The Impact of a Dietary Fiber Enriched Diet on the Outcome of Patients with Liver Cirrhosis

NCT ID: NCT06634186

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-23
• Study Completion Date: 2024-12-31

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.

Conditions

Liver Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Dietary intervention

The studied patients will receive a dietary intervention. This intervention includes a dietary counselling, that enables our patients to establish a fiber-enriched diet. This adapted diet will be supplemented by the short-chain-fatty-acid propionate, that functions as fiber-surrogate.

Group Type: EXPERIMENTAL

Dietary intervention

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hannover Medical School (MHH)

Hanover, Lower Saxony, Germany

Countries

Germany

Other Identifiers

10928_BO_S_2023

Identifier Type: -

Identifier Source: org_study_id