Using fecal microbiota transplantation to treat liver cirrhosis
Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
This study tests whether a treatment using fecal microbiota transplantation can help improve liver function in people with liver cirrhosis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academic Emergency County Hospital Sibiu Academic / other |
| Locations | 1 site (Sibiu) |
| Trial ID | NCT06478602 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of fecal microbiota transplantation in patients diagnosed with liver cirrhosis, regardless of the underlying cause. The approach aims to modulate the gut microbiome to potentially improve liver function and patient outcomes. Participants will undergo fecal transplantation as a therapeutic intervention, and their progress will be monitored throughout the study. The study is designed to assess the safety and efficacy of this treatment in a Phase 3 clinical setting.
Who should consider this trial
Good fit: Ideal candidates are adult patients diagnosed with liver cirrhosis who are conscious and cooperative.
Not a fit: Patients with severe hemodynamic or respiratory instability, or those with contraindications for fecal transplantation, will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel therapeutic option for patients suffering from liver cirrhosis.
How similar studies have performed: Other studies have shown promising results with fecal microbiota transplantation for various gastrointestinal conditions, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of liver cirrhosis according to current protocols. * Conscious and cooperative adult patients. Exclusion Criteria: * Patients with hemodynamic and/or respiratory instability. * Patients with contraindications for colonoscopy or fecal transplantation. * Patients with acute or chronic infections with HIV, Tuberculosis, MDR Enterobacteria, CMV, parasites, fungi. * Associated oncological pathology. * Patients with other causes of severe immunodeficiencies. * Lack of compliance with the conditions imposed by the research project. * Patients who do not sign the informed consent.
Where this trial is running
Sibiu
- County Clinical Emergency Hospital of Sibiu — Sibiu, Romania (Recruiting)
Study contacts
- Study coordinator: Cristian Ichim, Resident Doctor
- Email: cristian.ichim@ulbsibiu.ro
- Phone: 0040771643848
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.