Study on the Effect of Fecal Microbiota Transplantation on Eradication of Refractory Helicobacter Pylori Infection

Обзор

To determine whether regulating the gut microbiota can contribute to the eradication of refractory H. pylori infection.

Вмешательства

• Биопрепарат transanal fecal bacteria transplant
  Received transanal fecal bacteria transplant

Первичные конечные точки

• Whether Hp is successfully eradicated [Срок оценки: 2years]

Критерии участия

Критерии включения

• 1\. Ages 18-70
• 2\. Hp infection treatment failed ≥4 times with guidelines-recommended therapies
• 3\. Patients with early gastric cancer, peptic ulcer, gastric MALT lymphoma, atrophic gastritis and other diseases requiring the eradication of Hp.

Критерии исключения

• 1\. Antibiotics and bismuth were taken within 4 weeks before this treatment; Or had taken PPI, H2 receptor antagonist, P-CAB within 2 weeks prior to treatment;
• 2\. Pregnant or lactating women;
• 3\. Those who are allergic to the investigational drugs used in this test or have contraindications;
• 4\. Participated in other drug trials within 3 months before the treatment of this trial;
• 5\. There are other serious diseases that affect the evaluation of this study at the same time, or they cannot correctly express their own complaints and cannot cooperate;
• 6\. Subjects with dysphagia;
• 7\. Patients with malignant tumors, serious concomitant diseases, severe ulcer bleeding or perforation;
• 8\. Patients judged by the investigator to be unsuitable for clinical trials.
• 9\. Those who do not want to sign the informed consent for the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Sichuan Provincial People's Hospital — Чэнду

Публикации

• Chen YC, Malfertheiner P, Yu HT, Kuo CL, Chang YY, Meng FT, Wu YX, Hsiao JL, Chen MJ, Lin KP, Wu CY, Lin JT, O'Morain C, Megraud F, Lee WC, El-Omar EM, Wu MS, Liou JM. Global Prevalence of Helicobacter pylori Infection and Incidence of Gastric Cancer Between 1980 and 2022. Gastroenterology. 2024 Apr;166(4):605-619. doi: 10.1053/j.gastro.2023.12.022. Epub 2024 Jan 2. PMID 38176660
• Kuo CJ, Lee CH, Chang ML, Lin CY, Lin WR, Su MY, Chiu CH, Tseng CN, Wu YS, Chiu CT, Lai CH. Multidrug resistance: The clinical dilemma of refractory Helicobacter pylori infection. J Microbiol Immunol Infect. 2021 Dec;54(6):1184-1187. doi: 10.1016/j.jmii.2021.03.006. Epub 2021 Mar 23. PMID 33840604
• Choi IJ, Kook MC, Kim YI, Cho SJ, Lee JY, Kim CG, Park B, Nam BH. Helicobacter pylori Therapy for the Prevention of Metachronous Gastric Cancer. N Engl J Med. 2018 Mar 22;378(12):1085-1095. doi: 10.1056/NEJMoa1708423. PMID 29562147
• Su NY, Shi Q, Mei H, Hu J, Liu YX, Liu HN, Liu HQ, Guo Y, Wang XW, Lan CH. Efficacy and safety of vonoprazan-based dual therapy and esomeprazole-based dual therapy in eradicating primary Helicobacter pylori infection: A propensity score matching analysis. Helicobacter. 2023 Oct;28(5):e13003. doi: 10.1111/hel.13003. Epub 2023 Aug 10. PMID 37565458
• Shirai N, Sugimoto M, Kodaira C, Nishino M, Ikuma M, Kajimura M, Ohashi K, Ishizaki T, Hishida A, Furuta T. Dual therapy with high doses of rabeprazole and amoxicillin versus triple therapy with rabeprazole, amoxicillin, and metronidazole as a rescue regimen for Helicobacter pylori infection after the standard triple therapy. Eur J Clin Pharmacol. 2007 Aug;63(8):743-9. doi: 10.1007/s00228-007-0302 PMID 17565490
• Liu D, Wang J, Xie Y. Refractory Helicobacter pylori infection and the gastric microbiota. Front Cell Infect Microbiol. 2022 Sep 27;12:976710. doi: 10.3389/fcimb.2022.976710. eCollection 2022. PMID 36237432
• Shirzad-Aski H, Besharat S, Kienesberger S, Sohrabi A, Roshandel G, Amiriani T, Norouzi A, Keshtkar A. Association Between Helicobacter pylori Colonization and Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis. J Clin Gastroenterol. 2021 May-Jun 01;55(5):380-392. doi: 10.1097/MCG.0000000000001415. PMID 32833699
• Tepler A, Narula N, Peek RM Jr, Patel A, Edelson C, Colombel JF, Shah SC. Systematic review with meta-analysis: association between Helicobacter pylori CagA seropositivity and odds of inflammatory bowel disease. Aliment Pharmacol Ther. 2019 Jul;50(2):121-131. doi: 10.1111/apt.15306. Epub 2019 Jun 5. PMID 31165513

Идентификаторы

NCT: NCT07704255 · 20240507

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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