Health Condition 1: K746- Other and unspecified cirrhosis ofliver
Conditions
Interventions
Intervention1: PROBIOTIC: The intervention group will receive Probiotic along with the standard medical therapy where as the comparator arm will receive only standard medical treatment
Control Interve
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years. 2. Patient of decompensated cirrhosis of any aetiology. 3. Presence of frailty.
Exclusion criteria
Exclusion criteria: 1. Patients with CTP score more than 10 2. Patients with allergy to probiotics 3. Patient with acute on chronic liver failure (ACLF) 4. Patients with active malignancy, hepatocellular carcinoma and end- stage renal disease 5. Patients having prior study enrolment or enrolment in another conflicting study. 6. Patients, who are not willing to participate in the study. 7. Patients who are participating in other clinical trials within past 3 months. 8. Patients who has an active evidence of infection 9. Patients who had acute organic brain disease in the past 6 months 10.Patients who has severe hemodynamic instability, serious heart disease, severe bradycardia or tachycardia at rest 11. Patients having renal failure (creatinine clearance rate ?60 mL/min/1.73 m2). 12. Patients with severe cognitive impairment, overt hepatic encephalopathy or patients who had physical disability. 13. Patients with HIV 14. Pregnancy 15. Post liver transplant patients 16. Exposure to probiotics in the previous 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To see the effect of probiotics on frailty in decompensated cirrhosis as measured by Liver Frailty Index (LFI)Timepoint: To see the effect of probiotics on frailty in decompensated cirrhosis as measured by Liver Frailty Index (LFI) at three and six months | — |
Secondary
| Measure | Time frame |
|---|---|
| To see change in prognostic scores (CTP/ MELD/ MELD Na) at 6 month •To see change in levels of inflammatory markers and ammonia at 6 month •To see change in sarcopenia (skeletal muscle at L3 vertebral level on CT) at 6 month •Survival & hospitalisation •Change in quality of life at 6 month •Adverse events as per World Health Organization (WHO grading)Timepoint: Patients will be enrolled in an expected period of 18 months Patients will be followed up for their final outcomes for next 6 months with measurements of various outcomes at baseline, three and at 6 month | — |
Countries
India
Contacts
Public ContactSAVNEET SINGH
PGIMER ,CHANDIGARH
Outcome results
None listed