NCT07050485

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jul 2025

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

June 20, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

December 29, 2025

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

June 20, 2025

Last Update Submit

December 19, 2025

Conditions

Colon CancerGastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

  • Change in fecal Shannon Diversity Index (SDI)

    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

    Baseline, 2 weeks after surgery

Secondary Outcomes (17)

  • Change in fecal SDI

    Baseline, 3 months after surgery

  • Change in fecal SDI

    Baseline, 12 months after surgery

  • Change in fecal SDI

    1 week before surgery, 2 weeks after surgery

  • Change in fecal SDI

    1 week before surgery, 3 months after surgery

  • Change in fecal SDI

    1 week before surgery, 12 months after surgery

  • +12 more secondary outcomes

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

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.

Dietary Supplement: PoZibio

Control Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Inert placebo

Interventions

PoZibioDIETARY_SUPPLEMENT

1 gummy once daily

Treatment Group
Inert placeboDIETARY_SUPPLEMENT

1 gummy once daily

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Related Publications (12)

  • Oh CK, Huh JW, Lee YJ, Choi MS, Pyo DH, Lee SC, Park SM, Shin JK, Park YA, Cho YB, Yun SH, Kim HC, Lee WY. Long-term Oncologic Outcome of Postoperative Complications After Colorectal Cancer Surgery. Ann Coloproctol. 2020 Aug;36(4):273-280. doi: 10.3393/ac.2019.10.15. Epub 2019 Nov 13.

    PMID: 32054256BACKGROUND

  • Nors J, Gotschalck KA, Erichsen R, Andersen CL. Incidence of late recurrence and second primary cancers 5-10 years after non-metastatic colorectal cancer. Int J Cancer. 2024 Jun 1;154(11):1890-1899. doi: 10.1002/ijc.34871. Epub 2024 Feb 7.

    PMID: 38323453RESULT

  • Song M, Chan AT, Sun J. Influence of the Gut Microbiome, Diet, and Environment on Risk of Colorectal Cancer. Gastroenterology. 2020 Jan;158(2):322-340. doi: 10.1053/j.gastro.2019.06.048. Epub 2019 Oct 3.

    PMID: 31586566RESULT

  • Shogan BD, Smith DP, Christley S, Gilbert JA, Zaborina O, Alverdy JC. Intestinal anastomotic injury alters spatially defined microbiome composition and function. Microbiome. 2014 Sep 15;2:35. doi: 10.1186/2049-2618-2-35. eCollection 2014.

    PMID: 25250176RESULT

  • Nalluri-Butz H, Bobel MC, Nugent J, Boatman S, Emanuelson R, Melton-Meaux G, Madoff RD, Jahansouz C, Staley C, Gaertner WB. A pilot study demonstrating the impact of surgical bowel preparation on intestinal microbiota composition following colon and rectal surgery. Sci Rep. 2022 Jun 22;12(1):10559. doi: 10.1038/s41598-022-14819-1.

    PMID: 35732882RESULT

  • Williamson AJ, Jacobson R, van Praagh JB, Gaines S, Koo HY, Lee B, Chan WC, Weichselbaum R, Alverdy JC, Zaborina O, Shogan BD. Enterococcus faecalis promotes a migratory and invasive phenotype in colon cancer cells. Neoplasia. 2022 May;27:100787. doi: 10.1016/j.neo.2022.100787. Epub 2022 Mar 30.

    PMID: 35366466RESULT

  • Yu T, Guo F, Yu Y, Sun T, Ma D, Han J, Qian Y, Kryczek I, Sun D, Nagarsheth N, Chen Y, Chen H, Hong J, Zou W, Fang JY. Fusobacterium nucleatum Promotes Chemoresistance to Colorectal Cancer by Modulating Autophagy. Cell. 2017 Jul 27;170(3):548-563.e16. doi: 10.1016/j.cell.2017.07.008.

    PMID: 28753429RESULT

  • Agnes A, Puccioni C, D'Ugo D, Gasbarrini A, Biondi A, Persiani R. The gut microbiota and colorectal surgery outcomes: facts or hype? A narrative review. BMC Surg. 2021 Feb 12;21(1):83. doi: 10.1186/s12893-021-01087-5.

    PMID: 33579260RESULT

  • Besselink MG, van Santvoort HC, Buskens E, Boermeester MA, van Goor H, Timmerman HM, Nieuwenhuijs VB, Bollen TL, van Ramshorst B, Witteman BJ, Rosman C, Ploeg RJ, Brink MA, Schaapherder AF, Dejong CH, Wahab PJ, van Laarhoven CJ, van der Harst E, van Eijck CH, Cuesta MA, Akkermans LM, Gooszen HG; Dutch Acute Pancreatitis Study Group. Probiotic prophylaxis in predicted severe acute pancreatitis: a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Feb 23;371(9613):651-659. doi: 10.1016/S0140-6736(08)60207-X. Epub 2008 Feb 14.

    PMID: 18279948RESULT

  • Nataraj BH, Ali SA, Behare PV, Yadav H. Postbiotics-parabiotics: the new horizons in microbial biotherapy and functional foods. Microb Cell Fact. 2020 Aug 20;19(1):168. doi: 10.1186/s12934-020-01426-w.

    PMID: 32819443RESULT

  • D'Auria E, Panelli S, Lunardon L, Pajoro M, Paradiso L, Beretta S, Loretelli C, Tosi D, Perini M, Bedogni G, Abdelsalam A, Fiorina P, Bandi C, Zuccotti GV. Rice flour fermented with Lactobacillus paracasei CBA L74 in the treatment of atopic dermatitis in infants: A randomized, double- blind, placebo- controlled trial. Pharmacol Res. 2021 Jan;163:105284. doi: 10.1016/j.phrs.2020.105284. Epub 2020 Nov 4.

    PMID: 33157233RESULT

  • Nagpal R, Wang S, Ahmadi S, Hayes J, Gagliano J, Subashchandrabose S, Kitzman DW, Becton T, Read R, Yadav H. Human-origin probiotic cocktail increases short-chain fatty acid production via modulation of mice and human gut microbiome. Sci Rep. 2018 Aug 23;8(1):12649. doi: 10.1038/s41598-018-30114-4.

    PMID: 30139941RESULT

MeSH Terms

Conditions

Colonic NeoplasmsGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Richard Jacobson, MD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2025

First Posted

July 3, 2025

Study Start

July 15, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

December 29, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)