Faecal Microbiota Transplantation for Liver Cirrhosis
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Faecal microbiota transplantation, Placebo.
- Кому может быть актуально
- Состояния в реестре: Liver Cirrhosis. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Дания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Faecal Microbiota Transplantation to Prevent Complications, Progression and Mortality of Liver Cirrhosis
Обзор
The purpose is to investigate the effect of faecal microbiota transplantation (FMT) on complications, progression, and mortality of patients with liver cirrhosis. Further, the investigators want to examine the impact of FMT on the gut microbiota, gut barrier function, systemic inflammation, and immune function.
Подробное описание
Patients with liver disease have a disturbed gut microbiota. This is often associated with disease progression and development of complications, so-called episodes of decompensation. In this trial, we will change the microbiota of these patients by transferring a healthy microbiota through faeces from a healthy donor, a procedure known as faecal microbiota transplantation (FMT). We will examine the effect of FMT on the prognosis and disease progression of the patients. Further, we will examine the mechanistic effects of FMT. We will at random divide 220 patients admitted with decompensation of liver cirrhosis evenly into two groups. One group will receive FMT and the other group will receive placebo. After the treatment, we will follow the patients for one year and examine disease progression as well as changes in their gut microbiota, gut barrier, and immune function.
Вмешательства
- Биопрепарат Faecal microbiota transplantation
All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year. - Биопрепарат Placebo
Placebo
Первичные конечные точки
- Time to death or new episode of acute decompensation requiring intervention in FMT versus placebo-treated patients. [Срок оценки: 1 year]
Вторичные конечные точки (12)
- Time to death or new episode of acute decompensation requiring intervention in FMT versus placebo-treated patients at 3 months and 6 months of follow-up. [Срок оценки: 3 months, 6 months]
- Number of new decompensations and deaths during follow-up in the FMT versus the placebo-treated patients. [Срок оценки: 1 year]
- Time to death in FMT versus placebo-treated patients. -treated patients at 3 months and 6 months of follow-up. [Срок оценки: 1 year, 6 months, 3 months]
- Change in gut microbiota beta-diversity (Bray-Curtis index) during one year in FMT versus placebo-treated patients by shotgun metagenomic sequencing. [Срок оценки: 1 year, 6 months, 3 months]
- Change in plasma concentration of gut translocation markers; lipopolysaccharide binding protein, soluble CD14, fatty acid binding protein 1 during one year in FMT versus placebo-treated patients by ELISA. [Срок оценки: 1 year, 6 months, 3 months]
- Change in plasma and stool concentration of pro- and antiinflammatory cytokines; IL-6, IL-1beta, TNF-alpha, IL-8, IL-10 in response to the intervention by luminex. [Срок оценки: 1 year, 6 months, 3 months]
- Change in disease severity in FMT- versus placebo-treated patients. [Срок оценки: 3 months, 6 months, 1 year.]
- Change in disease severity in FMT- versus placebo-treated patients. [Срок оценки: 3 months, 6 months, 1 year.]
- Change in disease severity in FMT- versus placebo-treated patients. [Срок оценки: 3 months, 6 months, 1 year.]
- Change in metabolic liver function in FMT- versus placebo-treated patients. [Срок оценки: 3 months, 6 months, 1 year.]
- Change in liver stiffness in FMT- versus placebo-treated patients. [Срок оценки: 3 months, 6 months, 1 year.]
- Change in the Liver Frailty Index in FMT- versus placebo-treated patients. [Срок оценки: 3 months, 6 months, 1 year.]
Критерии участия
Критерии включения
- Age 18-75 years
- Liver cirrhosis with Child-Pugh ≤ 12
- Acute decompensation requiring intervention (ascites, gastrointestinal bleeding, infections leading to progressive liver failure, overthepatic encephalopathy, alcoholic hepatitis)
Критерии исключения
- More than one organ failure defined by CLIF-SOFA score
- Untreated malignancy apart from non-melanoma skin cancer
- Untreated viral hepatitis
- HIV
- Inflammatory bowel disease
- Celiac disease
- Clostridioides Difficile infection
- Pregnancy
- Unable to participate based on medical judgement
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Дания · 1 центр
- Department of Hepatology and Gastroenterology, Aarhus University Hospital — Aarhus
Публикации
- Stoy S, Eriksen LL, Lauszus JS, Damsholt S, Baunwall SMD, Erikstrup C, Vilstrup H, Jepsen P, Hvas C, Thomsen KL. Cirrhosis and Faecal microbiota Transplantation (ChiFT) protocol: a Danish multicentre, randomised, placebo-controlled trial in patients with decompensated liver cirrhosis. BMJ Open. 2025 Feb 12;15(2):e091078. doi: 10.1136/bmjopen-2024-091078. PMID 39938959
Идентификаторы
NCT: NCT04932577 · 1-10-72-302-20