scope, and possible consequences.
8. Emergency surgery
9. Prisoners
10. Known allergy or intolerance to ingredients commonly used in gummy supplements (e.g., gelatin, corn syrup, artificial colors, or natural flavors)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in fecal SDI	1 week before surgery, 12 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
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 pathogenic overgrowth in fecal microbiota	12 months 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
DQLQ scores	12 months 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. This is compared between groups.
Change in DQLQ scores	12 months 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.

Trial Locations

Locations (2)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

University of South Florida; 🇺🇸 Tampa, Florida, United States