The Impact of a Dietary Fiber Enriched Diet on the Outcome of Patients with 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: Dietary intervention.
- Кому может быть актуально
- Состояния в реестре: Liver Cirrhosis. Базовые параметры: от 18 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
- Германия
- 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
The Impact of a Dietary Fiber Enriched Diet on Frailty, Sarcopenia, Systemic Inflammation and Microbiome Composition in Patients with Liver Cirrhosis
Обзор
The goal of this dietary intervention is to study the impact of a dietary fiber enriched diet on the intestinal dysbiosis, systemic inflammation and cirrhosis-related complications in patients with liver cirrhosis. Therefore, our aim is to investigate the impact of a dietary fiber enriched diet on * frailty and sarcopenia * systemic inflammation * microbiome composition * quality of life and the composition of patients diet. Participants receive a dietary counselling and will be asked to increase their dietary fiber intake. As malnutrition is a common complication in cirrhosis and patients with advanced liver disease often show a disability to meet their daily food-requirements, the recommended intake of 30 gram dietary fibers per day is unlikely in this group of patients. Therefore, the fiber-enriched diet will be supplemented by the physiological short-chain-fatty-acid propionate, as a fiber-surrogate.
Подробное описание
The disease course of liver cirrhosis is associated with a progressing dysbiosis of the intestinal microbiome and systemic inflammation, that leads to the development of cirrhosis-associated immune dysfunction (CAID). In healthy individuals, the microbiome uses orally incorporated dietary fibers for the production of short-chain-fatty-acids (SCFA). One of these physiological short-chain-fatty acids is propionate. SCFA´s are essential for a maintained integrity of the intestinal barrier and promote anti-inflammatory effects. Due to a reduction of symbiotic gut bacteria and an elevated number of potentially pathogenic microbes in cirrhosis, diminished levels of SCFA can be observed in this group of patients. Consequently, the permeability of the gut barrier increases and a bacterial translocation results. This translocation is a main driver of systemic inflammation and is linked to a higher likelihood for infections, such as spontaneous bacterial peritonitis (SBP). Furthermore, systemic inflammation promotes the degradation of skeleton muscles (sarcopenia) and frailty. Both are associated with a poor prognosis in cirrhosis. However, the impact of an adapted diet, that intends to normalize the intestinal SCFA-levels, on the clinical outcome of patients with advanced liver disease, needs to be further evaluated.
Therefore, the included patients receive dietary counseling, supplemented with propionate, that functions as fiber-surrogate. The dietary-intervention will last for a period of two months.
Вмешательства
- Пищевая добавка Dietary intervention
The aim of the dietary intervention is the implementation of a fiber-enriched diet. Therefore, patients receive dietary counseling, supplemented with propionate, that functions as fiber-surrogate.
Первичные конечные точки
- Change of the Liver Frailty Index [Срок оценки: The Liver Frailty Index will be measured at each study visit (Baseline, after 2 month and after 5 month)]
Вторичные конечные точки (6)
- Change of phase angle (°) [Срок оценки: Phase angle will be measured at each study visit (Baseline, after 2 month and after 5 month)]
- Change of systemic inflammation [Срок оценки: Interleukin-6 will be measured at each study visit (Baseline, after 2 month and after 5 month)]
- Change of microbiome composition [Срок оценки: Stool samples will be collected at each study visit (Baseline, after 2 month and after 5 month)]
- Change of diet composition [Срок оценки: Questionnaires will be collected at each study visit (Baseline, after 2 month and after 5 month)]
- Change of body cell mass (BCM; kg) [Срок оценки: BCM will be measured at each study visit (Baseline, after 2 month and after 5 month)]
- Improvement of quality of life [Срок оценки: Each study visit (Baseline, after 2 month and after 5 month)]
Критерии участия
Критерии включения
- Patients of legal age and with the ability to give informed consent
- Patients with liver cirrhosis and portal hypertension
Критерии исключения
- Patients with transjugular intrahepatic portosystemic shunt (TIPS)
- significant immunosuppression
- malignant tumor
- underage
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
- Поддерживающая терапия
Центры проведения
Германия · 1 центр
- Hannover Medical School (MHH) — Hanover
Идентификаторы
NCT: NCT06634186 · 10928_BO_S_2023