Comparison of three-drug and consecutive treatment regimens in the eradication of Helicobacter pylori in patients referred to the gastrointestinal clinic of Imam Khomeini Hospital in Urmia
Comparison of three-drug and consecutive treatment regimens in the eradication of Helicobacter pylori in patients referred to the gastrointestinal clinic of Imam Khomeini Hospital in Urmia
Design
On 270 patients (in groups of 90 people)
Settings and conduct
Gastroenterology Clinic of Imam Khomeini Hospital in Urmia
Participants/Inclusion and exclusion criteria
Inclusion criteria 1- Endoscopically confirmed primary Helicobacter pylori infection 2- Having dyspepsia for at least 6 months or more 3- No history of taking any antibiotics during the last month and no history of taking proton pump inhibitors And antacids in a recent month and exclusion criteria: 1- Upper gastrointestinal surgery, gastric cancer, kidney and liver failure 2- Pregnancy and lactation 3- Age under 18 4- Allergy to the studied drugs 5- Alcohol consumption in patients 6- Patients receiving antiarrhythmic drugs
Intervention groups
Group 1: omeprazole 20mg twice daily + amoxicillin 1 g twice daily + clarithromycin 500mg twice daily for 10 days
Group 2: omeprazole 20mg twice daily + amoxicillin 1 g daily for 2 weeks + levofloxacin 500mg twice daily in the first week of the diet
Group 3: omeprazole 20mg twice daily + amoxicillin one gram twice daily for 5 days + metronidazole 500mg twice daily for the second 5 days + clarithromycin 500mg twice daily for the second 5 days that (these drugs are routine drugs It was used to treat patients. Then, after the end of treatment, patients were evaluated for side effects of drugs. Patients went to the clinic 2 weeks, 6 weeks and 10 weeks after starting treatment.
Main outcome variables
Reduce complications and improve the condition of the disease
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200907048643N1
Registration date:2020-09-14, 1399/06/24
Registration timing:retrospective
Last update:2020-09-14, 1399/06/24
Update count:0
Registration date
2020-09-14, 1399/06/24
Registrant information
Name
Omid garkaz
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3232 5054
Email address
omid.garkaz23@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2019-03-20, 1397/12/29
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-03-20, 1397/12/29
Scientific title
Comparison of three-drug and consecutive treatment regimens in the eradication of Helicobacter pylori in patients referred to the gastrointestinal clinic of Imam Khomeini Hospital in Urmia
Public title
Comparison of three-drug and consecutive treatment regimens in the eradication of Helicobacter pylori in patients referred to the gastrointestinal clinic of Imam Khomeini Hospital in Urmia
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
1- Endoscopic primary infection of Helicobacter pylori
2-Have symptoms of dyspepsia for at least 6 months or more
3- No history of taking any antibiotics during the last month and no history of taking proton and antacid pump inhibitors in the last month
Exclusion criteria:
1- Endoscopic primary infection of Helicobacter pylori
2-Have symptoms of dyspepsia for at least 6 months or more
3- No history of taking any antibiotics during the last month and no history of taking proton and antacid pump inhibitors in the last month
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
270
Actual sample size reached:
270
Randomization (investigator's opinion)
Randomized
Randomization description
Gastrointestinal patients were selected after entering the gastrointestinal clinic and were randomly divided into three groups. A total of 270 patients were selected in groups of 90 with three, The groups were divided into each of which was randomly given one of the drug groups.The tool for making random blocks was https://www.sealedenvelope.com.
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
Urmia University of Medical Sciences
Street address
Resalat Street, next to the provincial emergency room
City
Urima
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
IR.UMSU.REC.1397.239
Health conditions studied
1
Description of health condition studied
Comparison of three-drug and consecutive treatment regimens in eradication of Helicobacter pylori in patients referred to the gastrointestinal clinic of Imam Khomeini Hospital in Urmia
ICD-10 code
K20
ICD-10 code description
Oesophagitis
Primary outcomes
1
Description
Helicobacter pylori treatment
Timepoint
Patients were referred to the clinic 2 weeks, 6 weeks and 10 weeks after starting treatment. Patients were examined for Helicobacter pylori by Stool Ag test. Individuals who were registered for successful negative test treatment for H. pylori eradication. In the second week visit, all side effects including (bad taste, dry mouth, diarrhea, confusion, tongue burn, nausea and vomiting, abdominal pain, constipation and headache) and patient compliance were recorded based on the number of pills remaining and then four weeks PPI only It was taken and then they did not take any PPI and antibiotics for 4 weeks and then it was proved by Stool Ag eradication of Helicobacter pylori infection in each group.
Method of measurement
Blood and stool tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First group: omeprazole 20mg twice daily + amoxicillin one gram twice daily + clarithromycin 500mg twice daily for 10 days Second group: omeprazole 20mg twice daily + amoxicillin one gram daily for 2 weeks + levofloxacin 500mg Twice a day in the first week of the diet and the third group: omeprazole 20mg twice daily + amoxicillin one gram twice daily for 5 days + metronidazole 500mg twice daily for the second 5 days + clarithromycin 500mg twice daily for 5 second day
Category
Treatment - Drugs
2
Description
Intervention group: Group 2: omeprazole 20mg twice daily + amoxicillin 1 g daily for 2 weeks + levofloxacin 500mg twice daily in the first week of the diet
Category
Treatment - Drugs
3
Description
Intervention group: Group 3: omeprazole 20mg twice daily + amoxicillin one gram twice daily for 5 days + metronidazole 500mg twice daily for the second 5 days + clarithromycin 500mg twice daily for the second 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterology Clinic of Imam Khomeini Hospital, Urmia, with indication for eradication of Helicob
Full name of responsible person
Hamid Reza Mehryar
Street address
Resalat Steret
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
omid.garkaz23@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
Streat Resalt
City
Urima
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
omid.garkaz23@gmail.com
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
1
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
Hamid Reza Mehryar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Streat Resalt
City
Urima
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
omid.garkaz23@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hamid Reza Mehryar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Resalt Streat
City
Urima
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
Hamidrezamehryar2010@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Hamid Reza Mehryar
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Resalat Street
City
Urima
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
Hamidrezamehryar2010@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
No - There is not 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
It is about the best treatment.
When the data will become available and for how long
Always
To whom data/document is available
Researcher
Under which criteria data/document could be used
Always
From where data/document is obtainable
Patients referred to the gastrointestinal clinic
What processes are involved for a request to access data/document