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Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery

NCT ID: NCT07050485

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-12-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Colon Cancer Gastrointestinal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Treatment Group

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.

Group Type ACTIVE_COMPARATOR

PoZibio

Intervention Type DIETARY_SUPPLEMENT

1 gummy once daily

Control Group

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.

Group Type PLACEBO_COMPARATOR

Inert placebo

Intervention Type DIETARY_SUPPLEMENT

1 gummy once daily

Interventions

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PoZibio

1 gummy once daily

Intervention Type DIETARY_SUPPLEMENT

Inert placebo

1 gummy once daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Jacobson, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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Tampa General Hospital

Tampa, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32054256 (View on PubMed)

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.

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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.

Reference Type RESULT
PMID: 31586566 (View on PubMed)

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.

Reference Type RESULT
PMID: 25250176 (View on PubMed)

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.

Reference Type RESULT
PMID: 35732882 (View on PubMed)

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.

Reference Type RESULT
PMID: 35366466 (View on PubMed)

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.

Reference Type RESULT
PMID: 28753429 (View on PubMed)

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.

Reference Type RESULT
PMID: 33579260 (View on PubMed)

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.

Reference Type RESULT
PMID: 18279948 (View on PubMed)

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.

Reference Type RESULT
PMID: 32819443 (View on PubMed)

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.

Reference Type RESULT
PMID: 33157233 (View on PubMed)

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.

Reference Type RESULT
PMID: 30139941 (View on PubMed)

Other Identifiers

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REPOT

Identifier Type: -

Identifier Source: org_study_id