Considering the role of Helicobacter and the importance of eradication of this bacterium, we are finding a way to increase the success rate of Helicobacter pylori eradication compared to the existing standard treatment to reduce the complications of infection of this bacterium.
Design
A single-blind randomized clinical trial study
The 120 patients will be divided into two groups of 60 in the control group (receiving standard treatment) and the intervention group (receiving Atorvastatin in addition to standard treatment) based on a random number table.
Settings and conduct
Outpatient Clinic of Imam Khomeini Hospital
Patients are unaware of each other's treatment
The control group receiving standard treatment, the other group added Atorvastatin to standard treatment, and after 4 weeks of treatment, all patients would undergo assess fecal Helicobacter pylori antigens
Participants/Inclusion and exclusion criteria
Age >= 18 years
Absence of concurrent liver disease
Absence of concurrent diabetes
Not using statin in the past 6 months
No history of gastric surgery
No history of receiving H.pylori eradication therapy
No antibiotics, PPI, H2 blockers, anti-inflammatory drugs and NSAIDs, bismuth salts in the past month
No allergy to any of the antibiotics used in the study
Absence of gastrointestinal malignancy
No active gastrointestinal bleeding
Non-pregnant and non-lactating
No history of radiation therapy
Intervention groups
Standard treatment (a Bismuth Subcitrate 240 mg tablet, a Pantoprazole 40 mg tablet, a metronidazole 500mg tablet, and 2 amoxicillin 500mg capsules, all every 12 hours for 14 days) is prescribed for all patients and patients in the intervention group in addition to standard treatment with Atorvastatin 40mg daily for 14 days
Main outcome variables
Eradication of Helicobacter pylori
General information
Reason for update
Acronym
AHBPE
IRCT registration information
IRCT registration number:IRCT20190823044589N1
Registration date:2019-12-28, 1398/10/07
Registration timing:retrospective
Last update:2019-12-28, 1398/10/07
Update count:0
Registration date
2019-12-28, 1398/10/07
Registrant information
Name
Parham Porteghali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3198 8002
Email address
parham.porteghali@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of adding Atorvastatin to standard treatment in Helicobacter pylori eradication
Public title
Effect of Atorvastatin in Helicobacter pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 years or older
Indication for Helicobacter pylori eradication
Exclusion criteria:
liver disease at the same time
Diabetes at the same time
Statin use in 6 months
History of gastric surgery
History of treatment for eradication of H. pylori
Antibiotics, PPIs, histamine receptor blockers, anti-inflammatory and non-steroidal drugs, bismuth salts in the past month
Allergy to any of the antibiotics used in the study
Gastrointestinal malignancy
Active gastrointestinal bleeding
Pregnant and lactating
History of radiation therapy
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly based on random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients don't know medications other patients receive for treatment
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
West Azarbaijan University of Medical Sciences and Health services, next to emergency department, Jahad St., Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2019-07-31, 1398/05/09
Ethics committee reference number
IR.UMSU.REC.1398186
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Helicobacter pylori eradication
Timepoint
After 4 weeks of completion of treatment
Method of measurement
38/5000Evaluation of Helicobacter pylori fecal antigen
Secondary outcomes
1
Description
Drug Side effects
Timepoint
During and after the course of treatment
Method of measurement
Ask the patient
Intervention groups
1
Description
Intervention group: Atrostatin 40 mg at night for 14 days with standard treatment (including a Bismuth Subcitrate 240 mg tablet, a Pantoprazole 40 mg tablet, a metronidazole 500 mg tablet, and 2 x amoxicillin 500 mg capsules, all every 12 hours for 14 days)
Category
Treatment - Drugs
2
Description
Control group: Standard treatment for 14 days (including a Bismuth Subcitrate 240 mg tablet, a Pantoprazole 40 mg tablet, a metronidazole 500 mg tablet, and 2 x amoxicillin 500 mg capsules, all every 12 hours for 14 days)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Reza Mohammad Hosseini Azar
Street address
Imam Khomeini Hospital, Ershad Street
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Fax
Email
emam-h-urm@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
West Azarbaijan University of Medical Sciences and Health services, next to emergency department, Jahad St., Resalat Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Reza Mohammad Hosseini Azar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
gastroenterology and hepatology
Street address
Imam Khomeini Hospital, Ershad Street
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Email
mohammadazar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Reza Mohammad Hosseini Azar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
gastroenterology and hepatology
Street address
Imam Khomeini Hospital, Ershad Street
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Email
mohammadazar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Parham Porteghali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Ershad Street
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
Email
parham.porteghali@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All underlying information, grouping and the result of treatment of patients without mentioning the name of the patient in Excel and SPSS files are recorded and presented.
When the data will become available and for how long
6 months after the article to be published
To whom data/document is available
All academic and non-academic person
Under which criteria data/document could be used
In order to request the results and outputs of data analysis in the SPSS software, after submitting the application and approval of Urmia University of Medical Sciences, statistical outputs will be provided.
From where data/document is obtainable
Vice chancellor for research and technology of Urmia University of Medical Sciences
What processes are involved for a request to access data/document
After submitting the application and approval of the Deputy of research and Technology of Urmia University of Medical Sciences, the results will be sent during the maximum one month period by researcher.