Protocol summary

Summary
Aim: assessment of any relationship between treatment of Helicobacter Pylori infection and improvement of fatty liver disease. inclusion criteria: patients with non-alcoholic fatty liver disease and Helicobacter Pylori infection. exclusion criteria: hypersensitivity to the prescribed drugs; non-consent to the participation to the study; study population: OPD patients attending in gastroenterology clinic, Velayat hospital; the sample size: 30; intervention: treatment of helicobacter pylori infection and assessment of its effect on improvement of of fatty liver disease; duration of the study: 6 months; outcome measures: liver function test, liver sonography.

General information

Acronym
role of treatment of HP in improvement of NAFLD
IRCT registration information
IRCT registration number: IRCT2015042020951N2
Registration date: 2015-05-12, 1394/02/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-05-12, 1394/02/22
Registrant information
Name
Amir Mohammad Kazemifar
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 6696
Email address
amkazemifar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research department of school of medicine; Qazvin university of medical sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of treatment of Helicobacter Pylori in improvement of non-alcoholic fatty liver disease
Public title
Role of Helicobacter Pylori in treatment of fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Helicobacter Pylori Infection according to serologic test; Non-alcoholic fatty liver disease according to liver function tests and sonography; consent to participation in the study. Exclusion criteria: presence of any other medical disease; history of hypersensitivity to the prescribed drugs; non-consent to the participation to the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of research department of Qazvin university of medical sciences
Street address
Bahonar Blvd, the University paradise
City
Qazvin
Postal code
Approval date
2015-01-07, 1393/10/17
Ethics committee reference number
28/20/9669

Health conditions studied

1

Description of health condition studied
Nonalcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified

2

Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters

Primary outcomes

1

Description
aspartate aminotransferase
Timepoint
at the start and end of the study
Method of measurement
by clinical labratory

2

Description
alanine aminotransferase
Timepoint
at the start and end of the study
Method of measurement
by clinical labratory

3

Description
sonographic indices of fatty liver disease
Timepoint
at the start and end of the study
Method of measurement
by a trained sonologist

Secondary outcomes

empty

Intervention groups

1

Description
Case group: treatment of Helicobacter Pylori with omeprazole (20 mg bid), amoxicilin (1gr bid), and clarithromycin (500 mg bid) orally for 2 weeks.
Category
Treatment - Drugs

2

Description
Control group: will receive only symptomatic therapy, if indicated; for example digestive tablet if complained from indigestion. Treatment of helicobacter pylori will be postponed until the end of the study (if the patients provide informed consent).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology clinic, Velayat hospital
Full name of responsible person
Elahe Hajinourmohammadi
Street address
Minoodar district
City
Qazvin

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
research department of medical college of QUMS
Full name of responsible person
Mahnaz Abbasi
Street address
Bahonar Blvd, the university paradise
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research department of medical college of QUMS
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
Qazvin University of Medica Sciences
Full name of responsible person
Elahe Hajinourmohammadi
Position
resident of internal medicine
Other areas of specialty/work
Street address
Buali hospital, Buali St.
City
Qazvin
Postal code
Phone
+98 28 3335 6696
Fax
Email
elahemehr@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Siences
Full name of responsible person
Aliakbar Hajaghamohammadi
Position
Gastroenterologist
Other areas of specialty/work
Street address
Velayat hospital, Minoodar District
City
Qazvin
Postal code
Phone
+98 28 3335 6696
Fax
Email
ahmohammadi@qums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Mohammad Kazemifar
Position
toxicologist
Other areas of specialty/work
Street address
Buali hospital, Buali St.
City
Qazvin
Postal code
Phone
+98 28 3335 6696
Fax
Email
amkazemifar@qums.ac.ir
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
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