nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in children and adults. There is no effective treatment for thiis disease. Recently, probiotics are suggested as possible treatment.The aim of current study is to evaluate the efficacy of probiotic Gerilact in NAFLD patients. In this double-blinded randomized clinical trial, 60 patients with NAFLD with inclusion criteria and not having exclusion criteria will be recruited and using random numbers and sealed envelopes will randomly assigned to Gerilact or placebo groups. Patients will receive Gerilact 500 mg or placebo twice a day for 60 days. Inclusion criteria are NAFLD grade II and III, BMI 25-40 kg/m2 and over 18 years old. Exclusion criteria will be any systemic or chronic liver disease beside NAFLD, cancer, antibiotic therapy two weeks prior or during to study, complement use, alcohol use and pregnancy. Lipid profile, liver function test and sonography will be evaluated before and at the end of the intervention.In this triple blinded study, the patients, physician and the person responsible to collect data will be blinded to the allocated group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017102537007N1
Registration date:2017-11-12, 1396/08/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-12, 1396/08/21
Registrant information
Name
Zahra Sadeghi
Name of organization / entity
Ardabil University of Medical Scineces
Country
Iran (Islamic Republic of)
Phone
+98 45 3352 2391
Email address
z.sadeghi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of Ardabil University of Medical Sciecnes
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic in improving laboratory findings in nonalcoholic fatty liver disease
Public title
Effect of probiotic in improving laboratory findings in nonalcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with newly diagnosed fatty liver grade II and III; with no treatment for NAFLD; BMI 25-40 kg/m2; over 18 years old.
Exclusion criteria: any gastrointestinal disease; diabetes mellitus; cardiac or kidney failure; thyroid disease; rheumatoid arthritis; chronic liver disease beside NAFLD; cancer; antibiotic therapy two weeks prior or during study; vitamin, antioxidant, fiber and omega3 complement use 3 weeks prior or during study; pregnancy or breast feeding, OCP use; liver transplantation; alcohol use.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ardabil University of Medicine Sciences Ethics committee
Street address
Ardabil University of Medicine Sciences, Daneshgah St.,
City
Ardabil
Postal code
53141-56198
Approval date
2017-10-07, 1396/07/15
Ethics committee reference number
IR.ARUMS.REC.1396.109
Health conditions studied
1
Description of health condition studied
Nonalcoholic fatty liver disease (NAFLD)
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Lipid profile
Timepoint
Before and at the end of intervention
Method of measurement
with laboratory examination
2
Description
Liver function tests
Timepoint
Before and at the end of intervention
Method of measurement
with laboratory examination
3
Description
Fatty liver grade
Timepoint
Before and at the end of intervention
Method of measurement
With sonography
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, two Gerilact tablets 500 mg will be administered daily for 60 days
Category
Treatment - Drugs
2
Description
In control group, two placebo tablets will be given daily for 60 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital, Ardabil
Full name of responsible person
Dr. Zahra Sadeghi
Street address
Imam Khomeini Hospital, Ataei Ave.,
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ardabil University of Medical Sciences
Full name of responsible person
Dr. Masoud Entezari Asl
Street address
Ardabil University of Medical Sciences, Daneshgah St.,
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ardabil 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
Ardabil University of Medical Sceinces
Full name of responsible person
Dr. Zahra Sadeghi
Position
Internal medicine resident
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences, Daneshgah St.,
City
Ardabil
Postal code
Phone
+98 45 3325 1401
Fax
Email
z.sadeghi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Seyyed Mohammad Sadr Kabir
Position
Assistant professor
Other areas of specialty/work
Street address
ardabil University of Medical Sciences, Daneshgah St.,
City
Ardabil
Postal code
Phone
+98 45 3325 1401
Fax
Email
s.sadrkabir@arums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Zahra Sadeghi
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Ataei ave.,
City
Ardabil
Postal code
Phone
+98 45 3325 1401
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)