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Multicenter, Randomized, Allocation-Concealed, Assessor-Blinded Trial of Three H. pylori Eradication Regimens in Iranian Patients

Protocol summary

Study aim
To compare the clinical effectiveness of three Helicobacter pylori eradication regimens in Iranian adults
Design
Multicenter, Randomized, Allocation-Concealed, Assessor-Blinded Trial of Three H. pylori Eradication Regimens in 1230 Iranian Patients
Settings and conduct
Patients with H.pylori infection who visit one of the 13 study centers during the study will receive (if eligible)treatment packages according to a random code assigned by the website
Participants/Inclusion and exclusion criteria
Inclusion criteria: Adult patients with Indications for H. pylori treatment Exclusion criteria: Previous treatment, Use of Antibiotics or bismuth 4 weeks or PPIs 2 weeks prior, Gastric surgery, Cancer or severe systemic disease, Known Allergy, Pregnancy or lactation
Intervention groups
Intervention Group 1: The optimized bismuth quadruple regimen for 14 days: 1- Esomeprazole (Ezonium, Abidi Pharmaceutical) 20 mg one capsule every 12 hours, 2- Bismuth subcitrate (Alborz Darou) 120 mg one tablet every 6 hours, 3- Tetracycline (Iran Darou) 250 mg two capsules every 6 hours, 4- Metronidazole (Cosar Pharmaceutical) 500 mg one tablet every 6 hours Intervention Group 2 :PCAB based dual regimen for 14 consecutive days:1- Vonoprazan (PHORIZE, Abide Pharmaceutical) 20 mg one tablet every 12 hours, 2-Amoxicillin (Cosar Pharmaceutical) 500 mg two tablets every 8 hours Intervention group 3 : The modified bismuth quadruple regimen for 14 days: 1- Esomeprazole (Ezonium, Abidi Pharmaceutical) 40 mg one capsule every 12 hours, 2- Bismuth subcitrate (Alborz Darou) 120 mg two tablets every 12 hours, 3- Amoxicillin (Cosar Pharmaceutical) 500 mg two tablets every 12 hours, 4- Metronidazole (Cosar Pharmaceutical) 500 mg one tablet every 12 hours
Main outcome variables
Primary outcome: eradication of Helicobacter pylori, defined as negative stool antigen six weeks after completion of treatment

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200128046294N4
Registration date: 2025-10-26, 1404/08/04
Registration timing: prospective

Last update: 2025-10-26, 1404/08/04
Update count: 0
Registration date
2025-10-26, 1404/08/04
Registrant information
Name
Anahita Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8241 5104
Email address
a-sadeghi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-06, 1404/08/15
Expected recruitment end date
2026-04-19, 1405/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Multicenter, Randomized, Allocation-Concealed, Assessor-Blinded Trial of Three H. pylori Eradication Regimens in Iranian Patients
Public title
Clinical trial for Helicobacter pylori eradication regimens
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients(18–60 years old) Indication of H.pylori treatment (Peptic ulcer disease, Marginal zone B-cell lymphoma MALT type, Uninvestigated dyspepsia in patients who are under the age of 60 years, Functional dyspepsia, Adult household members of individuals who have a positive non-serological test for H. pylori, Patients taking long term NSAIDs or starting long-term treatment with aspirin, Patients with unexplained iron deficiency anemia, Patients with idiopathic autoimmune thrombocytopenic purpura, Primary and secondary prevention of gastric adenocarcinoma, Current or history of gastric premalignant conditions, Persons with a first degree relative with gastric cancer, Syndromes associated with an increased risk for gastric cancer, Patients with autoimmune gastritis) Informed consent for participating in the study
Exclusion criteria:
Prior eradication of h.pylori Taking antibiotics, or bismuth-containing medications within four weeks and proton pump inhibitors (PPIs) within two weeks prior to study entry History of gastric surgery Cancer or severe systemic disease Known sensitivity to drugs used in the treatment protocol Pregnancy breastfeeding
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 1230
Randomization (investigator's opinion)
Randomized
Randomization description
An online system (site) will be designed for this study and implemented on the servers of the Gastroenterology and Liver Research Institute. After reviewing the entry criteria and obtaining informed consent, this system will include patient information and assigning drug package codes. Each physician participating in this project can log in to the site using his or her own code and enter patient information. This system will automatically notify the physician of the specific package number for each patient only after the final registration of the first form of the patient questionnaire. Patients will be assigned to three treatment regimens in a ratio of 1:1:1 and based on a randomized block method with a block size of 6. The randomization of this study will be designed using R software by an individual independent of the executive team. The generated random sequence will be stored centrally and secretly at the central study site. All medications will be prepared in sealed and coded packages and delivered to the centers. These packages are standardized in terms of appearance, size, color, and shape so that there is no distinction between the packages. In the allocation process, the doctor only receives the package number from the system and delivers the package to the patient without knowing the contents inside. In each package, the method of taking the drugs in the package will be fully mentioned along with the necessary explanations and possible side effects of the drugs. Also, contact numbers will be provided for the patients of the plan to communicate with the treating physician and the central study and consultation team regarding the drugs and their side effects.
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 Digestive Disease Research Institute - Tehran University of Medical Sciences
Street address
Digestive Disease Research Institute, Shariati Hospital, Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2025-09-16, 1404/06/25
Ethics committee reference number
IR.TUMS.DDRI.REC.1404.014

Health conditions studied

1

Description of health condition studied
Helicobacter pylori
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters

Primary outcomes

1

Description
Eradication of Helicobacter pylori infection
Timepoint
Time of positive Helicobacter pylori test at the beginning of treatment and eradication test six weeks after completion of the fourteen day treatment period
Method of measurement
Negative H. pylori antigen in stool antigen test or negative Urea breath test

Secondary outcomes

1

Description
Percentage of patients experiencing at least one adverse event during the study
Timepoint
Six weeks after completing the fourteen-day drug treatment
Method of measurement
Structured clinical interview and completion of an adverse event report form with physician

2

Description
Percentage of adherence to each medication
Timepoint
6 weeks after completion of treatment at the final visit
Method of measurement
The patient hands over all of his or her medications during the final visit, and the number of each medication the patient has taken will be recorded on the website.

Intervention groups

1

Description
Intervention Group 1: The optimized bismuth quadruple regimen for 14 days: 1- Esomeprazole (Ezonium, manufactured by Abidi Pharmaceutical Company), 20 mg, one capsule every 12 hours 2- Bismuth subcitrate (manufactured by Alborz Darou Company), 120 mg, one tablet every 6 hours 3- Tetracycline (manufactured by Iran Darou Company), 250 mg, two capsules every 6 hours 4- Metronidazole (manufactured by Cosar Pharmaceutical Company), 500 mg, one tablet every 6 hours
Category
Treatment - Drugs

2

Description
Intervention Group 2 :Potassium-competitive acid blocker (PCAB)-based dual regimen for 14 consecutive days:1- Vonoprazan (PHORIZE, manufactured by Abide Pharmaceutical Co.), 20 mg, one tablet every 12 hours 2-Amoxicillin (manufactured by Cosar Pharmaceutical Co.), 500 mg, two tablets every 8 hours
Category
Treatment - Drugs

3

Description
Intervention group 3 : The modified bismuth quadruple regimen for 14 days: 1- Esomeprazole (Ezonium, produced by Abidi Pharmaceutical Company), 40 mg, one capsule every 12 hours 2- Bismuth subcitrate (produced by Alborz Darou Company), 120 mg, two tablets every 12 hours 3- Amoxicillin (produced by Cosar Pharmaceutical Company), 500 mg, two tablets every 12 hours 4- Metronidazole (produced by Cosar Pharmaceutical Company), 500 mg, one tablet every 12 hours
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr Anahita Sadeghi
Street address
Shariati Hospital, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5000
Fax
+98 21 8241 5400
Email
a-sadeghi@tums.ac.ir
Web page address
http://shariati.tums.ac.ir/

2

Recruitment center
Name of recruitment center
Research Institute for Gastroenterology and Liver Diseases Shahid Beheshti University of Medical Sci
Full name of responsible person
Saeed Abdi
Street address
Gastroenterology and Hepatology Research Institute, Taleghani Hospital, Erabi Street, Yemen Street, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 21 2303 1678
Email
Saeedabdi75@yahoo.com

3

Recruitment center
Name of recruitment center
Private office
Full name of responsible person
Maryam Soheilipour
Street address
2nd Unit, Nikan Complex, 3rd Alley, Next to Ayandeh Bank, East Shariati St, Upper Chaharbagh St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8173734163
Phone
+98 31 3628 5295
Email
m_soheilip@yahoo.com

4

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Farhad Zamani
Street address
Firoozgar Hospital, Behafarin Street, Valiasr Square,
City
Tehran
Province
Tehran
Postal code
1593748711
Phone
+98 21 8214 1574
Email
zamani.farhad@gmail.com

5

Recruitment center
Name of recruitment center
Rasoul akram hospital
Full name of responsible person
Shahram agah
Street address
Colorectal research center, Rasoul Akram Hospital, Sattarkhan Street, Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 919 952 9650
Email
Shahramagah@gmail.com

6

Recruitment center
Name of recruitment center
Mashhad University Medical Sciences
Full name of responsible person
Mitra Ahadi
Street address
Dr. Mitra Ahadi’s Office, No. 404, Faraz Medical Building, Koohsangi 9, Koohsangi Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9185656398
Phone
+98 51 3840 2364
Email
ahadim@mums.ac.ir

7

Recruitment center
Name of recruitment center
Masoud clinic
Full name of responsible person
Reza Malekzadeh
Street address
No. 114, 19th Alley, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1439963553
Phone
+98 21 5453 4000
Email
malek@tums.ac.ir

8

Recruitment center
Name of recruitment center
Doctor Moosavy clinic
Full name of responsible person
Seyed Hamid Moosavy
Street address
No. 207, Arzhin Building, Seyed Jamal Aldin Asadabadi Boulevard, Bandarabbas
City
Bandarabbas
Province
Hormozgan
Postal code
7914690066
Phone
+98 76 3338 0791
Email
Seyedhamidmoosavy@outlook.com

9

Recruitment center
Name of recruitment center
Namazi Hospital
Full name of responsible person
Samira Saeian
Street address
Namazi Hospital, Zand Blvd , Namazi Sq, Shiraz
City
Shiraz
Province
Fars
Postal code
7193613311
Phone
+98 71 6474 3160
Email
samira_saeian@yahoo.com

10

Recruitment center
Name of recruitment center
Sheikh Al Rais clinic
Full name of responsible person
Amin Sadrazar
Street address
Sheikh Al Rais Clinic, Parsa Street, Azadi Boulevard, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3380 4486
Email
dr.sadrazar@gmail.com

11

Recruitment center
Name of recruitment center
Medical office - Iradj Maleki MD
Full name of responsible person
Iradj Maleki
Street address
Unit No. 602, Savalan Building, Kooyetavakol St, Farhang St, Sari
City
Sari
Province
Mazandaran
Postal code
4818867939
Phone
+98 11 4443 0090
Email
iradj2001@yahoo.com

12

Recruitment center
Name of recruitment center
Medical office Abazar parsi MD
Full name of responsible person
Abazar parsi
Street address
4th floor, Aryan building, East Shahrivar Ave., Kianpars St, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6155835829
Phone
+98 61 3336 2787
Email
Dr_abazar_parsi@yahoo.cim

13

Recruitment center
Name of recruitment center
Guilan gastroentrology and hepatology clinic
Full name of responsible person
Fariborz Mansour-Ghanaei
Street address
Guilan Gastroentrology and Hepatology Clinic, Across from science and technology park, Imam Khomeini Avenue, Rasht
City
Rasht
Province
Guilan
Postal code
4136944501
Phone
+98 13 3234 6401
Email
fmansourghanaei@gmail.com
Web page address
https://guilanghclinic.ir

14

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Dr Ali Aliasgari
Street address
Shariati Hospital, Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir/

15

Recruitment center
Name of recruitment center
Masoud Clinic
Full name of responsible person
Amir Ali Sohrabpour
Street address
No. 114, 19th Alley, North Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1439963553
Phone
+98 21 5453 4000
Email
Aasohrabpour@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
6th Floor, The headquarters of Tehran University of Medical Sciences , Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Fax
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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

2

Sponsor
Name of organization / entity
Dr. Abidi Pharmaceuticals
Full name of responsible person
‏Afsaneh Mirshahvelayati
Street address
No. 72, Abidi Blvd., Shahid Lashgari Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1389776363
Phone
+98 21 4452 2451
Fax
Email
info​@abidipharma.com​
Web page address
https://www.abidipharma.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr. Abidi Pharmaceuticals
Proportion provided by this source
99
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Molaei
Position
Research Assist
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Digestive Disease Research Institute, Shariati Hospital, Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5104
Email
molaei.mahdi78@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anahita Sadeghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroentrology
Street address
Digestive Disease Research Institute, Shariati Hospital, Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5104
Fax
Email
a-sadeghi@tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Molaei
Position
Research Assist
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Digestive Disease Research Institute, Shariati Hospital, Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8241 5104
Email
molaei.mahdi78@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 the data will be published after the study is completed. Individual identifiers will be removed when approval by the scientific team. IPD sharing will be limited to data on primary outcome, secondary outcomes, and demographic information.
When the data will become available and for how long
Access begins: after publication of the original article
To whom data/document is available
Researchers affiliated with universities or non-profit scientific institutions. Researchers in the fields of medicine, epidemiology, public health, and pharmacology
Under which criteria data/document could be used
For independent scientific analyses, systematic reviews or meta-analyses
From where data/document is obtainable
Address: Digestive Diseases Research Center, Digestive Diseases Research Institute, Tehran University of Medical Sciences, Tehran, Iran Email: molaei.mahdi78@gmail.com, anahitasadeghim@gmail.com Phone: 09966993304
What processes are involved for a request to access data/document
The official request has to be sent to the email address provided. The research team will respond within 30 days. If approved, access will be provided under a formal agreement (MOU).
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