Determining the effect of coamoxiclav-based two-drug treatment on eradication of Helicobacter pylori
Design
The present study is a randomized clinical trial without blinding that will be performed in patients referred to Imam Khomeini Hospital in Urmia and will be randomly divided into two groups using Random allocation computer software.
Settings and conduct
Patients referred to Imam Khomeini Hospital in Urmia who have been diagnosed with Helicobacter pylori infection by a positive pathology or serological test will be included in the study. Patients in the treatment of side effects and drug tolerance by telephone follow-up and all cases are recorded. Two weeks after the end of treatment, the patient will have a urease breath test and if the test is positive, the respiratory test will be registered as a treatment failure and if the test is negative, it will be registered as a successful eradication of Helicobacter pylori.
Participants/Inclusion and exclusion criteria
Age over 18 years
Helicobacter pylori serology test is positive
Severe disorders affecting the gastrointestinal tract
No malignancy of the gastrointestinal tract
Non-pregnant and non-lactating
No history of radiation therapy
No allergies to any of the antibiotics used in the study
No active gastrointestinal bleeding
Intervention groups
The two-drug regimen consists of amoxicillin 500 mg twice daily with coamoxiclav 625 mg twice daily and rabizol four times daily for two weeks, after that, antibiotics are discontinued and rabizol alone is administered for two weeks later.
The standard regimen includes amoxicillin 1000 mg twice daily, bismuth twice daily, metronidazole 500 mg twice daily, and pantoprazole twice daily for two weeks. The drugs are then discontinued and pantoprazole is continued for two weeks.
Main outcome variables
Eradication of Helicobacter pylori
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201213049694N1
Registration date:2020-12-15, 1399/09/25
Registration timing:registered_while_recruiting
Last update:2020-12-15, 1399/09/25
Update count:0
Registration date
2020-12-15, 1399/09/25
Registrant information
Name
Arezoo Delshad Sisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3198 8002
Email address
arezoo.delshad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-02-18, 1399/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of dual drug therapy effect with coamoxiclav-based on Helicobacter pylori eradication
Public title
Effect of dual drug therapy with coamoxiclav-based on Helicobacter pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Helicobacter pylori serology test is positive
Severe disorders affecting the gastrointestinal tract
Exclusion criteria:
Gastrointestinal malignancy
Pregnant and lactating
History of radiotherapy
Allergy to any of the antibiotics used in the study
Active gastrointestinal bleeding
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
188
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomly using computer software Random allocation into two groups of 94 patients treated with amoxicillin-based two-drug regimen coamoxiclav-based and quadruple regimen will be standard.
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 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
2020-09-30, 1399/07/09
Ethics committee reference number
IR.UMSU.REC.1399.262
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection
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
After 2weeks of completion of treatment
Method of measurement
Urea breath test
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: The two-drug regimen consists of amoxicillin 500 mg twice daily with coamoxiclav 625 mg twice daily and rabizol four times daily for two weeks, after that, antibiotics are discontinued and rabizol alone is administered for two weeks later
Category
Treatment - Drugs
2
Description
Control group: Control group: Standard regimen includes amoxicillin 1000 mg twice daily, bismuth twice daily, metronidazole 500 mg twice daily and pantoprazole twice daily for two weeks. The drugs are then discontinued and pantoprazole is continued for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Mohammad Reza Pashaei
Street address
Imam Khomeini Hospital, Ershad Street
City
Urmia
Province
West Azarbaijan
Postal code
5715781351
Phone
+98 44 3346 9931
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 Pashaei
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
dr.pashaei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Mohammad Reza Pashaei
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
dr.pashaei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Arezoo Delshad Sisi
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
arezoo.delshad@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.