This study aimed to investigate the effect of Familact probiotic in the treatment of patients with NAFLD, as a clinical trial study. And 90 patients with proven NAFLD by ultrasonography and ALT more than 1.5 to 5 times the normal, BMI between 25 to 29.9 with the written consent referred to the gastroenterology clinic in Vali Asr hospital or private offices to be studied. And weight, blood pressure, BMI, liver function tests, blood glucose, and lipid profiles are analyzed. Both groups will be referred to a dietitian. Then randomly divided into two groups (45 people). The control group will have a daily exercise for at least 30 minutes. And the second group will receive Familact capsule 500 mg once daily after a meal. After eight weeks of starting treatment the above cases, re-evaluated by same person in the same laboratory unit. Information collected will be evaluated and compared. And Familact impact in the treatment of NAFLD and reducing liver enzymes checked.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014112019554N2
Registration date:2015-07-12, 1394/04/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-12, 1394/04/21
Registrant information
Name
Maryam Jameshorani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00989126416972 و 00982433770805
Email address
dr.shirinjameshorani@zumc.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment effects of familact Probiotic in Non Alcoholic Fatty Liver Disease(NAFLD)
Public title
Treatment effects of familact Probiotic in Non Alcoholic Fatty Liver Disease(NAFLD)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with NAFLD on ultrasonography; ALT more than 1.5 to 5 times the normal range; BMI between 25 to 29.9
Exclusion criteria: alcoholic hepatitis; systemic or metabolic or inflammatory disease such as diabetes; viral hepatitis; autoimmune hepatitis; secondary fatty liver disease such as drug induced fatty liver disease
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
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
Zanjan University of Medical Sciences
Street address
Medical School, Zanjan University of Medical Sciences, Karmandan street, Zanjan
City
Zanjan
Postal code
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
A-12-500-5
Health conditions studied
1
Description of health condition studied
Nonalcoholic steatohepatitis
ICD-10 code
K75.8
ICD-10 code description
Other specified inflammatory liver diseases, Nonalcoholic steatohepatitis [NASH]
Primary outcomes
1
Description
Blood pressure
Timepoint
at the first and after 8 weeks
Method of measurement
Manometer
2
Description
body mass index
Timepoint
at the first and after 8 weeks
Method of measurement
Analog scale, Meter
3
Description
fasting blood glucose
Timepoint
at the first and after 8 weeks
Method of measurement
ELISA
4
Description
total cholestrol
Timepoint
at the first and after 8 weeks
Method of measurement
ELISA
5
Description
LDL
Timepoint
at the first and after 8 weeks
Method of measurement
ELISA
6
Description
HDLا
Timepoint
at the first and after 8 weeks
Method of measurement
ELISA
7
Description
TG
Timepoint
at the first and after 8 weeks
Method of measurement
ELISA
8
Description
AST
Timepoint
at the first and after 8 weeks
Method of measurement
ELISA
9
Description
ALT
Timepoint
at the first and after 8 weeks
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Daily exercise for at least 30 minutes
Category
Lifestyle
2
Description
Familact capsule 500 mg once daily after a meal
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Dr.Maryam Jameshorani
Street address
Valiasr Hospital, Valiasr Sq, Zanjan
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences, Deputy of Research and Technology, Research Management
Full name of responsible person
Dr. Soghrat Faghihzadeh
Street address
Medical School, Zanjan University of Medical Sciences, Karmandan street, Zanjan
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences, Deputy of Research and Technology, Research Management
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Maryam Jameshorani
Position
Internist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Sq, Zanjan
City
Zanjan
Postal code
Phone
00
Fax
Email
dr.shirinjameshorani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Maryam Jameshorani
Position
Internist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Sq, Zanjan
City
Zanjan
Postal code
Phone
00
Fax
Email
dr.shirinjameshorani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Maryam Jameshorani
Position
Internist
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Sq, Zanjan
City
Zanjan
Postal code
Phone
00
Fax
Email
dr.shirinjameshorani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)