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IRCT20170609034406N9 IRCT 2021-09-01 Tabriz University of Medical Sciences 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 2021-09-23 anticipated 120 Complete https://irct.ir/trial/50941 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, Permuted Block Randomization method will be used for assigning patients with equal ratio to four groups A, B, C, D. There will be 6 blocks of 8 and 6 blocks of 12 patients With different sequences and codes from 1 to 12. In this study random numbers between 1 to 12 will be given using the Excel software to determine blocks randomly and form a random chain of 4 groups. 3 Condition 1: Chronic hepatic failure. Condition 2: Hepatic Encephalopathy. 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: Second intervention group: consists of 30 patients receiving 25 mg Zinc Gluconate per day and 30 mL of Lactulose 4 times a day for 3 months. Intervention 3: Third intervention group: consists of 30 patients receiving 1 Comflor Probiotic capsule(450 billion CFU) twice a day and 25 mg Zinc Gluconate per day and 30 mL of Lactulose 4 times a day for 3 months. Intervention 4: Control group: consists of 30 patients receiving 30 mL of Lactulose 4 times a day to produce 2 to 3 soft stools per day for 3 moths. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Afshin Gharekhani
Faculty of Pharmacy, Tabriz University of Medical Science , Daneshgah Street , Tabriz , Iran
Tabriz Iran (Islamic Republic of) 5147663419 +98 41 3230 5351 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Afshin Gharekhani
Faculty of Pharmacy , Tabriz University of Medical Science , Daneshgah Street , Tabriz , Iran
Tabriz Iran (Islamic Republic of) 5147663419 +98 41 3230 5153 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients between ages 18 and 80 years Cirrhotic patients who had recovered from an episode of overt hepatic encephalopathy 18 years 80 years Both 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 K72.1 G94.3 Chronic hepatic failure Encephalopathy in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs 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. Second intervention group: consists of 30 patients receiving 25 mg Zinc Gluconate per day and 30 mL of Lactulose 4 times a day for 3 months. Third intervention group: consists of 30 patients receiving 1 Comflor Probiotic capsule(450 billion CFU) twice a day and 25 mg Zinc Gluconate per day and 30 mL of Lactulose 4 times a day for 3 months. Control group: consists of 30 patients receiving 30 mL of Lactulose 4 times a day to produce 2 to 3 soft stools per day for 3 moths. 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. Quality of life. Timepoint: Immediately before intervention, At the end of the intervention (3 months from baseline). Method of measurement: SF36 health survey questionnaire. Tabriz University of Medical Sciences Approved 2021-03-01 Ethics Committee of Tabriz University of Medical Sciences No 2 central building , Tabriz University of Medical sciences , Golgasht Street , Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)