Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery

Официальное название

Postbiotics for Mitigation of Postoperative Dysbiosis in Gastrointestinal Cancer Surgery: A Randomized, Single-blinded, Placebo-controlled Trial (REPOT)

Обзор

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

Подробное описание

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.

Вмешательства

• Пищевая добавка PoZibio
  1 gummy once daily
• Пищевая добавка Inert placebo
  1 gummy once daily

Первичные конечные точки

• Change in fecal Shannon Diversity Index (SDI) [Срок оценки: Baseline, 2 weeks after surgery]

Вторичные конечные точки (12)

• Change in fecal SDI [Срок оценки: Baseline, 3 months after surgery]
• Change in fecal SDI [Срок оценки: Baseline, 12 months after surgery]
• Change in fecal SDI [Срок оценки: 1 week before surgery, 2 weeks after surgery]
• Change in fecal SDI [Срок оценки: 1 week before surgery, 3 months after surgery]
• Change in fecal SDI [Срок оценки: 1 week before surgery, 12 months after surgery]
• Change in pathogenic overgrowth in fecal microbiota [Срок оценки: Baseline, 2 weeks after surgery]
• Change in pathogenic overgrowth in fecal microbiota [Срок оценки: 3 months after surgery]
• Change in pathogenic overgrowth in fecal microbiota [Срок оценки: 12 months after surgery.]
• Digestion-associated quality of life questionnaire (DQLQ) scores [Срок оценки: Baseline]
• DQLQ scores [Срок оценки: 1 week before surgery]
• DQLQ scores [Срок оценки: 2 weeks after surgery]
• DQLQ scores [Срок оценки: 3 months after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Tampa General Hospital — Tampa
• University of South Florida — Tampa

Публикации

• 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 32054256
• 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 38323453
• 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 31586566
• 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 25250176
• 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 35732882
• 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 35366466
• 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 28753429
• 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 33579260

Идентификаторы

NCT: NCT07050485 · REPOT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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