Exploring gut bacteria changes in cirrhotic patients undergoing rehabilitation
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
NA · Chang Gung Memorial Hospital · NCT06040814
This study is testing how rehabilitation training affects gut bacteria and symptoms like muscle loss and confusion in people with liver cirrhosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital (other) |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT06040814 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of rehabilitation training on fecal microbiota, sarcopenia, and hepatic encephalopathy in patients with liver cirrhosis. It aims to measure changes in gut bacteria and the severity of sarcopenia and hepatic encephalopathy before and after rehabilitation. The findings could provide insights for future treatments, including fecal microbiota transplantation, and improve patient outcomes. The study addresses a critical gap in understanding the gut-liver-brain axis in cirrhotic patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with liver cirrhosis.
Not a fit: Patients with unstable vital signs, active malignancies, or significant psychiatric or neurological comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies and treatment options for patients with liver cirrhosis, potentially reducing complications and healthcare costs.
How similar studies have performed: While the specific dynamic changes of microbiota during rehabilitation in cirrhotic patients have not been extensively studied, related research has shown promising results in understanding the gut-liver connection.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with liver cirrhosis Exclusion Criteria: * 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.
Where this trial is running
Taoyuan
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (RECRUITING)
Study contacts
- Principal investigator: CHIEN-HAO HUANG — Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan
- Study coordinator: CHIEN-HAO HUANG, MD
- Email: q12248@cgmh.org.tw
- Phone: +886 9753 66128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatic Encephalopathy, Liver cirrhosis, Hepatic encephalopathy, Psychometric test, Sarcopenia, Fecal microbiota