Comparison between the two drug regimens of "Amoxicillin-Rifaximin-PPI" and "Amoxicillin-Clarithromycin-PPI" for the treatment of H.pylory infection.
Design
Clinical trial with a control group and parallel groups, without blinding, without randomization, phase 4 on 86 patients.
Settings and conduct
86 patients with H. pylori infection who have not yet been treated to eradicate it, will be included in the study. Confirmation of H. pylori infection will be provided by rapid urease test or histological evaluation of antrum and gastric specimens by Giemsa staining.
Participants/Inclusion and exclusion criteria
Proof of H. pylori infection with rapid urease test or histological evaluation of gastric antrum and gastric body samples with Giemsa staining; patient's informed consent.
Intervention groups
Intervention group: A 14-day four-drug regimen containing rifaximin (rifaximin 500 mg, amoxicillin 1 g, Pantoprazole 40 mg and bismuth tablets, all twice a day)
Control group: Standard 14-day drug regimen (clarithromycin 500 mg, amoxicillin 1 g, pantoprazole 40 mg and bismuth tablets, all twice a day)
Main outcome variables
Eradication of H. pylori, evaluated by urine stool antigen test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230902059322N1
Registration date:2023-11-02, 1402/08/11
Registration timing:registered_while_recruiting
Last update:2023-11-02, 1402/08/11
Update count:0
Registration date
2023-11-02, 1402/08/11
Registrant information
Name
Zahra Vaez Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3551 4025
Email address
vaezmousavi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-06, 1402/06/15
Expected recruitment end date
2023-12-06, 1402/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the two drug regimens of "Amoxicillin-Rifaximin-PPI" and "Amoxicillin-Clarithromycin-PPI" for the treatment of H.pylory infection
Public title
Comparison between the two drug regimens for the treatment of H.pylory infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Proof of H. pylori infection by rapid urease test or histological evaluation of gastric antrum and corpus callosum samples by Giemsa staining
Informed consent of the patient
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
86
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committee of Tabriz University of Medical Sciences
Street address
University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2023-07-29, 1402/05/07
Ethics committee reference number
IR.TBZMED.REC.1402.374
Health conditions studied
1
Description of health condition studied
Helicobacter pylori [H. 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
Eradication of H. pylori, evaluated by urine stool antigen test
Timepoint
8 weeks after the end of treatment
Method of measurement
urine stool antigen test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A 14-day four-drug regimen containing rifaximin (rifaximin 500 mg, amoxicillin 1 g, Pantoprazole 40 mg and bismuth tablets, all twice a day)
Category
Treatment - Drugs
2
Description
Control group: Standard 14-day drug regimen (clarithromycin 500 mg, amoxicillin 1 g, pantoprazole 40 mg and bismuth tablets, all twice a day)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Seyed Yaghoob Moaddab
Street address
University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
vaezmousavi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi M.D.
Street address
Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 7054
Email
shahabip@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Vaez Mousavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 200, Novin AVE., Ghatran Blvd., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5173645481
Phone
+98 41 3551 4025
Fax
Email
vaezmousavi@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Vaez Mousavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 200, Novin AVE., Ghatran Blvd., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5173645481
Phone
+98 41 3551 4025
Fax
Email
vaezmousavi@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Vaez Mousavi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
No. 200, Novin AVE., Ghatran Blvd., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5173645481
Phone
+98 41 3551 4025
Fax
Email
vaezmousavi@tbzmed.ac.ir
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The study results will be published as an article. The
study protocol and statistical analysis used in the article
will be considered.
When the data will become available and for how long
It will be published a year after the study is completed
and will be available in the sources
To whom data/document is available
Information will be made available after permission of
the university for academic researchers and institutions
Under which criteria data/document could be used
Other researchers can use the results of the study in
their review and meta-analysis.
From where data/document is obtainable
Author: Seyede Zahra Vaez Mousavi
What processes are involved for a request to access data/document
Upon request, the corresponding author may respond