Viewing Study NCT06634186



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06634186
Status: ENROLLING_BY_INVITATION
Last Update Posted: None
First Post: 2024-07-18

Brief Title: The Impact of a Dietary Fiber Enriched Diet on the Outcome of Patients with Liver Cirrhosis
Sponsor: None
Organization: None

Study Overview

Official Title: The Impact of a Dietary Fiber Enriched Diet on Frailty Sarcopenia Systemic Inflammation and Microbiome Composition in Patients with Liver Cirrhosis
Status: ENROLLING_BY_INVITATION
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ChainCirr
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 SCFAs 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None