Effectiveness of Rosuvastatin ‐containing quadriple regimen in eradication of Helicobacter pylori infection compared to the standard four-drug regimen in Helicobacter pylori positive patients
Investigating the effectiveness of the quadruple diet along with rosuvastatin in eradicating Helicobacter pylori infection
Design
A clinical trial with a control group with double-blind parallel groups, randomized, phase 3 on 156 patients.
Settings and conduct
Patients referring to Taleghani Hospital will complete a questionnaire that includes demographic information, medical history and medication. H pylori infection will be evaluated by endoscopy or stool antigen. Patients are randomly divided into intervention and control groups. The primary endpoint of the study will be H pylori eradication and the secondary endpoint will be the incidence of treatment-related severe adverse events. Acceptable compliance to diet therapy is defined by taking at least 80% of prescribed drugs. After 4 weeks of treatment, all patients are re-evaluated. The incidence of side effects is determined as an evaluation of the safety of treatment regimens. After the end of the treatment period, the eradication rate of H pylori infection in the two groups and the frequency of side effects in the two groups will be determined and compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: confirmation of H. pylori infection in patients by standard diagnostic methods, age over 18 years. Exclusion criteria: history of gastric surgery, history of taking statins and antibiotics and non-steroidal and anti-inflammatory drugs, history of active gastrointestinal bleeding
Intervention groups
Intervention group: Patients in this group received rosuvastatin tablets (20 mg) once a day in addition to quadruple therapy (amoxicillin (1 g), clarithromycin (500 mg), metronidazole (500 mg) and omeprazole as a proton pump (40 mg). grams)) will receive for 1 month.
Control group: Patients in this group will consume the quadruple diet twice a day for 14 days.
Main outcome variables
H.pylori eradication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230314057717N2
Registration date:2023-06-21, 1402/03/31
Registration timing:prospective
Last update:2023-06-21, 1402/03/31
Update count:0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
Amir Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2540
Email address
amirsadaghi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Rosuvastatin ‐containing quadriple regimen in eradication of Helicobacter pylori infection compared to the standard four-drug regimen in Helicobacter pylori positive patients
Public title
The effect of the quadruple regimen containing rosuvastatin on the improvement of stomach infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of H. pylori infection in patients by standard diagnostic methods
Age above 18 years
Willingness to participate in the study
Exclusion criteria:
Patients are currently being treated with a four-drug regimen
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
156
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to two groups using the random block method. The number of blocks will be 22 and in each block, two, four or six patients will be included in the study order. Random allocation of blocks of patients to intervention and control treatment groups will be done through Sealed Envelope online software. The randomized list of blocks will be placed in sealed envelopes and will be provided to the gastroenterologist on a daily basis.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be blinded for patients, evaluator of drug outcomes and analysis. In this way, patients do not know in which group they are receiving medicine. Also, the evaluator does not know which patient has received which drug regimen during the examination of drug side effects and the rate of recovery of patients. Finally, the data is provided to the analyst in a coded form, and he does not know which data is related to which patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
4739-19395
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.SBMU.MSP.REC.1402.091
Health conditions studied
1
Description of health condition studied
Helicobacter pylori
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
Primary outcomes
1
Description
Helicobacter pylori eradication
Timepoint
Before the intervention and 14 days after the intervention
Method of measurement
Endoscopy or fecal antigen test
Secondary outcomes
1
Description
Occurrence of drug side effects
Timepoint
14 days after the start of the intervention
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Patients in this group received rosuvastatin tablets (20 mg) once a day in addition to quadruple therapy (amoxicillin (1 g), clarithromycin (500 mg), metronidazole (500 mg) and omeprazole as a proton pump (40 mg)). will receive for 1 month. The drug regimen will be provided to the patient in the form of a drug package.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will take a quadruple regimen including amoxicillin (1 g), clarithromycin (500 mg), metronidazole (500 mg) and omeprazole as a proton pump (40 mg) twice a day for 14 days. The drug regimen will be provided to the patient in the form of a drug package for a period of 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology and Liver Clinic, Taleghani Hospital
Full name of responsible person
Mohammad Javad Ehsani
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
4739-19395
Phone
+98 21 2303 1505
Email
info@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
4739-19395
Phone
+98 21 2243 9783
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shahrzad Salimi
Position
Rezident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
sharzad.salimi6969@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Sadeghi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2540
Email
amirsadeghimd@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Pardis Ketabimoghadam
Position
assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Arabi street, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 2525
Email
ketabimoghadam.p@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
Regarding the release of data, only data related to the consequences of taking drugs can be released.
Other patient information will not be reported
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Researchers, students and professors
Under which criteria data/document could be used
The data can be used if information is provided regarding the method of analysis, if the principle of referencing is observed
From where data/document is obtainable
Send an email to the corresponding author
Dr. Amir Sadeghi
Amirsadeghimd@yahoo.com
What processes are involved for a request to access data/document
Send the request to the responsible author via email and explain the details of the required data and mention the reason and how to use it