Clinical trial NCT06634186: The Impact of a Dietary Fiber Enriched Diet on the Outcome of Patients with Liver Cirrhosis
Official title: The Impact of a Dietary Fiber Enriched Diet on Frailty, Sarcopenia, Systemic Inflammation and Microbiome Composition in Patients with Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Liver Cirrhosis
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients of legal age and with the ability to give informed consent
* Patients with liver cirrhosis and portal hypertension

Exclusion Criteria:

* Patients with transjugular intrahepatic portosystemic shunt (TIPS)
* significant immunosuppression
* malignant tumor
* underage

Primary outcomes:
measure: Change of the Liver Frailty Index
timeFrame: The Liver Frailty Index will be measured at each study visit (Baseline, after 2 month and after 5 month)
Secondary outcomes:
measure: Change of phase angle (°)
timeFrame: Phase angle will be measured at each study visit (Baseline, after 2 month and after 5 month)
measure: Change of systemic inflammation
timeFrame: Interleukin-6 will be measured at each study visit (Baseline, after 2 month and after 5 month)
measure: Change of microbiome composition
timeFrame: Stool samples will be collected at each study visit (Baseline, after 2 month and after 5 month)
measure: Change of diet composition
timeFrame: Questionnaires will be collected at each study visit (Baseline, after 2 month and after 5 month)
measure: Change of body cell mass (BCM; kg)
timeFrame: BCM will be measured at each study visit (Baseline, after 2 month and after 5 month)
measure: Improvement of quality of life
timeFrame: Each study visit (Baseline, after 2 month and after 5 month)
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School (MHH)
state: Lower Saxony
Study officials:
References: