Postbiotics for Mitigation of Postoperative Dysbiosis in Colon Cancer Surgery
Launched by UNIVERSITY OF SOUTH FLORIDA · Jul 2, 2025
Trial Information
Current as of July 24, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at whether taking postbiotic supplements—these are products made from helpful bacteria—can help balance the gut after surgery for colon cancer. Surgery can sometimes disrupt the natural mix of bacteria in the gut, which may affect recovery. The study will check if these supplements improve gut health by measuring changes in the variety of bacteria found in stool samples before and after surgery.
People who might join this study are adults diagnosed with colon cancer that has not spread, who are planning to have planned (not emergency) laparoscopic surgery to remove the cancer. To be eligible, participants should not have taken antibiotics recently or be using other similar supplements like probiotics or prebiotics. Those interested will provide stool samples before and after surgery to see how their gut bacteria change, and they will take the postbiotic supplements during this time. The study is not yet recruiting participants but aims to better understand how to support gut health after colon cancer surgery.
Gender
ALL
Eligibility criteria
- 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)
About University Of South Florida
The University of South Florida (USF) is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a strong commitment to improving patient outcomes, USF leverages its diverse faculty expertise and state-of-the-art facilities to conduct rigorous and ethically sound research. The university fosters collaboration across disciplines, engaging in partnerships that enhance the translation of scientific discoveries into effective therapeutic interventions. USF's clinical trial programs are designed to address pressing health challenges and contribute to the body of knowledge in various medical fields, ultimately aiming to benefit communities and improve public health.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tampa, Florida, United States
Tampa, Florida, United States
Patients applied
Trial Officials
Richard Jacobson, MD
Principal Investigator
University of South Florida
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported