Postbiotics for Mitigation of Postoperative Dysbiosis in Colon Cancer Surgery

University of South Florida

Status: Not yet enrolling

Conditions: Colon Cancer

Treatments: Dietary Supplement: PoZibio; Dietary Supplement: Inert placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07050485

REPOT

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Treatment Group

Active Comparator group

Description:

Treatment group will receive PoZibio at a dose of 1 gummy once daily for 7 days prior to surgery and 90 days post surgery. Pozibio will be administered as a chewable gummy formulation, to be taken orally at approximately the same time each day.

Treatment:

Dietary Supplement: PoZibio

Control Group

Placebo Comparator group

Description:

Control group will receive an inert placebo gummy, matched in appearance, taste, texture, and packaging to Pozibio®. The placebo will also be taken once daily for 7 days prior to surgery and 90 days post surgery, following the same schedule as the Test group.

Treatment:

Dietary Supplement: Inert placebo