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Enrolling by Invitation

NCT Number: NCT06634186

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannover Medical School (MHH)

Hanover, Lower Saxony, 30625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dietary intervention

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.

Primary outcomes

  1. Change of the Liver Frailty Index

    Time frame: The Liver Frailty Index will be measured at each study visit (Baseline, after 2 month and after 5 month)

Secondary outcomes

  1. Change of phase angle (°)

    Time frame: Phase angle will be measured at each study visit (Baseline, after 2 month and after 5 month)

    The phase angle will be measured with body impedance analysis (BIA).

  2. Change of systemic inflammation

    Time frame: Interleukin-6 will be measured at each study visit (Baseline, after 2 month and after 5 month)

    Measurement of interleukin-6

  3. Change of microbiome composition

    Time frame: Stool samples will be collected at each study visit (Baseline, after 2 month and after 5 month)

  4. Change of diet composition

    Time frame: Questionnaires will be collected at each study visit (Baseline, after 2 month and after 5 month)

    assessed with food-frequency-questionnaire (FFQ)

  5. Change of body cell mass (BCM; kg)

    Time frame: BCM will be measured at each study visit (Baseline, after 2 month and after 5 month)

    Body cell mass will be measured with body impedance analysis (BIA)

  6. Improvement of quality of life

    Time frame: Each study visit (Baseline, after 2 month and after 5 month)

    assessed with SF-36 questionnaire

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

The Impact of a Dietary Fiber Enriched Diet on Frailty, Sarcopenia, Systemic Inflammation and Microbiome Composition in Patients with Liver Cirrhosis

Acronym: ChainCirr

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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