Clinical trial · Interventional
Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery
Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery: A Randomized, Single-blinded, Placebo-controlled Trial (REPOT)
NCT07050485CI-TRIAL-00099779enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Gastrointestinal Cancer | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inert placebo | Dietary Supplement | — | UNRESOLVED |
| PoZibio | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment 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.
- interventionNames
- Dietary Supplement: PoZibio
- type
- PLACEBO_COMPARATOR
- label
- Control 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.
- interventionNames
- Dietary Supplement: Inert placebo
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (12)
- BACKGROUNDOh 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 32054256
- RESULTNors 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 38323453
- RESULTSong 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 31586566
- RESULTShogan 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 25250176
- RESULTNalluri-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 35732882
- RESULTWilliamson 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 35366466
- RESULTYu 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.