Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery

Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery: A Randomized, Single-blinded, Placebo-controlled Trial (REPOT)

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.

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)