1. Home
  2. Approved trials
  3. » فارسی

The influence of probiotics and Zinc on the serum levels of liver enzymes and lipid profile in patients with non-alcoholic fatty liver disease

Protocol summary

Summary
The aim of this study is assess the influence of probiotics and Zinc on the serum levels of liver enzymes and lipid profile in patients with non-alcoholic fatty liver disease (NAFLD). This is a randomized, triple blind (blinding for patients, doctors and he who analyzed), controlled with placebo and single central study. In this study, 128 patients with NAFLD are studied.Inclusion criteria were Patients with NAFLD and exclusion criteria were autoimmune hepatitis, viral hepatitis, liver metabolic diseases, age below 18 and etc. Patients were randomly (randomized block design) divided into 4 groups of 32 people.The first group receive two probiotic capsules and two zinc capsules, the second group received two probiotic capsules and two zinc concentrate capsules, the third group received two capsules of probiotic placebo and two zinc capsules, and the fourth group received two probiotic capsules and two zinc plaques placebo capsules daily.The intervention time is 3 months. The serum level of ALT, AST, FBS, TG, Total cholesterol, TG, HDL and CRP, and weight, Waist and BMI are measured before and after the intervention, for each patient.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017080135408N1
Registration date: 2017-08-12, 1396/05/21
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-12, 1396/05/21
Registrant information
Name
Masoumeh Khedri
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 1839
Email address
khedri.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2016-12-05, 1395/09/15
Expected recruitment end date
2017-07-06, 1396/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The influence of probiotics and Zinc on the serum levels of liver enzymes and lipid profile in patients with non-alcoholic fatty liver disease
Public title
The influence of probiotics and Zinc on the patients with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with non-alcoholic fatty liver disease Exclusion criteria: autoimmune hepatitis- viral hepatitis- liver metabolic diseases- liver metabolic disease- drugs and toxins inception- age below 18- History of receiving medication for NAFLD- History of kidney or heart disease- Taking amiodarone, methotrexate, tamoxifen, glucocorticoids, sodium valproate and anti HIV drugs.
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 128
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
Ethics committee of Ahvaz Jundishpour University of Medical Sciences
Street address
Khuzestan, Ahvaz, Golestan, Ahvaz Jundishpour University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2016-10-22, 1395/08/01
Ethics committee reference number
IR.AJUMS.REC.1395.435

Health conditions studied

1

Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
K76.0

Primary outcomes

1

Description
ALT
Timepoint
Before and 3 months after intervention
Method of measurement
Blood test

2

Description
AST
Timepoint
Before and 3 months after intervention
Method of measurement
Blood test

3

Description
FBS
Timepoint
Before and 3 months after intervention
Method of measurement
Blood test

4

Description
Total cholesterol
Timepoint
Before and 3 months after intervention
Method of measurement
Blood test

5

Description
Triglyceride
Timepoint
Before and 3 months after intervention
Method of measurement
Blood test

6

Description
HDL
Timepoint
Before and 3 months after intervention
Method of measurement
Blood test

7

Description
LDL
Timepoint
Before and 3 months after intervention
Method of measurement
Blood test

8

Description
CRP
Timepoint
Before and 3 months after intervention
Method of measurement
Blood test

Secondary outcomes

1

Description
Weight
Timepoint
Before and 3 months after intervention
Method of measurement
Scale

2

Description
Body mass index (BMI)
Timepoint
Before and 3 months after intervention
Method of measurement
Body mass is expressed in units of kg/m2

3

Description
Waist
Timepoint
Before and 3 months after intervention
Method of measurement
Centimeter

Intervention groups

1

Description
Two protexin probiotic capsules 600 mg (Probiotics international, United Kingdom) and two zinc sulfate capsules 25 mg (Alhavi, Iran)are used daily, at noon and at night after meals, for three months. The protexin capsule contains 7 species of probiotics. Include Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium breve, Bifidobacterium longum and Lactobacillus bulgaricus.
Category
Treatment - Drugs

2

Description
Two protexin probiotic capsules 600 mg (Probiotics international, United Kingdom) and two zinc placebo capsules are used daily, at noon and at night after meals, for three months. The protexin capsule contains 7 species of probiotics. Include Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Lactobacillus acidophilus, Bifidobacterium breve, Bifidobacterium longum and Lactobacillus bulgaricus.
Category
Treatment - Other

3

Description
Two capsules of probiotic placebo and two zinc sulfate capsules 25 mg (Alhavi, Iran) are used daily, at noon and at night after meals, for three months.
Category
Treatment - Other

4

Description
Two probiotic placebo capsules and two zinc placebo capsules are used daily, at noon and at night after meals, for three months.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini Hospital
Full name of responsible person
Dr Masoumeh Khedri
Street address
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Center for Infectious Diseases of the Digestive System, Vice Chancellor research of Ahvaz J
Full name of responsible person
Dr Behzad Sharif Makhmalzadeh
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Center for Infectious Diseases of the Digestive System, Vice Chancellor research of Ahvaz J
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Masoumeh Khedri
Position
Hepatology and gastroenterology fellowship
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3221 6104
Fax
Email
khedri.m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Masoumeh Khedri
Position
Hepatology and gastroenterology fellowship
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3221 6104
Fax
+98 61 3222 5763
Email
khedri.m@ajums.ac.ir - khedrimasoumeh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr Masoumeh Khedri
Position
Hepatology and gastroenterology fellowship
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Phone
+98 61 3221 6104
Fax
+98 61 3222 5763
Email
khedri.m@ajums.ac.ir, khedrimasoumeh@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...