Hepatic EncephalopathyNCT06040814
Microbiota, Sarcopenia, and Hepatic Encephalopathy Change in Cirrhotic Patients Before and After Rehabilitation
A study testing Rehabilitation Training in people with Hepatic Encephalopathy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Through this plan, it will provide many benefits to patients with liver cirrhosis complicated with sarcopenia and/or hepatic encephalopathy, their family members, and the government in Taiwan: 1. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hepatic Encephalopathy
- What is being tested?
- Rehabilitation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2022to 30 Nov 2025
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with liver cirrhosis
Who cannot join
- unstable vital sign such as shock, coma or intubation status
- Non-curative hepatocellular carcinoma (cannot receive operation, radiofrequency ablation, liver transplantation,etc
- Un-curative malignancies
- Poor-controlled diabetes mellitus (HbA1C≧8)
- Active alcoholism (male alcohol ≧40g/day, or ≧140g/week; female ≧ 30g/day, or ≧70g/week
- Psychiatric comorbidities
Show all 10Show fewer
- Neurologic comorbidities like Alzheimer's, Parkinson's, stroke with neurological deficit
- Unable to speak
- Bed-ridden status
- Post- Liver transplantation.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
CHIEN-HUNG CHEN, MD, +886 9753 66128, q12248@cgmh.org.tw
About this study
Official title: To Explore the Changes of Fecal Microbiota Before and After Treatment in Patients With Liver Cirrhosis Complicated With Hepatic Encephalopathy or Sarcopenia as a Reference for Future Fecal Microbiota Transplantation
Through this plan, it will provide many benefits to patients with liver cirrhosis complicated with sarcopenia and/or hepatic encephalopathy, their family members, and the government in Taiwan:
- To explore the changes of fecal microbiota before and after treatment such as resistance training rehabilitation in patients with liver cirrhosis complicated with sarcopenia and/or hepatic encephalopathy as a reference for future fecal microbiota transplantation;
- To measure the changes of sarcopenia level before and after rehabilitation;
- To measure the changes of hepatic encephalopathy level before and after rehabilitation.
These study results will certainly bring updated diagnostic tool, latest treatment options, avoid serious sequelae and reduce medical expenditure.
Read the detailed description
Chronic liver disease is notorious as Taiwan's national disease and more than 4,000 patients died of liver cirrhosis each year in Taiwan. Hepatic encephalopathy (HE) manifests from minimal HE (MHE) to overt HE (OHE). The diagnosis of covert HE (CHE) requires psychometric tests or neurophysiological tools. However, psychometric testing for patients with CHE is often neglected in Taiwan. On the basis of the capability to detect all forms of HE, further investigation on the association of HE with fecal microbiota alterations is urgently needed. It is because HE is associated with dysregulation in the gut-liver-brain axis, which includes intestinal barrier dysfunction and gut microbial dysbiosis. However, despite current standard of care (SOC) therapy i.e., lactulose and rifaximin, there remains a subset of patients who continue to suffer recurrence, which leads to further cognitive impairment, sarcopenia and readmissions. There remain several factors that can influence the microbiota, such as demographics (geographic area, sex and diet), etiology, drugs, interventions, and finally the sampling compartment. These factors need to be controlled for and considered in the interpretation of future studies. The microbiome dynamic change during rehabilitation in cirrhotic patients with sarcopenia has never been studied and is worth exploring.
Furthermore, from our previous study, the investigators have shown that one-year efficacy of rifaximin add-on to lactulose is superior to lactulose alone in patients with cirrhosis complicated with recurrent HE in Taiwan. The investigators also have preliminary data showing that rehabilitation could improve patient's sarcopenia. Further cohort validation is urgently required.
Our innovative research purposes:
- To explore the changes of fecal microbiota before and after treatment such as resistance training rehabilitation as a reference for future fecal microbiota transplantation;
- To measure the changes of sarcopenia levels before and after rehabilitation
- Conditions
- Hepatic Encephalopathy
- Being tested
- Rehabilitation Training
- Keywords
- Liver cirrhosis, Hepatic encephalopathy, Psychometric test, Sarcopenia, Fecal microbiota
- Medical subject headings
- Hepatic Encephalopathy, Liver Cirrhosis, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation TrainingBehavioural
12 week Rehabilitation Training course
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Training | Experimental | Rehabilitation Training is provided to patients with Liver Cirrhosis combined with sarcopenia. Receives: Behavioral: Rehabilitation Training |
| No-Rehabilitation Training | No intervention | No extra training is provided to patients with Liver Cirrhosis combined with sarcopenia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handgrip Strength
Handgrip strength is an assessment of muscle strength. The cutoff value of the handgrip is < 30 kg in men and < 20 kg in women.
Measured: 6 months
Short Physical Performance Battery (SPPB)
Short Physical Performance Battery (SPPB) is an assessment of physical performance. The cut-off value of the Short Physical Performance Battery (SPPB) score for determining sarcopenia is ≤ 9.
Measured: 6 months
Dual-energy X-ray absorptiometry (DEXA)
Dual-energy X-ray absorptiometry (DXA) is the gold-standard technique in the analysis of body composition. The cut-off value of appendicular skeletal muscle mass (ASMI) score for determining sarcopenia is < 7.0 kg/m^2 in men and < 5.4 kg/m^2 in women.
Measured: 6 months
Mini-Mental Status Examination (MMSE)
Mini-Mental State Examination (MMSE) is one of the most commonly used methods in the assessment of cognitive mental status. The cut-off value of Mini-Mental State Examination (MMSE) score is < 28.
Measured: 6 months
Psychometric Hepatic Encephalopathy Score (PHES)
The psychometric hepatic encephalopathy score (PHES) is the gold standard for diagnosing minimal hepatic encephalopathy (MHE). The cut-off value of the Psychometric Hepatic Encephalopathy Score (PHES) for determining minimal hepatic encephalopathy (MHE) is ≤ -4.
Measured: 6 months
Animal Naming Test (ANT)
The animal naming test (ANT) is an easy tool for the assessment of hepatic encephalopathy (HE). The cut-off value of the Animal Naming Test (ANT) score for determining hepatic encephalopathy (HE) is ≤ 19.
Measured: 6 months
Blood cytokine levels [IL-6]
Serum IL-6 level (pg/ mL)
Measured: 6 months
Blood ammonia levels [NH3]
Serum ammonia level (μg/dL)
Measured: 6 months
Electroencephalogram (EEG)
Quantified EEG spectral analysis:
Grade 0: Mean dominant frequency (MDF)> 6.8 Hz and no theta nor delta wave Grade 1: MDF > 6.8Hz and theta wave relative power ≧35% Grade 2: MDF≤ 6.8 Hz and delta wave relative power<49% Grade 3: MDF≤ 6.8 Hz and delta wave relative power≧49%
Measured: 6 months
Fecal Microbiota
Check fecal microbiota taxonomy profile and relative abundance changes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start1 Dec 2022
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHIEN-HAO HUANG, Principal investigator, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040814
- Sponsor's protocol ID
- 202201561B0
- Status last verified
- Dec 2022
- First submitted
- 8 Aug 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Changes of Fecal Microbiota Before and After Treatment in Patients With Liver Cirrhosis Complicated With Hepatic Encephalopathy or Sarcopenia as a Reference for Future Fecal Microbiota Transplantation
- ClinicalTrials.gov ID
- NCT06040814
- Acronym / sponsor ID
- 202201561B0
- Conditions
- Hepatic Encephalopathy
- Keywords
- Liver cirrhosis, Hepatic encephalopathy, Psychometric test, Sarcopenia, Fecal microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 18 Sep 2023 (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.
Through this plan, it will provide many benefits to patients with liver cirrhosis complicated with sarcopenia and/or hepatic encephalopathy, their family members, and the government in Taiwan:
- To explore the changes of fecal microbiota before and after treatment such as resistance training rehabilitation in patients with liver cirrhosis complicated with sarcopenia and/or hepatic encephalopathy as a reference for future fecal microbiota transplantation;
- To measure the changes of sarcopenia level before and after rehabilitation;
- To measure the changes of hepatic encephalopathy level before and after rehabilitation.
These study results will certainly bring updated diagnostic tool, latest treatment options, avoid serious sequelae and reduce medical expenditure.
Detailed description
Chronic liver disease is notorious as Taiwan's national disease and more than 4,000 patients died of liver cirrhosis each year in Taiwan. Hepatic encephalopathy (HE) manifests from minimal HE (MHE) to overt HE (OHE). The diagnosis of covert HE (CHE) requires psychometric tests or neurophysiological tools. However, psychometric testing for patients with CHE is often neglected in Taiwan. On the basis of the capability to detect all forms of HE, further investigation on the association of HE with fecal microbiota alterations is urgently needed. It is because HE is associated with dysregulation in the gut-liver-brain axis, which includes intestinal barrier dysfunction and gut microbial dysbiosis. However, despite current standard of care (SOC) therapy i.e., lactulose and rifaximin, there remains a subset of patients who continue to suffer recurrence, which leads to further cognitive impairment, sarcopenia and readmissions. There remain several factors that can influence the microbiota, such as demographics (geographic area, sex and diet), etiology, drugs, interventions, and finally the sampling compartment. These factors need to be controlled for and considered in the interpretation of future studies. The microbiome dynamic change during rehabilitation in cirrhotic patients with sarcopenia has never been studied and is worth exploring.
Furthermore, from our previous study, the investigators have shown that one-year efficacy of rifaximin add-on to lactulose is superior to lactulose alone in patients with cirrhosis complicated with recurrent HE in Taiwan. The investigators also have preliminary data showing that rehabilitation could improve patient's sarcopenia. Further cohort validation is urgently required.
Our innovative research purposes:
- To explore the changes of fecal microbiota before and after treatment such as resistance training rehabilitation as a reference for future fecal microbiota transplantation;
- To measure the changes of sarcopenia levels before and after rehabilitation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Training | Experimental | Behavioral: Rehabilitation TrainingRehabilitation Training is provided to patients with Liver Cirrhosis combined with sarcopenia. |
| No-Rehabilitation Training | No intervention | –No extra training is provided to patients with Liver Cirrhosis combined with sarcopenia. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with liver cirrhosis
Key exclusion criteria (10 listed)
- unstable vital sign such as shock, coma or intubation status
- Non-curative hepatocellular carcinoma (cannot receive operation, radiofrequency ablation, liver transplantation,etc
- Un-curative malignancies
- Poor-controlled diabetes mellitus (HbA1C≧8)
- Active alcoholism (male alcohol ≧40g/day, or ≧140g/week; female ≧ 30g/day, or ≧70g/week
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 |
|---|---|---|
| Rehabilitation Training12 week Rehabilitation Training course | Behavioural | Rehabilitation Training |
Primary outcome
Handgrip Strength
Time frame: 6 months
Handgrip strength is an assessment of muscle strength. The cutoff value of the handgrip is < 30 kg in men and < 20 kg in women.
Short Physical Performance Battery (SPPB)
Time frame: 6 months
Short Physical Performance Battery (SPPB) is an assessment of physical performance. The cut-off value of the Short Physical Performance Battery (SPPB) score for determining sarcopenia is ≤ 9.
Dual-energy X-ray absorptiometry (DEXA)
Time frame: 6 months
Dual-energy X-ray absorptiometry (DXA) is the gold-standard technique in the analysis of body composition. The cut-off value of appendicular skeletal muscle mass (ASMI) score for determining sarcopenia is < 7.0 kg/m^2 in men and < 5.4 kg/m^2 in women.
Mini-Mental Status Examination (MMSE)
Time frame: 6 months
Mini-Mental State Examination (MMSE) is one of the most commonly used methods in the assessment of cognitive mental status. The cut-off value of Mini-Mental State Examination (MMSE) score is < 28.
Psychometric Hepatic Encephalopathy Score (PHES)
Time frame: 6 months
The psychometric hepatic encephalopathy score (PHES) is the gold standard for diagnosing minimal hepatic encephalopathy (MHE). The cut-off value of the Psychometric Hepatic Encephalopathy Score (PHES) for determining minimal hepatic encephalopathy (MHE) is ≤ -4.
Animal Naming Test (ANT)
Time frame: 6 months
The animal naming test (ANT) is an easy tool for the assessment of hepatic encephalopathy (HE). The cut-off value of the Animal Naming Test (ANT) score for determining hepatic encephalopathy (HE) is ≤ 19.
Blood cytokine levels [IL-6]
Time frame: 6 months
Serum IL-6 level (pg/ mL)
Blood ammonia levels [NH3]
Time frame: 6 months
Serum ammonia level (μg/dL)
Electroencephalogram (EEG)
Time frame: 6 months
Quantified EEG spectral analysis: Grade 0: Mean dominant frequency (MDF)> 6.8 Hz and no theta nor delta wave Grade 1: MDF > 6.8Hz and theta wave relative power ≧35% Grade 2: MDF≤ 6.8 Hz and delta wave relative power<49% Grade 3: MDF≤ 6.8 Hz and delta wave relative power≧49%
Fecal Microbiota
Time frame: 6 months
Check fecal microbiota taxonomy profile and relative abundance changes.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
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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.
CHIEN-HAO HUANG principal investigator
Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation Training in people with Hepatic Encephalopathy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 10 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 18 Sep 2023. 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 Taiwan. 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?
Contact CHIEN-HAO HUANG, MD (+886 9753 66128, q12248@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handgrip Strength (time frame: 6 months). The study lists 10 primary outcomes in all. 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 18 Sep 2023.