Comparison of high-dose dual therapy and bismuth- containing quadruple therapy as a standard first line treatment in eradication of Helicobacter pylori infection
Comparison of high-dose dual therapy and bismuth- containing quadruple therapy as a standard first line treatment in eradication of Helicobacter pylori infection
Design
The clinical trial has two intervention groups, the selection of patients with H.pylori infection will be assigned Consecutive non-probability, and two intervention groups will be assigned randomly (using a table of random numbers)
Settings and conduct
the number of 206 patients referring to the gastroenterology clinic of Loqman Hospital during the mentioned period who are eligible to enter the study are divided into 2 groups, the first group is treated with four standard drugs containing bismuth and the second group is treated with high dose dual therapy for 14 days. After 4 weeks, the effectiveness of the mentioned two treatment methods is compared by the laboratory method of examining the antigen of H.pylori in stool.
Participants/Inclusion and exclusion criteria
In this study, patients who were diagnosed with H.pylori infection, are included in the study.
Patients are excluded from the study if they are pregnant or lactating and have an underlying disease that affects the study, as well as alcohol abuse, use of the mentioned drugs in the last 4 weeks.
Intervention groups
The first intervention group of patients receiving amoxicillin (1 gr 30 minutes after breakfast and dinner), pantoprazole (20 mg 30 minutes before breakfast and dinner), metronidazole (1 gr 30 minutes after breakfast and dinner), bismuth sub Citrate (240 mg 30 minutes before breakfast and dinner) for 14 days and
The second intervention group receiving high-dose dual treatment regimen including amoxicillin (1 gr 30 minutes after each meal) and pantoprazole (40 mg 30 minutes before breakfast and dinner) for 14 days, considering were taken
Main outcome variables
Eradication rate of H.pylori infection
General information
Reason for update
Acronym
نام اختصاری مهار کننده پمپ پروتون یا Proton Pump Inhibitors سه حرف PPI است.
IRCT registration information
IRCT registration number:IRCT20221016056190N1
Registration date:2023-01-15, 1401/10/25
Registration timing:retrospective
Last update:2023-01-15, 1401/10/25
Update count:0
Registration date
2023-01-15, 1401/10/25
Registrant information
Name
Maryam Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8827 9679
Email address
abasimaryam1989@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
2021-10-23, 1400/08/01
Actual recruitment end date
2022-03-16, 1400/12/25
Trial completion date
2022-03-16, 1400/12/25
Scientific title
Comparison of high-dose dual therapy and bismuth- containing quadruple therapy as a standard first line treatment in eradication of Helicobacter pylori infection
Public title
bismuth- containing quadruple and high-dose dual therapy in eradication of Helicobacter pylori infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic gastritis with or without improved PUD caused by Helicobacter pylori
Helicobacter pylori (+) determined by any of the rapid urease test and histopathology, urease breath test, fecal antigen test
Patients who have not received Helicobacter pylori eradication treatment
Exclusion criteria:
Allergy to the drugs used in the study
Use of PPIs, H2 receptor antagonists, antibiotics, bismuth or probiotics in the last 4 weeks before entering the study
Smoking and alcohol abuse
The presence of underlying disease or conditions such as liver disease, cardiovascular disease, lung disease, metabolic disease, or malignant tumor that may affect the study
Pregnant or lactating female patients
Performing esophageal or gastric surgery procedures in the past
Incomplete follow-up or low acceptance capacity of patients in treatment during the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
Actual sample size reached:
206
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of patients with Helicobacter pylori infection was done in a non-randomized manner and their division into two intervention groups was done randomly (using a table of random numbers) after considering confounding variables.In the table of random numbers, the direction of reading the table numbers was determined from the top and the left side, and then even numbers were considered for the intervention of the first group and odd numbers were considered for the intervention of the second group. And the second was specified.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
No.21 ,Valizadeh St, Gisha Ave, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1447973850
Approval date
2021-10-12, 1400/07/20
Ethics committee reference number
IR.SBMU.MSP.REC.1400.441
Health conditions studied
1
Description of health condition studied
Eradication of Helicobacter pylori infection
ICD-10 code
B98.0
ICD-10 code description
هلیکوباکتر پیلوری به عنوان عامل بیماری ها که در فصل های دیگر طبقه بندی می شود
Primary outcomes
1
Description
Eradication of Helicobacter pylori infection
Timepoint
4 weeks after receiving two treatment regimens, the eradication rate of Helicobacter pylori in two groups is compared
Method of measurement
Laboratory method of testing Helicobacter pylori antigen in stool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention group was treated with four standard medicines containing bismuth, including amoxicillin (1 gram 30 minutes after breakfast and dinner), pantoprazole (20 mg 30 minutes before breakfast and dinner), metronidazole (1 gram 30 minutes after breakfast and dinner), bismuth sub Citrate (240 mg 30 minutes before breakfast and dinner) is placed for 14 days.
Category
Treatment - Drugs
2
Description
Intervention group: The second intervention group is treated with two high-dose drugs including amoxicillin (1 gram 30 minutes after each meal including breakfast, lunch and dinner) and pantoprazole (40 mg 30 minutes before breakfast and dinner) for 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان لقمان حکیم
Full name of responsible person
shahriar nikpour
Street address
Kamali St
City
tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Fax
+98 21 5541 7547
Email
loghman.hospital@sbmu.ac.ir
Web page address
https://lhmc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
maryam abbasi
Street address
No21,valizadeh St,Gisha Ave
City
tehran
Province
Tehran
Postal code
1447973850
Phone
+98 21 8875 1818
Email
abasimaryam1989@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
does not have
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Abbasi
Position
Resident of internal medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Unit 9 , No 21, Valizadeh St, Gisha Ave ,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1447973850
Phone
+98 21 8827 9679
Fax
Email
Abasimaryam1989@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Abbasi
Position
Resident of internal medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Unit 9 , No 21, Valizadeh St, Gisha Ave ,Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1447973850
Phone
+98 21 8827 9679
Fax
Email
Abasimaryam1989@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
maryam abbasi
Position
resident of internal medicine
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No.21 , Valizadeh St, Gisha Ave, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1447973850
Phone
+98 81 3222 3198
Email
abasimaryam1989@yahoo.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
Undecided - It is not yet known if there will be 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
Study data related to the main outcome and side effects reviewed after de-identification of subjects can be shared with other researchers
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers of academic and scientific institutions
Under which criteria data/document could be used
The use of documentation and data analysis for other scientific research is allowed for other researchers
From where data/document is obtainable
By email to the following address
abasimaryam1989@yahoo.com
Maryam Abbasi
What processes are involved for a request to access data/document
After the request of the researchers, if at least 6 months have passed since the publication of the results, the data file will be sent after checking for use in the research