Fecal Microbiota Transplantation for Liver Failure

Официальное название

The Clinical Efficacy and Safety of Fecal Microbiota Transplantation in Patients With Acute-on-chronic Liver Failure

Обзор

To investigate the safety, adverse reactions and therapeutic effects of fecal microbiota transplantation on patients with liver failure;to investigate the effect of fecal microbiota transplantation on the intestinal microecology and "gut-liver axis immune system" of liver failure, and further optimization of fecal microbiota transplantation technology.

Вмешательства

• Другое fecal microbiota transplantation
  The fecal bacteria were transplanted once every 5 days for a total of 4 times

Первичные конечные точки

• Liver function change [Срок оценки: Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively]
• Coagulation function change [Срок оценки: Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively]
• Model for end-stage liver disease score change [Срок оценки: Model for end-stage liver disease score were obtained separately in 1 week before faecal bacteria transplantation, and to access once again at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively]
• gut microbiota change [Срок оценки: Fecal samples were collected 1 week before faecal bacteria transplantation, and change from at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively]
• Observe the clinical manifestations, safety and adverse reactions of the patients [Срок оценки: These indicators were collected 1 week before faecal bacteria transplantation, and change from at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively]
• proinflammatory cytokine change [Срок оценки: Blood samples were collected 1 week before faecal bacteria transplantation, and followed up at 5 day, 10 day, 15 day, 20 day, 4 and 8 weeks after faecal bacteria transplantation, respectively]

Критерии участия

Критерии включения

• Patients willing to sign informed consent
• Patients aged 18-65
• According to the diagnosis standard of liver failure in the guide for diagnosis and treatment of liver failure (2018 Edition), the eligible patients are included, that is, on the basis of chronic liver disease, the syndrome with acute jaundice deepening and coagulation dysfunction as the manifestation of liver failure caused by various inducements can be combined with complications such as Hepatoencephalopathy, ascites, electrolyte disorder, infection, hepatorenal syndrome, hepatopulmonary syndrome, etc And extrahepatic organ failure. The patient's jaundice deepened rapidly, the serum TBIL ≥ 10 × ULN or the daily rise ≥ 17.1 μ mol / L; there was bleeding, PTA ≤ 40% (or INR ≥ 1.5)

Критерии исключения

• Patients with severe heart failure, COPD, cerebrovascular accident, nephrotic syndrome, etc;
• Patients with gastrointestinal bleeding, pulmonary infection, septicemia, etc
• Patients with liver cancer, lung cancer, lymphoma and other malignant tumors
• Patients taking anticoagulants, mental diseases and immune diseases for a long time
• Pregnant or lactating women.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Ningbo Medical Center Lihuili Hospital,Affiliated Lihuili hospital of Ningbo University — Ningbo

Идентификаторы

NCT: NCT05170971 · KJ2019PJ021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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