The effect of probiotic and zinc combination therapy for the prevention of recurrence of Hepatic encephalopathy (secondary prophylaxis) in cirrhotic patients

Phase 3

Recruiting

Conditions: Condition 1: Chronic hepatic failure. Condition 2: Hepatic Encephalopathy.
Chronic hepatic failure
Encephalopathy in diseases classified elsewhere
K72.1
G94.3

Registration Number: IRCT20170609034406N9

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

Patients between ages 18 and 80 years
Cirrhotic patients who had recovered from an episode of overt hepatic encephalopathy

Exclusion Criteria

Patients on probiotic therapy
History of alcohol intake during the past 6 weeks
Active infection at the time of enrollment in the study
Previous transjugular intrahepatic portosystemic shunt or shunt surgery
Renal failure
Use of psychoactive drugs, such as antidepressants or sedatives
Any neurologic diseases, such as Alzheimer’s disease, Parkinson’s disease, and Non hepatic metabolic encephalopathies

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood ammonia levels. Timepoint: Immediately before intervention, At the end of the intervention (3 months from baseline). Method of measurement: Pathobiology laboratory.;Psychometric performance. Timepoint: Immediately before intervention, At the end of the intervention (3 months from baseline). Method of measurement: Trail making task A, Trail making task B, Symbol digit modality task.;Recurrence of Hepatic Encephalopathy. Timepoint: At the end of the intervention (3 months from baseline). Method of measurement: Patient medical file.

Secondary Outcome Measures

Name	Time	Method
Quality of life. Timepoint: Immediately before intervention, At the end of the intervention (3 months from baseline). Method of measurement: SF36 health survey questionnaire.