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(HE) in cirrhotic patients
Design
A randomized, non-blind controlled trial with three intervention groups on 120 cirrhotic patients
Settings and conduct
Patients with cirrhosis who had recovered from an episode of HE in both Sina and Emam Reza Hospital were assigned randomly to 4 groups. Before starting the study and at the end, psychometric performance, blood ammonia levels and quality of life, will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients between ages 18-80 years, Cirrhotic patients who had recovered from an episode of hepatic HE. 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
Intervention groups
Intervention group: The first treatment 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 group: The second treatment 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 group: The third treatment 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: Control group consists of 30 patients receiving 30 mL of Lactulose 4 times a day for 3 months.
Main outcome variables
Recurrence of HE
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170609034406N9
Registration date:2021-09-01, 1400/06/10
Registration timing:prospective
Last update:2021-09-01, 1400/06/10
Update count:0
Registration date
2021-09-01, 1400/06/10
Registrant information
Name
Afshin Gharekhani
Name of organization / entity
Faculty of Pharmacy/Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 1315
Email address
gharekhania@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-04-19, 1401/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of probiotic and zinc combination therapy for the prevention of recurrence of Hepatic encephalopathy (secondary prophylaxis) in cirrhotic patients
Public title
The effect of probiotic and zinc combination therapy for the prevention of recurrence of Hepatic encephalopathy (secondary prophylaxis) in cirrhotic patients
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
No 2 central building , Tabriz University of Medical sciences , Golgasht Street , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2021-03-01, 1399/12/11
Ethics committee reference number
IR.TBZMED.REC.1399.1144
Health conditions studied
1
Description of health condition studied
Chronic hepatic failure
ICD-10 code
K72.1
ICD-10 code description
Chronic hepatic failure
2
Description of health condition studied
Hepatic Encephalopathy
ICD-10 code
G94.3
ICD-10 code description
Encephalopathy in diseases classified elsewhere
Primary outcomes
1
Description
Blood ammonia levels
Timepoint
Immediately before intervention, At the end of the intervention (3 months from baseline)
Method of measurement
Pathobiology laboratory
2
Description
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
3
Description
Recurrence of Hepatic Encephalopathy
Timepoint
At the end of the intervention (3 months from baseline)
Method of measurement
Patient medical file
Secondary outcomes
1
Description
Quality of life
Timepoint
Immediately before intervention, At the end of the intervention (3 months from baseline)
Method of measurement
SF36 health survey questionnaire
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
3
Description
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.
Category
Treatment - Drugs
4
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Afshin Gharekhani
Street address
Sina Medical Research and Training Hospital Shahid Montazeri and Hafez squares Azadi Street Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5163639888
Phone
+98 41 3549 8342
Email
gharekhania@yahoo.com
2
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Afshin Gharekhani
Street address
Golgasht street_ Emam Reza Medical Research and Training Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Email
gharekhania@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Afshin Gharekhani
Street address
No 2 central building, Tabriz University of Medical sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5766414766
Phone
+98 41 3337 2250
Email
gharekhania@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Tabriz University of Medical Science , Daneshgah Street , Tabriz , Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5351
Email
gharekhania@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Afshin Gharekhani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy , Tabriz University of Medical Science , Daneshgah Street , Tabriz , Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5153
Email
gharekhania@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Leila amooyi
Position
Pharmacy Student
Latest degree
Bachelor
Other areas of specialty/work
Medical Pharmacy
Street address
Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5147663419
Phone
+98 41 3230 5153
Email
leila.amooyi.d@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available