Evaluation of the role of Helicobacter pylori eradication in patients with non-alcoholic fatty liver disease on non-invasive criteria for liver fibrosis including FIB_4, NFS, BARD score
Determining the relationship between Helicobacter pylori eradication in patients with non-alcoholic fatty liver disease and FIB_4 NFS, BARD score
Design
Clinical trial without control group, without blinding, without randomization, phase 2 on 150 patients.
Settings and conduct
Patients with non-alcoholic fatty liver disease who referred to Tabriz Imam Reza Hospital clinic were selected based on the inclusion/exclusion criteria mentioned in other parts and with informed consent, Helicobacter pylori fecal antigen will be requested and if the antigen was positive We enter to the study and after obtaining sufficient information and relevant tests, the exact score of liver fibrosis is calculated based on the non-invasive criteria of liver fibrosis, and then Helicobacter pylori is eradicated with a 4-drug regimen, and again 6 months after the treatment, the exact score We calculate the non-invasive parameters of the liver and compare and check with the previous state.
Participants/Inclusion and exclusion criteria
1.Inclusion criteria: Patients with non-alcoholic fatty liver disease who are more than 18 years old and less than 65 years old
2. Exclusion criteria: alcoholics, under 18 years old, over 65 years old, people who have recently taken antibiotics or proton pump inhibitors, are excluded from the study.
Intervention groups
The intervention group includes patients with non-alcoholic fatty liver disease who receive Helicobacter pylori treatment intervention.
Main outcome variables
The NFS criterion ; The BARD score ; FIB-4 criteria
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230221057484N1
Registration date:2023-09-05, 1402/06/14
Registration timing:prospective
Last update:2023-09-05, 1402/06/14
Update count:0
Registration date
2023-09-05, 1402/06/14
Registrant information
Name
Mohammad Amin Gorbani Zirian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 2032
Email address
amin.gorbani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-21, 1402/06/30
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the role of Helicobacter pylori eradication in patients with non-alcoholic fatty liver disease on non-invasive criteria for liver fibrosis including FIB_4, NFS, BARD score
Public title
Evaluation of the role of Helicobacter pylori eradication in patients with non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with non-alcoholic fatty liver disease who are more than 18 years old and less than 65 years old
Patients whom despite full adherence to diet and lifestyle modification and appropriate physical activity for 6 months,There were no changes in the degree of fatty liver and liver enzymes and non-invasive measures of liver fibrosis
Exclusion criteria:
People who have a history of alcohol consumption
People who have recently taken antibiotics
People who have recently taken proton pump inhibitors
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of tabriz University of Medical Sciences
Street address
Faculty of Medicine, next to imam reza hospital . golgasht street
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-06-28, 1400/04/07
Ethics committee reference number
IR.TBZMED.REC.1401.291
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K75.8
ICD-10 code description
Other specified inflammatory liver diseases
Primary outcomes
1
Description
BARD score as a non-invasive criteria of liver fibrosis
Timepoint
The exact calculation of BARD score will be done two times (one time at the beginning, before the start of the intervention and the other 6 months after the eradication of Helicobacter pylori).
Method of measurement
calculation of score of non-invasive liver fibrosis criteria BARD score
2
Description
NFS score as a non-invasive criteria of liver fibrosis
Timepoint
The exact calculation of NFS will be done two times (one time at the beginning, before the start of the intervention and the other 6 months after the eradication of Helicobacter pylori).
Method of measurement
calculation of score of non-invasive liver fibrosis criteria NFS
3
Description
FIB_4 score as a non-invasive criteria of liver fibrosis
Timepoint
The exact calculation of FIB_4 will be done two times (one time at the beginning, before the start of the intervention and the other 6 months after the eradication of Helicobacter pylori).
Method of measurement
calculation of score of non-invasive liver fibrosis criteria FIB_4
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The People entered according to the entry and exit criteria, the level of body enzymes, the number of platelet, blood sugar were tested and with the help of age, height and weight, liver fibrosis scores (BARD score, NFS score, FIB-4) were determined and then will be treated with a four-drug regimen of Helicobacter pylori with metronidazole(Flagyl®) 400mg three times a day, bismuth(Bismuthan®) 220mg twice a day, amoxicillin(Amorax®) 1g three times a day and pentaprazole(Panzol®) 40mg once a day for 2 weeks and then 6 months After liver fibrosis scores (BARD score, NFS score, FIB-4) using body enzyme level tests, blood platelet count, blood sugar, age, height and weight will be calculated and compared with the previous score.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
mohammad amin gorbani zirian
Street address
Tabriz .Golgasht St. facing the central organization of Imam Reza Educational and Medical Center University
City
tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Fax
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir
Web page address
http://imamreza@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Daroush Savadi oskouei
Street address
Next to imam reza hospital,Golgasht sreet
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 6923
Fax
+98 41 3336 4659
Email
info.medfac@tbzmed.ac.ir
Web page address
http://medfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Amin Gorbani Zirian
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Next to imam reza hospital,Golgasht sreet
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 2032
Email
amin.gorbani77@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Amin Gorbani Zirian
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Next to imam reza hospital,Golgasht sreet
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 2032
Email
amin.gorbani77@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Amin Gorbani Zirian
Position
Medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Next to imam reza hospital,Golgasht sreet
City
tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3553 2032
Email
amin.gorbani77@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
When the data will become available and for how long
To whom data/document is available
Under which criteria data/document could be used
From where data/document is obtainable
What processes are involved for a request to access data/document