The purpose of this study was to evaluate the effect of probiotics in non-alcoholic fatty liver disease in children.
Children and adolescents with non-alcoholic fatty liver disease, aged 10 to 18 years with a body mass of 85 percent and are selected.
Exclusion criteria included alcohol consumption, the presence of other liver diseases and drug history is about.
Patients with non-alcoholic fatty liver disease among children with gastrointestinal outpatient clinic of children go to be elected.
The sample size is calculated to be at least 64 patients randomly divided into two groups. Pokid capsule orally once daily for the intervention group and the control group received a placebo daily capsule that is similar to the original drug is given for 12 weeks. Before and after intervention liver enzymes and liver ultrasound is done and compared
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013100414882N1
Registration date:2015-06-02, 1394/03/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-06-02, 1394/03/12
Registrant information
Name
Fatemeh Famouri
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3663 7291
Email address
famouri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-04-20, 1393/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effect of Probiotics on Nonalcoholic Fatty Liver Disease in Obese or Overweight Children and Adolescents 10-18 years
Public title
Evaluation of Effect of Probiotics on Nonalcoholic Fatty Liver Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children and adolescents with fatty liver disease; 10-18 years; BMI=> 85%
Exclusion criteria: alcohol ingestion; other baseline liver disease; ingestion of medication
Age
From 10 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Ethic Commitee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Postal code
81746-73461
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
393891
Health conditions studied
1
Description of health condition studied
non alcoholic fatty liver disease
ICD-10 code
k75.8
ICD-10 code description
nonalcoholic steatohepatitis
Primary outcomes
1
Description
liver aminotransferase level
Timepoint
before and 12 weeks after intervention
Method of measurement
biochemical laboratory testes
2
Description
grade of fatty liver
Timepoint
before and 12 weeks after intervention
Method of measurement
sonography
Secondary outcomes
1
Description
lipid profiles
Timepoint
before and 12 weeks after intervention
Method of measurement
biochemical laboratory testes
Intervention groups
1
Description
The treatment group recieved one prokid capsule daily oral for a duration of 12 weeks.
Category
Treatment - Drugs
2
Description
The placebo group recieved one placebo capsule( similar in shape, color, and size) daily oral for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatrics Gastroenterology Clinic
Full name of responsible person
Dr. Fatemeh Famouri
Street address
Imam Hossein Hospital, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Mansur Siyavash
Street address
Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences
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
Child Growth and Development Center and Pediatic Group of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Zeinab Shariat
Position
Pediatic Resident
Other areas of specialty/work
Street address
Imam Hossein Hospita, Isfahan, Iran
City
Isfahan
Postal code
81746-73461
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
zshariat@yahoo.com
Web page address
mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Child Growth and Development Centrer and Pediatric Group of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Fatemeh Famouri
Position
Assistant Professor, Gastrointestinal and Hepatology Subspecialist
Other areas of specialty/work
Street address
Imam Hossein Hosppital, Isfahan, Iran
City
Isfahan
Postal code
81746-73461
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
famouri@med.mui.ac.ir
Web page address
www.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Child Growth and Development Center and Pediatric Group of Isfahan University of Medical Sciences
Full name of responsible person
Dr. Roya Kelishadi
Position
Professor/ Pediatrition
Other areas of specialty/work
Street address
Imam Hossein Hospital, Isfahan, Iran
City
Isfahan
Postal code
81746-73461
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
kelishadi@med.mui.ac.ir
Web page address
mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)