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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20170609034406N9
Enrollment
120
Registered
2021-09-01
Start date
2021-09-23
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Chronic hepatic failure. Condition 2: Hepatic Encephalopathy. Chronic hepatic failure Encephalopathy in diseases classified elsewhere

Interventions

Intervention 1: First Intervention group: consists of 30 patients receiving 1 Comflor Probiotic capsule(450 billion CFU) twice a day and 30 mL of Lactulose 4 times a day for 3 months. Intervention 2:

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfshin Gharekhani

Tabriz University of Medical Sciences

gharekhania@tbzmed.ac.ir+98 41 3230 5351

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 5, 2026