By InvitationNot Applicable

Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery

United States30 participantsStarted 2025-07-15

Plain-language 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

Who can participate

Age range18 Years

SexALL

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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
✕. Prisoners
✕. Known allergy or intolerance to ingredients commonly used in gummy supplements (e.g., gelatin, corn syrup, artificial colors, or natural flavors)

What they're measuring

Change in fecal Shannon Diversity Index (SDI)

Timeframe: Baseline, 2 weeks after surgery

Trial details

NCT IDNCT07050485

SponsorUniversity of South Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-30

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