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Comparison of three therapeutic regimens (Rabiprazole, Amoxicillin, Bismuth subcetate, Clarithromycin (1), Rabiprazole, Amoxicillin, Clarithromycin (2) Rabiprazole, Amoxicillin, Bismuth subcetate, Furazolidone (3)) in eradication of Helicobacter pylori in

Protocol summary

Study aim
The objective of this open-label randomized clinical trial is compare of three therapeutic regimens (Rabiprazole, Amoxicillin, Bismuth subcitrate, Clarithromycin (A), Rabiprazole, Amoxicillin, Clarithromycin (B), Rabiprazole, Amoxicillin, Bismuth subcetate, Furazolidone (C)) in eradication of Helicobacter pylori in patients with dyspepsia. In this study, the effect of adding Bismuth subcitrate to the treatment regimen of Clarithromycin, Amoxicillin and Rabiprazole will also be evaluated.
Design
In this research, 90 patients with dyspepsia and Helicobacter pylori infection will be included in the study. Inclusion criteria is endoscopic and biopsied patients; report of the Helicobacter pylori organism in the tissue sample. Exclusion criteria is pregnancy; intolerance to drugs; interaction with medications such as digoxin; drug complications during treatment. The subjects will randomly divided into three groups and each group is randomly treated with one of the three therapeutic regimens.
Settings and conduct
In this open-label randomized clinical trial, 90 patients with dyspepsia and Helicobacter pylori infection will be included in the study. The subjects will randomly divided into three groups and each group is randomly treated with one of the three therapeutic regimens. Intervention will be done in three groups: Rabiprazole for 6 weeks, Amoxicillin, Bismuth subcitrate and Clarithromycin for 2 weeks (A), Rabiprazole for 6 week, Amoxicillin and Clarithromycin for 2 weeks (B), Rabiprazole for 6 weeks, Amoxicillin, Bismuth subcetate and Furazolidone for 2 weeks (C). Demographic information, history of smoking, alcohol consumption, previous upper gastrointestinal bleeding, inflammation of the tissue in the pathology report and endoscopic findings will recorded questionnaires. The fecal antigen of the Helicobacter pylori will checked four weeks after the end of the treatment. Then the collected data will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria is endoscopic and biopsied patients; report of the Helicobacter pylori organism in the tissue sample.
Intervention groups
Intervention will be done in three groups: Rabiprazole for 6 weeks, Amoxicillin, Bismuth subcitrate and Clarithromycin for 2 weeks (A), Rabiprazole for 6 week, Amoxicillin and Clarithromycin for 2 weeks (B), Rabiprazole for 6 weeks, Amoxicillin, Bismuth subcetate and Furazolidone for 2 weeks (C).
Main outcome variables
The fecal antigen of the Helicobacter pylori will checked four weeks after the end of the treatment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160318027097N6
Registration date: 2017-12-12, 1396/09/21
Registration timing: prospective

Last update: 2017-12-12, 1396/09/21
Update count: 0
Registration date
2017-12-12, 1396/09/21
Registrant information
Name
ِDr Faramarz Darghahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2000
Email address
mj.naghizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ardebil University of Medical Sciences
Expected recruitment start date
2017-12-16, 1396/09/25
Expected recruitment end date
2018-03-16, 1396/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three therapeutic regimens (Rabiprazole, Amoxicillin, Bismuth subcetate, Clarithromycin (1), Rabiprazole, Amoxicillin, Clarithromycin (2) Rabiprazole, Amoxicillin, Bismuth subcetate, Furazolidone (3)) in eradication of Helicobacter pylori in
Public title
Treatment of Helicobacter Pylori infection in patients with dyspepsia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Endoscopic and biopsied patients; Report of the Helicobacter pylori organism in the tissue sample.
Exclusion criteria:
Pregnancy; Intolerance to drugs; Interaction with medications such as digoxin; drug complications during treatment.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is block, individual and using a random number table in this study. 90 numbers will entered the random block and numbers are randomly assigned into three groups. Accordingly, the patients will receive one of three regimens with their randomly assigned number. In this study, participants, researchers are unaware of prescription drugs.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
90 numbers will enter the random block, and randomly the numbers are divided into three groups. Accordingly, patients will receive one of three regimens with their randomly pre-assigned number.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ardebil University of Medical Sciences
Street address
Ardebil University of Medical Sciences, daneshghah ave, Ardebil, Iran
City
Ardebil
Province
Ardabil
Postal code
5163639888
Approval date
2017-07-24, 1396/05/02
Ethics committee reference number
IR.ARUMS.REC.1396.85

Health conditions studied

1

Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Dyspepsia

Primary outcomes

1

Description
fecal antigen of Helicobacter pylori
Timepoint
4 weeks after Intervention
Method of measurement
ELISA

Secondary outcomes

empty

Intervention groups

1

Description
Case group (2): Rabiprazole, Tablet 40mg oral OD for 6 weeks. Amoxicillin, Tablet 1000mg oral BD for 2 weeks. Clarithromycin, Tablet 500mg oral BD for 2 weeks
Category
Treatment - Drugs

2

Description
Case group (3): Rabiprazole, Tablet 40mg oral OD for 6 weeks. Amoxicillin, Tablet 1000mg oral BD for 2 weeks. Bismuth subcitrate, Tablet 120mg oral BD for 2 weeks. Furazolidone Tablet 200mg oral BD for 2 weeks
Category
Treatment - Drugs

3

Description
Case group (1): Rabiprazole, Tablet 40mg oral OD for 6 weeks. Amoxicillin, Tablet 1000mg oral BD for 2 weeks. Bismuth subcitrate, Tablet 120mg oral BD for 2 weeks. Clarithromycin Tablet 500mg oral BD for 2 weeks
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vice Chancellor for research of Ardebil University of Medical Sciences
Full name of responsible person
Dr Shahram Habibzadeh
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2000
Email
Sh.habibzadeh@arums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Ardebil University of Medical Sciences
Full name of responsible person
Dr Shahram Habibzadeh
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardebil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2000
Email
Sh.habibzadeh@arums.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Ardebil 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
Ardebil University of Medical Sciences
Full name of responsible person
Dr Masoud Tasoji
Position
Internal Medicine Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardebil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Fax
Email
naghizadeh73@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr Mohammad Sadrkabir
Position
Gastroenterologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardebil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Fax
Email
M.sadrkabir@arums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardebil University of Medical Sciences
Full name of responsible person
Dr Masoud Tasoji
Position
Internal Medicine Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardebil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Fax
Email
naghizadeh73@yahoo.com
Web page address

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
Total potential data after unidentifiable individuals
When the data will become available and for how long
Start the access period from 2019
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
Data can be used for scientific and research studies.
From where data/document is obtainable
Dr Masoud Tasoji; Internal Medicine Assistant; M.tasoji@arums.ac.ir
What processes are involved for a request to access data/document
After receiving the request email, data files will be sent in less than a week.
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