Liver CirrhosisChainCirrNCT06634186
The Impact of a Dietary Fiber Enriched Diet on the Outcome of Patients with Liver Cirrhosis
A study testing Dietary intervention in people with Liver Cirrhosis, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteGermany
- Study dates
- 23 Jan 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of legal age and with the ability to give informed consent
- Patients with liver cirrhosis and portal hypertension
Who cannot join
- Patients with transjugular intrahepatic portosystemic shunt (TIPS)
- significant immunosuppression
- malignant tumor
- underage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Dietary Fiber Enriched Diet on Frailty, Sarcopenia, Systemic Inflammation and Microbiome Composition in 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
Read more
- 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.
Read the 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
- Being tested
- Dietary intervention
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary interventionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | 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. Receives: Dietary Supplement: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Liver Frailty Index
Measured: The Liver Frailty Index will be measured at each study visit (Baseline, after 2 month and after 5 month)
Secondary outcomes (6)
Change of phase angle (°)
The phase angle will be measured with body impedance analysis (BIA).
Measured: Phase angle will be measured at each study visit (Baseline, after 2 month and after 5 month)
Change of systemic inflammation
Measurement of interleukin-6
Measured: Interleukin-6 will be measured at each study visit (Baseline, after 2 month and after 5 month)
Change of microbiome composition
Measured: Stool samples will be collected at each study visit (Baseline, after 2 month and after 5 month)
Change of diet composition
assessed with food-frequency-questionnaire (FFQ)
Measured: Questionnaires will be collected at each study visit (Baseline, after 2 month and after 5 month)
Change of body cell mass (BCM; kg)
Body cell mass will be measured with body impedance analysis (BIA)
Measured: BCM will be measured at each study visit (Baseline, after 2 month and after 5 month)
Improvement of quality of life
assessed with SF-36 questionnaire
Measured: Each study visit (Baseline, after 2 month and after 5 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start23 Jan 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634186
- Sponsor's protocol ID
- 10928_BO_S_2023
- Acronym
- ChainCirr
- Status last verified
- Oct 2024
- First submitted
- 18 Jul 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Dietary Fiber Enriched Diet on Frailty, Sarcopenia, Systemic Inflammation and Microbiome Composition in Patients with Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT06634186
- Acronym / sponsor ID
- ChainCirr / 10928_BO_S_2023
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Dietary Supplement: Dietary interventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of legal age and with the ability to give informed consent
- Patients with liver cirrhosis and portal hypertension
Key exclusion criteria (4 listed)
- Patients with transjugular intrahepatic portosystemic shunt (TIPS)
- significant immunosuppression
- malignant tumor
- underage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary interventionThe 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. | Dietary supplement | Dietary intervention |
Primary outcome
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)
6 secondary outcomes
Change of phase angle (°)
Time frame: Phase angle will be measured at each study visit (Baseline, after 2 month and after 5 month)
Change of systemic inflammation
Time frame: Interleukin-6 will be measured at each study visit (Baseline, after 2 month and after 5 month)
Change of microbiome composition
Time frame: Stool samples will be collected at each study visit (Baseline, after 2 month and after 5 month)
Change of diet composition
Time frame: Questionnaires will be collected at each study visit (Baseline, after 2 month and after 5 month)
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)
Improvement of quality of life
Time frame: Each study visit (Baseline, after 2 month and after 5 month)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary intervention in people with Liver Cirrhosis, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.