Effects of probiotic and metformin on nonalcolic steatohepatitisin patients admitted to Al Zahra hospital
Sixty three Patients 18-75 years with biopsy-confirmed NASH were enrolled to study. Patients were randomized to one of the following treatments during 6 months: group I, treated with Protexin two tablets per day plus Metformin 500 mg two tablets per day(Met/Pro) and group II, treated with Metformin 500 mg two tablets per day plus two placebo tablet (Met/P). After six month Alanine aminotransferase(ALT), Aspartate aminotransferans,TG , FBS, cholesterol, CBC and ultrasound grading of NASH were measured. Before and after intervention ultrasound was performed to determine of NASH grade by one radiologist(Grade 0 normal, grade 1 mild, grade 2 moderate, grade 3 severe). any participant who will take antibiotics for any indication for more than 1 week during the study period or before recruitment to the study; loosing more than 10% of baseline body weight during the study period; autoimmune hepatitis; Wilson's disease; HBV/HCV/HIV/EBV/CMV infection; pregnancy and lactation.
General information
Acronym
NASH nonalcolic steatohepatitis
IRCT registration information
IRCT registration number:IRCT201204049376N1
Registration date:2012-07-05, 1391/04/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-07-05, 1391/04/15
Registrant information
Name
Hassan Firouzian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1651 1629
Email address
hassan_firoozian@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2010-11-21, 1389/08/30
Expected recruitment end date
2012-04-19, 1391/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of probiotic and metformin on nonalcolic steatohepatitis: a double blind randomized clinical trial.
Public title
Effects of probiotic on nonalcolic steatohepatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients admitted to Al Zahra hospital over 18 years, who have NASH confirmed by biopsy.
Exclusion criteria: any participant who will take antibiotics for any indication for more than 1 week during the study period or before recruitment to the study; loosing more than 10% of baseline body weight during the study period; autoimmune hepatitis; Wilson's disease; HBV/HCV/HIV/EBV/CMV infection; pregnancy and lactation
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences Ethics Committee
Street address
Vice Chancellor for Research of medical university of Isfehan.Hezar Jarib Ave, Isfehan
City
Isfahan
Postal code
Approval date
2010-10-23, 1389/08/01
Ethics committee reference number
391058
Health conditions studied
1
Description of health condition studied
Nonalcoholic steatohepatitis
ICD-10 code
K75.9
ICD-10 code description
Inflammatory liver disease, unspecified Hepatitis NOS
Primary outcomes
1
Description
Alanine transaminase (ALT)
Timepoint
Before and after treatment
Method of measurement
Blood test
2
Description
Aspartate aminotransferse (AST)
Timepoint
before and after treatment
Method of measurement
blood test AST
3
Description
ultrasound Grade of NASH
Timepoint
before and after treatment
Method of measurement
ultrasound
Secondary outcomes
1
Description
fasting blood suger (FBS)
Timepoint
before and after treatment
Method of measurement
blood test
2
Description
chlosterol
Timepoint
befoer and after treatment
Method of measurement
blood test
3
Description
triglyceride
Timepoint
before and after treatment
Method of measurement
blood test
4
Description
body mass index (BMI)
Timepoint
before and after treatment
Method of measurement
measure weight and height
Intervention groups
1
Description
Control group: treated with Metformin 500 mg two tablets per day plus two placebo tablet two tablets per day for six month
Category
Behavior
2
Description
Protexin two tablets per day plus Metformin 500 mg two tablets per day for six month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra university hospital
Full name of responsible person
Hassan Firouzian gastrointestinal fellow
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Peiman Adibi
Street address
Vice Chancellery for Research, Isfahan University of Medical Sciences,Hezar jarib Ave
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?