Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Fecal microbiota transplantation plus Standard medical treatment: Fresh fecal material, within 6 hours after defecation, will be used. The storage and preparation will be as brief as po
Sponsors
All India Institute of medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cirrhosis patients undergoing TIPSS for any indications 2. Willing and able to comply with the FMT regimen and all other study requirements 3. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Age greater than 75 years 2. Pregnant or lactating woman 3. People living with HIV 4. Patients with low ejection fraction EF less than 50 percent 5. Those undergoing rescue or pre-emptive TIPS for variceal bleed Patients with severe TR, severe PAH mean Pulmonary Artery Pressure greater than 45 mmHg Active sepsis Polycystic liver disease Biliary obstruction Patients with history of congestive heart failure Patients with Chronic Kidney disease eGFR less than 60 ml per min per 1.73m2 for greater than 3 months Model for End-stage Liver disease score greater than 18 Patients with acute-on-chronic liver failure ACLF as defined by the European Association for Study of the Liver Patients with hepatocellular carcinoma Refusal to give consent Concurrent diseases which would require use of antibiotics Patients with history of overt or persistent HE Any other known neurological disorders Other concurrent medical conditions likely to preclude compliance with the schedule of evaluations in the protocol or likely to confound the efficacy or safety observations of the study e.g., concurrent malignancies, history of unstable angina, myocardial infarction, uncontrolled asthma or diabetes, unstable thyroid disease or other significant hormonal conditions, uncontrolled seizure disorders, severe psychiatric disorders, active tuberculosis under current treatment, etc Any contraindication for TIPS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the occurrence of overt hepatic encephalopathy between the two groups at 6 months after TIPSTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Differences in the MHE by Psychometric hepatic encephalopathy score between the 2 groups at 6 months after TIPS 2.Comparison of changes in ammonia levels between the 2 groups 3. Comparison of changes in microbiome from preFMT to day 14 day of TIPS in between the 2 groups 4. Correlation of Stool microbiome with P/TIPSS HE 5. Adverse events in the two groups 6. Differences in the quality of life in the two groups using the Short Form 36 questionnaire 7. Association of sarcopenia and nutritional status with p/TIPSS HETimepoint: 1. 6 months 2. 6 months 3. 14 days 4. 6 months 5. 6 months 6. 6 months 7. 6 months | — |
Countries
India
Contacts
Public ContactDr Vishal Singh Chauhan
All India Institute of Medical Sciences
Outcome results
None listed