Microbiota, Sarcopenia, and Hepatic Encephalopathy Change in Cirrhotic Patients Before and After Rehabilitation

NCT06040814 | Unknown

• 1 other identifier: 202201561B0
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 1.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;
2. 2.To measure the changes of sarcopenia level before and after rehabilitation;
3. 3.To measure the changes of hepatic encephalopathy level before and after rehabilitation.

Conditions

Hepatic Encephalopathy

Keywords

Liver cirrhosis; Hepatic encephalopathy; Psychometric test; Sarcopenia; Fecal microbiota

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  6 months

• Blood cytokine levels [IL-6]

  Serum IL-6 level (pg/ mL)

  6 months

• Blood ammonia levels [NH3]

  Serum ammonia level (μg/dL)

  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%

  6 months

• Fecal Microbiota

  Check fecal microbiota taxonomy profile and relative abundance changes.

  6 months

Study Arms (2)

Rehabilitation Training

EXPERIMENTAL

Rehabilitation Training is provided to patients with Liver Cirrhosis combined with sarcopenia.

Behavioral: Rehabilitation Training

No-Rehabilitation Training

NO INTERVENTION

No extra training is provided to patients with Liver Cirrhosis combined with sarcopenia.

Interventions

Rehabilitation Training BEHAVIORAL

12 week Rehabilitation Training course

Rehabilitation Training

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with liver cirrhosis

You may not qualify if:

• 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
• Neurologic comorbidities like Alzheimer's, Parkinson's, stroke with neurological deficit
• Unable to speak
• Bed-ridden status
• Post- Liver transplantation.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy; Liver Cirrhosis; Sarcopenia

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Study Officials

• CHIEN-HAO HUANG

  Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHIEN-HAO HUANG, MD

CONTACT

+886 9753 66128; q12248@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 18, 2023
• Study Start: December 1, 2022
• Primary Completion: November 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 18, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)