IRCT | Randomized controlled trial of three Vonoprazan based treatment regimens for eradication of Helicobacter pylori infection: a triple-blind clinical trial study.

Protocol summary

Study aim: Comparison of H. pylori eradication rates among three vonoprazan-based treatment regimens with the shortest treatment duration
Design: The clinical trial will be conducted in a randomized, parallel, triple-blind manner on 330 patients.
Settings and conduct: Patients referred to Motahari Clinic are divided into three groups A, B, and C. Group A patients enter the standard treatment regimen, and group B patients use two mint tablets and green tea in addition to the standard treatment. The secretary randomly gives the patients packets numbered 1 A to A101, 1B to B101, and 1 C to C101, prepared by an independent person. The patients, treating physicians, and the researcher and data analyst are unaware of the type of treatment received. Outcomes are assessed by independent clinical investigators.
Participants/Inclusion and exclusion criteria: Study inclusion criteria: People who have referred to a gastroenterologist and liver specialist with symptoms of indigestion and duodenal ulcer and have a positive pathology test or H. pylori stool antigen. Study exclusion criteria: People who do not have a confirmed H. pylori test or have taken antibiotics for in the past four weeks.
Intervention groups: 1. High-dose vonoprazan and high-dose amoxicillin 7 days 2. Vonoprazan-lefloxacin-bismuth and metronidazole 10 days 3. Omeprazole-amoxicillin-metronidazole and bismuth 14 day
Main outcome variables: Percentage of people whose stool antigen test results and clinical symptoms changed after treatment. Stool antigen test measurement and clinical symptoms assessment after treatment.

General information

Reason for update
Acronym: RCTVREHP
IRCT registration information: IRCT registration number: IRCT20200422047167N2

Registration date: 2026-07-08, 1405/04/17

Registration timing: registered_while_recruiting

Last update: 2026-07-08, 1405/04/17

Update count: 0
Registration date: 2026-07-08, 1405/04/17

Registrant information: Name

Seyedeh Azra Shamsdin

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 71 3628 1442

Email address

shamsdina@sums.ac.ir

Recruitment status: recruiting
Funding source

Expected recruitment start date: 2026-06-22, 1405/04/01
Expected recruitment end date: 2027-02-20, 1405/12/01
Actual recruitment start date: 2026-07-06, 1405/04/15
Actual recruitment end date: 2027-03-11, 1405/12/20
Trial completion date: 2027-03-20, 1405/12/29

Scientific title: Randomized controlled trial of three Vonoprazan based treatment regimens for eradication of Helicobacter pylori infection: a triple-blind clinical trial study.

Public title: Randomized controlled trial of three Vonoprazan based treatment regimens for eradication of Helicobacter pylori infection
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

1- Patients with H. pylori who have a positive written result of urea breath test or stool antigen test or pathological test. 2- Patients who have not received any anti-H. pylori treatment in the past three months. 3- Individuals over 18 years of age.

Exclusion criteria:

1 - Individuals without a confirmed test and a positive written result for H. pylori. 2- Individuals who have been treated for cancer. 3- Patients who have taken antibiotics for any reason in the past four weeks. 4- Patients who have taken immunosuppressive drugs. 5- Individuals with underlying cardiovascular diseases, advanced liver diseases, or renal failure. 6- Pregnant or lactating women.
Age: From 18 years old
Gender: Both

Phase

3

Groups that have been masked

Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board

Sample size

Target sample size: 330

Actual sample size reached: 330

Randomization (investigator's opinion)

Randomized

Randomization description

lock randomization will be used in a 1:1:1 ratio to randomly and equally allocate participants to three treatment groups. Randomization will be performed by an independent individual from the treatment team to prevent any bias in patient allocation. After applying concealed allocation, patients will be divided into three groups in the following manner: 110 envelopes numbered 1 to 110 A, 110 envelopes numbered 1 to 110 B, and 110 envelopes numbered 1 to 110 C. A trained expert will randomly assign one of the envelopes to the patients, and after obtaining informed consent, they will enter the study.

Blinding (investigator's opinion)

Triple blinded

Blinding description

After applying concealed allocation, the patients were divided into three groups in the following manner: 20 packets numbered 1 to 20 A and 20 packets numbered 1 to 20 B were prepared, and a secretary randomly gave one of the packets to the patients, and the people in group A entered the antibiotic treatment regimen, and the people in group B entered the combination treatment regimen of mint tablets and green tea. After providing the necessary explanations and obtaining informed consent, they entered the study. In this study, people who refer to a specialist at Motahari Clinic in Shiraz with symptoms of heartburn and reflux and have a positive H. pylori sampling or breath test will be included in the study. After obtaining written informed consent from the participants, the randomization process will be performed using a random block method with a ratio of 1:1 so that the participants will be randomly placed in one of the two treatment groups. The first group will receive standard H. pylori treatment including antibiotics and omeprazole for one month. The second group will take two herbal medicines, peppermint (Supermint) and green tea (Camellia sinensis), for one month in addition to the standard treatment. The first group will be given a placebo pill of the same shape and size instead of the herbal medicine. The study is designed as a double-blind study, meaning that neither the patients nor the treating physicians will know which treatment they are receiving. Randomization and coding of the drugs will be performed by an independent person from the treatment team. The drug packages will be provided to the patients in the same way and without a name indicating the type of treatment. The outcome assessment will be performed by an independent team of clinical researchers to avoid any bias. After the treatment period (one month), stool samples will be taken from all patients. Fecal antigens will be measured using a special kit using the ELISA method.

Placebo

Not used

Assignment

Parallel

Other design features

In addition to the primary ITT-based analysis, a secondary Per-Protocol (PP) analysis will be conducted, in which only patients who fully complied with the treatment protocol and completed the study follow-up will be included in the analysis. This analysis is performed to assess the effectiveness of the intervention in the context of full adherence to treatment.

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Shiraz University of Medical Sciences

Street address

Shiraz University of Medical Sciences,Zand Avenue, Shiraz ,Iran

City

Shiraz

Province

Fars

Postal code

7193711351
Approval date: 2026-04-27, 1405/02/07
Ethics committee reference number: IR.SUMS.REC.1405.074

Health conditions studied

1

Description of health condition studied: Helicobacter Pylori infection
ICD-10 code: K93
ICD-10 code description: Disorders of other digestive organs in diseases classified elsewhere

Primary outcomes

1

Description: Percentage of people in each of the target groups whose stool antigen test results changed after treatment.
Timepoint: Before starting treatment and after completing the treatment period (6 weeks), stool samples will be taken from all patients to examine Stool Antigen.
Method of measurement: Determination of Helicobacter pylori antigen in feces is measured with a special kit using the ELISA method.

Secondary outcomes

empty

Intervention groups

1

Description: The first Intervention group will receive a drug regimen consisting of 20 mg of vonoprazan four times a day and 1000 mg of amoxicillin four times a day for 7 days. The continuation of this arm will be subject to the results of the interim analysis and subsequent decision-making.
Category: Treatment - Drugs

2

Description: The second Intervention group will receive 20 mg of vonoprazan twice a day and 240 mg of bismuth subcitrate twice a day and 500 mg of amoxicillin four times a day and 500 mg of metronidazole three times a day for 10 days.
Category: Treatment - Drugs

3

Description: The third Intervention group of drug regimens includes omeprazole 20 mg twice a day and bismuth subcitrate 240 mg twice a day and amoxicillin 500 mg four times a day and metronidazole 500 mg three times a day for 14 days.
Category: Treatment - Drugs

Recruitment centers

1

Recruitment center: Name of recruitment center

Motahari Clinic, Shiraz University of Medical Sciences

Full name of responsible person

Seyedeh Azra Shamsdin

Street address

Gastroenterohepatology Research Center,Mohammad Rasoolallah Research Tower,Khalili Street,Shiraz, Iran

City

Shiraz

Province

Fars

Postal code

71348-14336

Phone

+98 71 3212 2290

Fax

+98 71 3212 2295

Email

shamsdina@sums.ac.ir

Web page address

http://sums.ac.ir

1

Sponsor: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Hamid Mohammadi

Street address

Vice President for Research and Technology, Shiraz University of Medical Sciences Central Building - Next to the Red Crescent, Zand Street-Shiraz

City

Shiraz

Province

Fars

Postal code

71348-14336

Phone

+98 71 3235 7282

Fax

+98 71 3212 2430

Email

vcrdep@sums.ac.ir

Web page address

http://research.sums.ac.ir
Grant name: Vice President for Research and Technology, Shiraz University of Medical Sciences,Shiraz
Grant code / Reference number: 34574
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Shiraz 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

Shiraz University of Medical Sciences

Full name of responsible person

Seyedeh Azra Shamsdin

Position

Assistant Professor Immunology

Latest degree

Ph.D.

Other areas of specialty/work

Immunology

Street address

Gasteroenterohepatology Research Center , Mohammad Rasoolallah Research Tower, Khalili Street, Shiraz

City

Shiraz

Province

Fars

Postal code

71348-14336

Phone

+98 71 3628 1442

Fax

+98 71 3628 1442

Email

shamsdina@sums.ac.ir

Web page address

http://sums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Kamran Bagheri Lankarani

Position

Professor, gastroenterologist and hepatologist

Latest degree

Subspecialist

Other areas of specialty/work

Internal Medicine

Street address

Health Policy Research Center,8th Floor,Shiraz Faculty of Medical Sciences, Zand Street,Shiraz

City

Shiraz

Province

Fars

Postal code

7134845794

Phone

+98 71 3208 4440

Fax

+98 71 3230 9616

Email

kblankarani@gmail.com

Web page address

Http://medravabet.sums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Shiraz University of Medical Sciences

Full name of responsible person

Seyedeh Azra Shamsdin

Position

Assistant Professor Immunology

Latest degree

Ph.D.

Other areas of specialty/work

Immunology

Street address

Gasteroenterohepatology Research Center, Mohammad Rasoolallah Research Tower, Khalili Street, Shiraz

City

Shiraz

Province

Fars

Postal code

71348-14336

Phone

+98 71 3628 1442

Fax

+98 71 3628 1442

Email

shamsdina@sums.ac.ir

Web page address

http://sums.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: No - There is not a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: No - There is not 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: Data on the main outcome of participants can be shared after de-identification.
When the data will become available and for how long: Access starts from March 30, 2027
To whom data/document is available: Data will only be available to principal investigators and researchers working in academic and scientific institutions.
Under which criteria data/document could be used: If requested by the supervisor of the project and the reviewers of the article, the authorized data will be provided to the people.
From where data/document is obtainable: Seyedeh Azra Shamsdin
What processes are involved for a request to access data/document: The applicant can request research data by email.
Comments: If the data and their analysis are requested by the supervisor or university referees, they will be provided to them by email.

Randomized controlled trial of three Vonoprazan based treatment regimens for eradication of Helicobacter pylori infection: a triple-blind clinical trial study.