Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: Fecal Microbiota transplantation: Subjects will receive FMT on day-0 and day 30, route of administration is oral. Once for 2 months
Control Intervention1: Lactulose alone: Subjects will
Sponsors
All India Institute of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age =18 years - 60 years 2. Cirrhosis (diagnosed based on biopsy, radiology, fibroscan or imaging evidence of portal hypertension) 3. Willing and able to comply with the FMT regimen and all other study requirements 4. The patient or guardian can provide written informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Cirrhosis with Overt HE 2. Pregnant or breastfeeding. Women of childbearing potential will be screened with beta-human chorionic gonadotropin (hCG). 3. Those receiving immunosuppression therapy 4. People living with HIV (PLHIV) 5. History of spontaneous bacterial peritonitis 6. Model for End-stage Liver disease score >18 7. Low protein ( 8. Medical conditions that require prolonged or frequent use of systemic acyclovir or famciclovir (e.g., for recurrent herpes virus infections, etc). Prolonged use means episodic treatment with these agents for 10 days every 3 months or chronic suppressive therapy. 9. Acute variceal bleeding within last 4 weeks 10. Patients with acute on chronic liver failure (ACLF) 11. Patients with hepatocellular carcinoma (HCC) 12. Patients with a spontaneous portosystemic shunt (as diagnosed on CT scan) 13. Patients with alcohol consumption of more than 30 gm of ethanol or abusing illicit drugs within last 1 month. 14. Medical conditions, requiring potentially hepatotoxic drugs (e.g. dapsone, erythromycin, fluconazole, ketoconazole, rifampin, anti-tuberculosis regimens, others) or nephrotoxic drugs (e.g., frequent NSAIDs, aminoglycosides, amphotericin B, foscarnet). 15. Patients on warfarin or other anticoagulants for 30 days prior to screening or if expected during the present study. 16. 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, repeated myocardial infarction or congestive heart failure, renal insufficiency, uncontrolled asthma or diabetes, unstable thyroid disease or other significant hormonal conditions, uncontrolled seizure disorders, severe psychiatric disorders, active tuberculosis under current treatment, etc) 17. Patient on antibiotics 18. Patient on Renal replacement therapy 19. Patients with a history of surgery within the last 3 months 20. Patients with an active autoimmune liver disease requiring treatment with steroids and immunomodulators (we should not exclude these patients) 21. Post TIPSS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the differences in the improvement (resolution) of MHE in the 2 groups: faecal microbiota transplantation and control armTimepoint: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the proportion of patients with MHE developing overt HE between the 2 groups. 2.To evaluate gut microbiome composition at baseline (before FMT), at 30 days, and 90 days of FMT in this cohort of patients 3.To assess the safety, including the incidence of clinical adverse events and incidence of laboratory abnormality after FMT 4.To assess the changes in Child-Turcotte-Pugh (CTP) score and model for end stage liver disease (MELD) score between the 2 groups. 5.Change in PHES score between the 2 groups 6.Differences in the ammonia levels between the 2 groups at baseline, 4 weeks, and 3 months. 7.To assess transplant free survival at 0, 28, and 90 days. 8.Patients will be followed monthly after completion of therapy as part of routine care for clinical and biochemical assessment 9.Assessment of cytokines - IL6, IL1, IL18, TNF-alphaTimepoint: 1. 3 months 2. 30 and 90 days 3. 3 months 4. 3 months 5. 3 months 6. 4 weeks and 3 months 7. 0,28,90 days 8. 3 months 9. 3 months | — |
Countries
India
Contacts
Public ContactDr Ankit agarwal
All India Institute of Medical Sciences
Outcome results
None listed