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Comparison of efficacy and safety of quadruple regimens containing furazolidone in patients with Helicobacter pylori infection

Protocol summary

Study aim
Safety and efficacy of four-drug regimens containing furazolidone in H. pylori eradication
Design
Clinical trial work in the form of an intervention in which 135 patients who were randomly divided into three groups of 45 and treated with coded drug packages were divided into parallel and double-blind randomized phase 2 groups. Method: Simple randomization. Randomization unit: Individual. Randomization tool. Using the site http://www.randomizer.0rg
Settings and conduct
Adult patients referred to the endoscopy room clinic of Luqman Hakim Hospital with confirmed positive h. pylori infection are randomly divided into three therapeutic intervention groups that include regimens of 4 drugs containing furazolidone. The intervention groups are double-blind, and the drug packages are coded as Each intervention group is delivered and the effectiveness and safety of these regimens in eradication are examined
Participants/Inclusion and exclusion criteria
Entry conditions: H. pylori infection proven by standard diagnostic methods and age over seventeen years Conditions of non-entry: drug sensitivity to the studied diet, pregnancy, chronic diseases (kidney, liver, lung), patients treated with other antibiotics and probiotics, etc.
Intervention groups
It contains three experimental groups that are under the regimen of four drugs containing furazolidone First intervention group: furazolidone, proton pump inhibitor, bismuth, amoxicillin Second intervention group: furazolidone, proton pump inhibitor, bismuth, tetracycline The third intervention group: furazolidone, proton pump inhibitor, bismuth, levofloxacin
Main outcome variables
Drug side effects, eradication rate of H.pylori

General information

Reason for update
Acronym
no
IRCT registration information
IRCT registration number: IRCT20230202057305N1
Registration date: 2023-03-03, 1401/12/12
Registration timing: prospective

Last update: 2023-03-03, 1401/12/12
Update count: 0
Registration date
2023-03-03, 1401/12/12
Registrant information
Name
seide maryam moghadam ziabary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6690 6234
Email address
maryam.moghadam201@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-03, 1402/01/14
Expected recruitment end date
2023-06-04, 1402/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and safety of quadruple regimens containing furazolidone in patients with Helicobacter pylori infection
Public title
Investigating the effect of furazolidone drug for the treatment of stomach bacterial infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of H. pylori infection in patients by standard diagnostic methods Over seventeen years of age
Exclusion criteria:
History of known drug sensitivity to the studied drug regimen pregnancy Having chronic diseases (pulmonary, kidney, liver) Unwillingness to participate in the study Patients treated with other treatment methods such as probiotics, other antibiotics, etc.
Age
From 17 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 135
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple. Randomization unit: individual. Randomization tool: randomization using the site http://www.randomizer.0rg, which is extracted using random numbers obtained by the software, patients are divided into one of 3 groups: Amoxicillin A, Tetracycline T, and Levofloxacin L. In other words, We extract random numbers based on the number of samples introduced on the site
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients were randomly selected and placed in groups that were unaware of the other groups, and the medication package was delivered to them in coded form.
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 Medical School
Street address
Masal - Shahid Tabatabai St. - Stovar Alley - No. 5
City
Masal
Province
Guilan
Postal code
4381965747
Approval date
2023-02-22, 1401/12/03
Ethics committee reference number
IR.SBMU.MSP.REC.1401.589

Health conditions studied

1

Description of health condition studied
H. 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
Eradication and safety of drug regimens containing furazolidone in patients with H. pylori infection
Timepoint
Investigating the eradication rate of H. pylori two weeks after the end of the treatment regimen
Method of measurement
Standard diagnostic methods include RUT, histology staining, bacterial culture, antigen test

Secondary outcomes

1

Description
H. pylori eradication, drug safety
Timepoint
Two weeks after the end of the eradication treatment
Method of measurement
Urea breath test, fecal antigen, bacterial culture, histology

Intervention groups

1

Description
Intervention group: First intervention group: furazolidone, proton pump inhibitor, bismuth, amoxicillin. . which is in the form of furazolidone 100 every 12 hours, pentazol 40 every 12 hours, bismuth 240 every 12 hours, and amoxicillin 1000 every 12 hours and from Obeid Pharmaceutical Company for 10-14 days.
Category
Treatment - Drugs

2

Description
Intervention group: second intervention group: furazolidone, proton pump inhibitor, bismuth, tetracycline. Furazolidone 100 every 12 hours, pentazol 40 every 12 hours, bismuth 240 every 12 hours, tetracycline 500 every 6 hours. From Obeid Pharmaceutical Company for 10-14 days
Category
Treatment - Drugs

3

Description
Intervention group: The third intervention group: furazolidone, proton pump inhibitor, bismuth, levofloxacin in the form of furazolidone 100 every 12 hours, pentazol 40 every 12 hours, bismuth 240 every 12 hours, and levofloxacin 500 daily from Obeid Pharmaceutical Company for 10-14 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Loghman-e Hakim Hospital
Full name of responsible person
Seyedeh Maryam Moghadam Ziyabari
Street address
Tehteran Province, Tehran South Kargar St
City
Tehran
Province
Tehran
Postal code
1333625445
Phone
+98 21 5102 5182
Fax
+98 21 5541 6130
Email
Lcrdc@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti Faculty of Medicine, Shahid Arabi St., Student Blvd., Valenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Maryam Moghadam Ziabari
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Tabatabai St. - Stovar Alley - No. 5
City
Masal
Province
Guilan
Postal code
4381965747
Phone
+98 13 4468 2868
Email
maryam.moghadam201@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Maryam Moghadam Ziabri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Tabatabai St. - Stovar Alley - No. 5
City
Masal
Province
Guilan
Postal code
4381965747
Phone
+98 13 4468 2868
Email
maryam.moghadam201@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Maryam Moghadam Ziabri
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Tabatabai St. - Stovar Alley - No. 5
City
Masal
Province
Guilan
Postal code
4381965747
Phone
+98 13 4468 2868
Email
maryam.moghadam201@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared after de-identification
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
public
Under which criteria data/document could be used
Scientific and therapeutic research
From where data/document is obtainable
Send your request to maryam.moghadam201@gmail.com
What processes are involved for a request to access data/document
Just submit your request in email maryam.moghadam201@gmial.com
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