Comparison Between Vonoprazan-Based Triple Therapy and Esomeprazole-Based Triple Therapy for Eradication of Helicobacter Pylori Infection: An Open-Label Randomized Controlled Trial
Phase: PHASE4
Conditions: Helicobacter Pylori Infection, Dyspepsia, Peptic Ulcer Disease, Helicobacter Pylori, H Pylori
Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

 
 
Thesis Protocol 
Comparison between vonoprazan-based triple therapy and esomeprazole-
based triple therapy for eradication of Helicobacter pylori infection: An open-
label randomized controlled trial 
 
 
 
 
 
NCT TRIAL NO: NOT YET ASSIGNED  
DOCUMENT DATE: 09.04.2026 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 

   Abstract for Institutional Review Board (IRB) 
 
Title: Comparison between vonoprazan-based triple therapy and esomeprazole-based triple 
therapy for eradication of Helicobacter pylori infection: An open-label randomized controlled 
trial 
 
Background: Helicobacter pylori infection is one of the most common infections worldwide and 
is responsible for various upper gastrointestinal (GI) diseases. It is an important cause of dyspepsia. 
Eradication of H. pylori is a major challenge due to growing widespread anti-microbial resistance 
and a lack of effective anti-H. pylori eradication therapy. There are multiple regimens for H. pylori 
eradication, but the efficacy of these regimens depends on the local antibiotic resistance pattern. 
Among the different regimens studied in Bangladesh, levofloxacin-based triple therapy has shown 
the best efficacy. However, a recent study in Bangladesh showed clarithromycin, metronidazole, 
and levofloxacin resistance rates of 39.3%, 94.6%, and 66.1%, respectively. On the contrary, 
amoxicillin resistance is quite low, at 3.6%. In comparison to proton pump inhibitors (PPI), 
vonoprazan is superior in maintaining a neutral pH in the stomach over a 24-hour period and 
enhancing the bactericidal activity of amoxicillin on H. pylori. Among PPIs, esomeprazole has 
better potency in acid inhibition than other PPIs. So, a new treatment strategy to use vonoprazan 
in place of esomeprazole in levofloxacin- containing triple therapy may combat antimicrobial 
resistance.  
 
Objective: To assess and compare the efficacy of vonoprazan-based triple therapy and 
esomeprazole -based levofloxacin-containing triple therapy for the eradication of Helicobacter 
pylori 
 
Materials and methods: This open-label randomized controlled study will be carried out in the 
department of Gastroenterology, BSMMU. Patients with dyspepsia coming to the outpatient 
department fulfilling inclusion and exclusion criteria, being able to read and/or comprehend the 
questionnaire will be offered a stool antigen test for H. pylori detection. Stool antigen test- positive 

patients will be offered an upper GI endoscopy with a rapid urease test. Patients will be considered 
H. pylori positive if both tests are positive. Then these positive patients will be randomly assigned 
into two groups through computer software. One group will receive vonoprazan-based 
levofloxacin containing triple therapy (VAL) containing amoxicillin 1 gm twice daily, levofloxacin 
500 mg once daily, and vonoprazan 20 mg twice daily for 14 days. Another group will receive 
esomeprazole-based levofloxacin-containing triple (EAL) therapy (amoxicillin 1 gm twice daily, 
levofloxacin 500 mg once daily, and esomeprazole 20 mg twice daily) for 14 days. Patients will 
be declared infection-free if a repeat stool antigen test is negative one month after the completion 
of eradication therapy. Whoever had an endoscopic mucosal lesion at enrollment will be offered a 
follow-up endoscopy four weeks later for evaluation of the mucosal lesion. Drug compliance and 
side effects will be recorded. The dyspeptic symptoms score through a 5-point Likert scale will 
also be recorded at baseline and 1 month after completion of eradication therapy. 
 
Duration of study: April 2026 to August 2026 
 
Data analysis: The data will be analyzed using SPSS version 27 software. Statistical analysis will 
be done by the student’s t-test, Chi-square test, or Fisher’s exact test, as appropriate. A P-value of 
< 0.05 will be considered statistically significant. 
 
Ethical consideration: Every ethical issue will be discussed with the patient regarding the study, 
and informed written consent will be obtained. There will be no chance of disclosure of 
information that will have been harmful to the patients or others. Permission will be obtained from 
the concerned departmental ethical committee as well as the ethical review committee of BSMMU 
in order to carry out the study. 
 
 
 
 

Introduction 
Helicobacter pylori (H. pylori) is a slow-growing, microaerophilic, S-shaped, highly motile, gram-
negative bacterium. It is located on the luminal surface of the gastric epithelium. It was first 
isolated by Warren and Marshall in 1982, and they were awarded the Nobel Prize in 2005 
(Malfertheiner et al., 2023). H. pylori infection can cause gastritis, gastric and duodenal ulcers, 
and mucosa-associated lymphoid tissue lymphoma (McColl, 2010). Furthermore, H. pylori was 
classified as a group 1 carcinogen by the World Health Organization and the International Agency 
for Research on Cancer. Prompt removal of this primary risk factor for gastric carcinoma can 
reduce 75% of the risk (Savoldi et al., 2018; Kumar et al., 2020; and News release by Philadelphia, 
Pennsylvania, 2019). 
 
According to Hooi et al. (2017), over 50% of people worldwide have H. pylori infection. The 
prevalence of 
the infection 
varies among populations and 
is more common in 
developing 
countries (Eusebi et al., 2014; Frenck and Clemens, 2003). Bangladesh has the highest frequency 
of H. pylori infection (86.3%) in South Asia (Kharel et al., 2020). A pilot study showed that 92% 
of participants had H. pylori infection (Ahmad et al., 1997). A semi-urban study close to Dhaka 
revealed that the prevalence of infection was 92.7% (Nahar et al., 2018). 
 
H. pylori has been treated with various regimens, with varying results. Antibiotic resistance is the 
main 
concern 
for 
management 
and 
eradication 
of 
H. 
pylori. 
Suzuki 
et 
al. 
(2019) reported an increase in metronidazole and fluoroquinolone resistance globally, in addition 
to clarithromycin. A study conducted in Bangladesh found that 39.3% of people were resistant to 
clarithromycin, 94.6% to metronidazole, and 66.1% to levofloxacin. However, only 3.6% had 
amoxicillin resistance (Aftab et al., 2016). 
 
According to Maastricht’s VI recommendation, susceptibility testing should ideally be performed 
prior to giving first-line therapy. But it is not always practically, economically, or logistically 
feasible in Bangladesh. In areas of high (>15%) or unknown clarithromycin resistance, it is advised 
to treat H. pylori with bismuth quadruple or non-bismuth concomitant quadruple therapy. If it fails 
or is not available, levofloxacin triple or quadruple therapy is advised for 14 days (Malfertheiner 
et al., 2022). 

 
Avoiding problems related to antibiotic resistance has become an important issue regarding the 
selection of a proper anti-H. pylori regimen. Bismuth salts decrease the bacterial load. Complex 
treatment regimens and adverse effects of bismuth-based or non-bismuth-based quadruple therapy 
lead to poor compliance and thus decrease the eradication rate (Kuo et al., 2009). Moreover, 
bismuth salts are not yet available in Bangladesh.  
 
A double-blind randomized placebo-controlled clinical trial conducted in Bangladesh in 2016 in 
H. pylori eradication in functional dyspepsia showed that the efficacy of levofloxacin-based triple 
therapy was 56.5% (Arefin et al., 2023). The efficacy of levofloxacin-based triple therapy for H. 
pylori eradication in peptic ulcer disease was 78.6% in a study in Bangladesh (Ahmed et al., 2009). 
This rate was the highest eradication rate for H. pylori among previous studies conducted in 
Bangladesh using different regimens. 
 
The efficacy rate of PPI-based regimens has progressively decreased in the past few years, and the 
inadequate acid suppression effect is deemed non-negligible (Yang et al., 2022). Antibiotic like 
amoxicillin can be more stable and concentrated when intra-gastric pH levels are raised; however, 
H. pylori can become drug-susceptible, replicative when acid suppression is prolonged and strong 
enough (Graham et al., 2008; Sugimoto et al., 2007). On the other hand, the prodrug PPI has a 
short half-life and a delayed commencement of action due to CYP2C19 polymorphisms and diet 
(Shin et al., 2011; Mori et al., 2019). So it is critically necessary to identify and employ excellent 
acid inhibitors in the H. pylori eradication technique. However, esomeprazole is reported to have 
higher potency in acid inhibition than other PPIs (Kalaitzakis & Bjornsson, 2007).  
 
 
A potassium-competitive acid blocker, vonoprazan, reversibly inhibits H+/K+ ATPase without 
requiring acid activation, and its mechanism of action is similar to that of PPIs. Furthermore, 
compared to PPIs (eg. Esomeprazole), vonoprazan can reduce gastric acid output more quickly, 
strongly, and for a longer period of time due to several pharmacological properties (Shin et al., 
2011; Mori et al., 2019). This prolonged action and effective acid suppression will allow the 
replication of H. pylori and thus result in more killing of bacteria and more effective eradication 

of H. pylori. Compared to esomeprazole, it is mainly metabolized by Cytochrome P450 (CYP) 
3A4, and its efficacy is not hampered by CYP2C19 polymorphism (Abdelghani et al., 2023) 
In a meta-analysis of Asian studies, PPI-based triple therapy achieved considerably lower 
eradication rates than the triple combination of vonoprazan, amoxicillin, and clarithromycin, even 
in patients with strains of antibiotic resistant to clarithromycin (Li et al., 2018). In Egypt, 
levofloxacin-based triple therapy involving either vonoprazan or esomeprazole showed that 
vonoprazan-based triple therapy had a better eradication rate than the esomeprazole-based one 
(97.7% vs. 68.5%, P = 0.031) (Abdelghani et al., 2023). So, the addition of vonoprazan to 
levofloxacin-based triple therapy in place of esomeprazole needs further research. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Rationale of the study 
Due to the growing prevalence of anti-microbial resistance and the lack of an efficient anti- H. 
pylori regimen, eradicating H. pylori poses a significant challenge for health care professionals. 
High clarithromycin resistance precludes its use as a component of triple therapy. Bismuth 
component are not yet available in our country. Though levofloxacin resistance is also high in our 
country, levofloxacin-based triple therapy regimen has demonstrated satisfactory efficacy among 
different regimens of anti-H. pylori therapy in different clinical trials conducted in Bangladesh so 
far.  Levofloxacin is well- tolerated and safe, with a mild to moderate side-effect profile. On the 
other hand, since its discovery, vonoprazan has been used in reflux esophagitis, peptic ulcer 
disease, and for H. pylori eradication. Like PPI, vonoprazan also suppresses gastric acid secretion. 
As vonoprazan is an active drug, vonoprazan is more rapid-acting than PPI. Vonoprazan is more 
potent and long-acting than PPI in suppressing gastric acid and so it enhances more time-dependent 
bactericidal action of antibiotic. Moreover, its efficacy is not hampered by diet and gene 
polymorphisms. Vonoprazan-based anti- H. pylori therapy has shown better efficacy than the PPI-
based one. Eradication rate is also higher with vonoprazan in comparison to PPI even in 
clarithromycin-resistant H. pylori infection. So, replacing PPI with vonoprazan may improve the 
eradication rate of levofloxacin-based triple therapy. As esomeprazole has higher potency in acid 
inhibition, esomeprazole will be used among the PPIs. There was no study conducted in our 
country comparing the efficacy of vonoprazan-based triple therapy with esomeprazole-based triple 
therapy for the eradication of H. pylori infection. Therefore, this study will be conducted to 
compare the efficacy of vonoprazan-based versus esomeprazole-based levofloxacin-containing 
triple therapy for the eradication of H. pylori infection. 
 
 
 
 
 
 

Research question 
Is there any difference in the efficacy between vonoprazan-based triple therapy and esomeprazole-
based triple therapy in the eradication of Helicobacter pylori infection? 
 
Research hypothesis 
Null hypothesis 
There is no difference in the efficacy between vonoprazan-based triple therapy and esomeprazole-
based triple therapy in the eradication of Helicobacter pylori infection. 
Alternate hypothesis 
There is difference in the efficacy between vonoprazan-based triple therapy and esomeprazole-
based triple therapy in the eradication of Helicobacter pylori infection. 
 
 
 
 
 
 
 
 
 
 
 
 

Objectives of the Study 
General objective:  
To compare the efficacy of vonoprazan-based levofloxacin-containing triple therapy with 
esomeprazole-based levofloxacin-containing triple therapy for the eradication of Helicobacter 
pylori infection 
 
Specific objectives:  
1. To identify H. pylori infection on the basis of both stool antigen test and rapid urease test among 
dyspeptic patients 
2. To determine H. pylori status on the basis of stool antigen test 4 weeks after vonoprazan-based 
triple therapy 
3. To determine H. pylori status on the basis of stool antigen test 4 weeks after esomeprazole-based 
triple therapy 
4. To assess the efficacy of vonoprazan-based triple therapy for H. pylori eradication 
5. To assess the efficacy of esomeprazole-based triple therapy for H. pylori eradication 
6. To compare the efficacy between two groups for H. pylori eradication 
7. To compare percentage of patients with healed endoscopic mucosal lesion between two groups 
4 weeks after completion of treatment  
8. To compare the improvement of dyspepsia symptoms score within and between the groups after 
4 weeks of completion of treatment  
9. To see the adverse effects between the groups 

Research Methodology 
Study design: Open-label randomized controlled trial 
 
 
Place of study: Department of Gastroenterology, BSMMU, Dhaka.  
 
Study period: April 2026 to August 2026 
 
Study population: Patients with dyspeptic symptoms attending the outpatient department of 
Gastroenterology, BSMMU, Dhaka  
Sampling technique: Consecutive sampling  
Randomization method: Block randomization 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Selection criteria for the patients 
 
Inclusion criteria:  
1. Age ≥ 18 years  
2. Dyspeptic patients with positive for both rapid urease test and stool antigen test 
3. Patients giving written informed consent 
 
Exclusion criteria:  
1. Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks,  prior to 
the study 
2. Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study 
3. Previous H. pylori eradication therapy 
4. Gastric or duodenal ulcer with current or recent bleeding on endoscopy 
5. Significant upper or lower gastrointestinal bleeding within 4 weeks 
6. Patients with regular intake of NSAIDs or steroids 
7. Surgery that might affect gastric acid secretion e.g., upper GI resection or vagotomy 
8. Known case of malignancy, including MALToma 
9. Advanced co-morbidities (e.g., CLD, CKD, cardio-respiratory failure, known thyroid  disease) 
10. Chronic alcohol abuse, chronic illegal drug use, or drug addiction within the past 12 months  
11. Pregnant, lactating woman or intend to become pregnant within the study period 
12. History of hypersensitivity to vonoprazan, PPIs, amoxicillin, and/or levofloxacin 
13.  On colchicine 
14. Subjects with abnormal laboratory test at the start of the screening period: 
S. creatinine > 2 mg/dl 
   
SGPT > 2 x Upper limit of normal 
15. History of interstitial nephritis, prolonged QT interval on ECG 

16. Sample size calculation  
      Formula: 
n = 
2
2
2
1
2
2
1
1
)
(
)
(
)
1(
)
1(


Z
Z
x
P
P
P
P
P
P
+






−
−
+
−
 
n = sample size for each group 
P1= Outcome of intervention group (vonoprazan-based triple therapy) = 0.977 (Abdelghani et al., 
2023). 
P2= Outcome of control group (esomeprazole-based levofloxacin-containing triple therapy) = 
0.685 (Abdelghani et al., 2023). 
Zα=Z-value at 5% level of significance = 1.96  
Zβ= Z-value at 95% power = 1.645  
n= 36 
 
Calculated sample size in each group= 36 
Assuming 10% drop out,  
N= [
𝟑𝟔
𝟎.𝟗]
 
  = 40 
n = 40 in each group 
Total number of patients in the study =40+40 = 80 
 
 
 
 

Operational definitions 
Dyspepsia: Dyspepsia is derived from dys and pepse and literally means “difficult digestion.”  In 
this study, dyspepsia will be defined as the presence of one or more of the following symptoms: 
epigastric pain, postprandial fullness, early satiation, anorexia, belching, nausea and vomiting, 
upper abdominal bloating, and even heartburn and regurgitation. (Tack et al., 2004).  
 
H. pylori infection: Patients will be considered H. pylori infection positive if both the rapid urease 
test and stool antigen test are positive at enrollment 
 
H. pylori eradication: If the stool antigen test is negative 1 month after the completion of 
eradication therapy, patients will be considered cured of H. pylori infection (Malfertheiner et al. 
2022). 
 
Vonoprazan-based (levofloxacin-containing) triple therapy: Amoxicillin 1 gm twice daily, 
levofloxacin 500mg once daily & vonoprazan 20 mg twice daily for 14 days (Abdelghani et al., 
2023) 
 
Esomeprazole-based (levofloxacin-containing) triple therapy: Amoxicillin 1 gm twice daily, 
levofloxacin 500mg once daily & esomeprazole 20 mg twice daily for 14 days (Chey et al., 2017) 
 
Rapid urease test (RUT): RUT will detect the urease enzyme of Helicobacter pylori in gastric 
mucosal biopsies. H-P TEST (Lenus Medicare & Research (OPC) Private Limited®) slide will be 
used for the study. After introduction of biopsy specimen to yellow media of H-P test slide and 
addition of one drop of sterile water, if color changes from yellow to pink or red at 2 minutes to 
10 minutes, test will be considered H. pylori positive. 
 
Stool antigen test: It is a rapid, immunochromatographic assay for the detection of Helicobacter 
pylori antigen in human feces sample. It is an appropriate test before and after anti-H. pylori 
therapy. ONE STEP H. pylori Ag Test (InTec PRODUCTS, INC®) kit will be used. After addition 
of feces sample in the sample pad, if formation of colored band occurs in the test region at 15-20 
minutes, it will be considered as H. pylori  positive. 

 
Patient’s dyspepsia symptom score: This is a patient-completed measure of disease. In this 
scoring system, impact of eight symptoms related to dyspepsia on quality of life is graded on 5-
point Likert scale over the last two weeks. Score is graded from no problem (1 point) to very 
severe problem (5 point)                                                   
 
 
 
No problem  
 
Mild problem 
 
Moderate 
problem 
Severe 
problem 
Very severe 
problem 
Post prandial 
fullness  
 
 
 
 
 
Early satiety  
 
 
 
 
 
Epigastric pain (a 
sharp, easy to 
pinpoint pain after 
eating) 
 
 
 
 
 
Epigastric 
discomfort (an ache 
or discomfort after 
eating, poorly 
localized) 
 
 
 
 
 
Upper abdominal 
bloating  
 
 
 
 
 
Belching after 
meals 
 
 
 
 
 
Postprandial 
nausea  
 
 
 
 
 
Vomiting 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
       Talley et al., 2000  
 
 
 

List of Variables: 
Demographic variables  
1. Age 
2. Gender 
Independent variables  
1. 
Vonoprazan-based levofloxacin-containing triple therapy  
2. 
Esomeprazole-based levofloxacin-containing triple therapy 
3. 
Stool antigen test  
 
Outcome variable 
1. Percentage of negative stool antigen test for H. pylori 4 weeks after treatment completion 
2. Percentage of patients with healed endoscopic mucosal lesion 
3. Mean change of dyspepsia symptom score on 5-point Likert scale 
4. Adverse drug reaction rates 
 
 
 
 
 
 
 
 
 
 
 
 

 
Study procedure 
Data collection:  
Consecutive patients of both dyspepsia and symptoms of peptic ulcer disease will initially be 
evaluated from the patients who will attend the outpatient department of gastroenterology of 
BSMMU. Patients, with past history of PPI, H2-receptor blocker intake within last 2 weeks, or 
antibiotic or bismuth preparation intake within 4 weeks prior to study, or previous history of intake 
of anti- H. pylori therapy, will be excluded from the study.  Who had history of gastric ulcer with 
significant bleeding, will be also excluded. Fresh stool sample will be sent for stool antigen test. 
A one-step chromatographic immunoassay (ONE STEP H. pylori Ag Test - InTec PRODUCTS, 
INC® kit) will be used to perform the stool antigen test. After proper evaluation and ensuring that 
the patient is fit for endoscopy, patients who test positive for stool antigen will proceed to have an 
upper GIT endoscopy. Informed written consent will be taken for upper GIT endoscopy. 
Endoscopy will be done by expert endoscopist of the department, and Olympus GIF-H190 
endoscopy machine will be used. Patients with endoscopic finding of peptic ulcer with current 
bleeding, and history of upper or lower GIT bleeding within previous 4 weeks, will be excluded, 
and will be dealt according to guideline. Any mucosal lesion (such as erosion, gastritis, duodenal, 
or gastric ulcer) will be recorded in the data sheet, and biopsy (one from the antrum and one from 
the corpus) will be taken for a rapid urease test (H-P TEST- Lenus Medicare & Research® (OPC) 
Private Limited). If a lesion looks suspicious, an additional biopsy will also be taken. The study 
will eventually include patients who test positive for both the stool antigen test and rapid urease 
test. A 5-point Likert scale will be used to record dyspeptic symptoms at the time of enrollment. 
 
Selected 80 patients will then be randomly assigned into two groups: Group A and Group B, with 
40 patients in each group. Groups A and B will receive vonoprazan-based (VAL) and 
esomeprazole-based (EAL) levofloxacin-containing triple therapy for 14 days, respectively. In 
both groups, amoxicillin 1 gm twice daily and levofloxacin 500 mg once daily will be taken after 
meal. Vonoprazan or esomeprazole 20 mg twice daily will be taken 30 minutes before meal in 
groups A & B respectively for 14 days. Even in patients with uncomplicated ulcers, 14-day anti-
secretory regimen will be given (Gisbert et al., 2005; Kamada et al., 2021).  All the drugs will be 

supplied from same pharmaceutical. All the medicines will be stored at room temperature  between 
15 to 25 degree Celsius in a cool, dry place away direct sunlight. Patient will be asked for follow-
up at the end of the therapy. Drug compliance and adverse effects will be noted at that time. Patients 
will be asked for 2nd follow-up 4 weeks later. Then, all the patients will have a repeat stool antigen 
test to confirm eradication. Each group's H. pylori eradication will be documented. Repeat upper 
GIT 
endoscopy 
will 
be 
performed on 
patients 
who 
had 
mucosal 
lesions 
at 
enrollment in order to re-evaluate 
the 
lesions. 
One 
month 
following the end of 
therapy, each group's dyspeptic symptoms will also be recorded using a 5-point Likert scale to see 
if there has been any improvement. 
 
 
Data collection tools:  
1. Data collection form  
2. 5 point Likert scale score for assessment of dyspepsia 
 
Statistical analysis:  
The following steps will be used to analyze the collected data: 
• 
The entered data will be checked, verified and analyzed by IBM® SPSS® Statistics version 27 
(Statistical Program for Social Science) software.  
• 
The data will be presented in tables, figures and diagrammatical form.  
• 
Appropriate statistical test will be applied for data analysis. Numeric data (e.g. age, Likert scale 
score for dyspepsia) will be expressed as mean ± standard deviation and median (range), 
qualitative data (e.g. sex, stool antigen test, endoscopy of upper GIT) will be expressed as 
frequency and percentage.  
• 
Baseline characteristics of the study patients and outcomes will be evaluated using student’s t-test, 
Chi-square test or Fisher’s exact test, as appropriate.  
• 
Factors influencing the efficacy of the eradication therapy were assessed by univariate & 
multivariate analysis 
• 
A P-value less than 0.05 will be considered as significant at a 95% confidence interval 
(95%  CI).  

 
Utilization of the study results  
The study will be able to assess the efficacy and adverse effects of vonoprazan-based and 
esomeprazole-based levofloxacin-containing triple therapy for the eradication of H. pylori 
Infection.  So, this study enables clinicians to find a new alternative to existing eradication regime 
to improve individual patient care. 
Ethical issue  
Throughout the study, following factors will be taken into account: 
• 
The patients and important family memberts will be fully aware of the objectives and limitations 
of the study. 
• 
They will be informed that there is no risk to participatants’ safety, either socially or physically. 
• 
They will also be informed about the freedom to participate or not to participate at any time.   
• 
Written consent will be obtained from the participants.  
• 
No information about the patient would be shared with outside parties. 
• 
The participants in the study will not receive any compensation for their participation.  
• 
The Institutional Review Board (IRB) will be consulted for ethical clearance. 
 
Conflict of interest 
 None declared 
 
Quality assurance strategy 
This will be an open-label randomized controlled trial. Extensive literature review will be done 
and investigator will be sufficiently trained. Inclusion and exclusion criteria will be strictly 
maintained. Every step of the study will be carried out under direct supervision of the guide. The 
completeness and quality of the collected data will be ensured by regular and routine supervision, 
checking and monitoring. Guide will randomly scrutinize the data collection procedure. Gathered 
information from patient will be checked and rechecked with medical record. Schedule meeting 
will be arranged with the guide regularly to discuss the progress of data collection. Data cleaning 
will be done before editing in the computer for analysis. After obtaining results of one quarter of 
the study subjects, review meeting will be arranged with the guide and emerged issue will be 

addressed properly. Before entering data in computer for analysis random checking of 10% of data 
will be done by the guide. Irrelevant and inconsistent data will be discarded. After collection of 
data, meeting will be arranged with guide at weekly interval to discuss about the progress of thesis 
writing and submission.  
 
 
 
Confidentiality  
All the information collected from the patients including the results of the laboratory tests will be 
kept as confidential under the responsibility of principal investigator. No one other than the 
investigators, regulatory authorities and institutional review board committee will have access to 
such information. Patient’s identity will not be disclosed while analyzing or publishing the results 
of the study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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gastroenterology, 56(4), pp. 303–322.  
 
Kharel, S., Anil, Shrestha, Suraj & Sushan, H. (2020) ‘Helicobacter pylori healthy South Asians’,  
JGH Open, 4, pp. 1037-46 
 
 
Kumar, Shria, Metz, D. C., Ellenberg, S., David, E., Kaplan and Goldberg, D. S. (2020) ‘Risk 
Factors and Incidence of Gastric Cancer after Detection of Helicobacter Pylori Infection: A Large 
Cohort Study’, Gastroenterology, 158 (3), pp. 527-536.e7 
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therapy for Helicobacter pylori infection after standard triple therapy: a randomized controlled 
trial’, The Journal of antimicrobial chemotherapy, 63(5), pp. 1017-1024 
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‘Systemic review with meta-analysis: Vonoprazan, a potent acid blocker, is superior to proton-
pump inhibitors for eradication of chlarithromycin-resistant strains of Helicobacter pylori’, 
Helicobacter, 23(4), pp. e12495 
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(2022) ‘Management of Helicobacter Pylori Infection: The Maastricht VI/Florence Consensus 
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                                               Abbreviations 
Anti-HCV 
Anti- Hepatitis C Virus 
BP 
Blood pressure 
BSMMU 
Bangabandhu Sheikh Mujib Medical University 
CI 
 
Confidence Interval 
CKD   
Chronic Kidney Disease 
CLD 
Chronic Liver Disease 
CYP 
Cytochrome P450  
EAL 
Esomeprazole-Amoxicillin-Levofloxacin 
GIT 
Gastrointestinal tract 
HBsAg 
Hepatitis B virus surface Antigen 
IRB 
 
Institutional Review Board 
ITT 
Intention-to-treat analysis 
 
MALT 
Mucosa Associated Lymphoid Tissue 
NSAID 
Non-steroidal Anti-inflammatory Drug 
OPD 
Outdoor Patient Department 
PP 
Per protocol analysis 
PPI 
Proton Pump Inhibitor 
RUT 
Rapid Urease Test 
SAT   
Stool Antigen Test 
SGPT 
Serum Glutamate Pyruvate Transaminase 
SPSS 
Statistical Package for Social Science  
VAL   
Vonoprazon-Amoxicillin-Levofloxacin 
WHO 
World Health Organization 
 
 
 
 
 
 

Appendix II 
Budget details 
Budget estimation for the thesis work 
SI. No. 
 
Particulars 
Cost (TK) 
 
1. 
 
Investigations  
 
484000 tk 
2. 
 
Literatures 
 
5,000 tk 
 
3. 
 
Stationary 
 
5,000 tk 
 
4 
Protocol preparation, compose and printing 
10,000 tk 
 
5. 
 
Data editing and analysis 
20,000 tk 
 
6. 
 
Drugs 
 
69,440 tk 
 
 
Total 
 
5,93,440  tk 
 
Cost of investigations: 
● Complete blood count: 350 tk 
● ECG: 100 tk 
● S. Creatinine 80 tk 
● SGPT  120 tk 
● HBsAg  350 tk 
● Anti-HCV 600 tk 
● Rapid urease test: 450 tk 
● Endoscopy of upper GIT: 1200 tk (baseline & 4 weeks after treatment) 
● Stool antigen test: 800 tk (baseline & 4 weeks after treatment) 
 
Investigation cost in each patient: 6050 tk  
Total investigation cost: 484,000 tk 
Cost of medicine: 
Cost of full course of vonoprazan -based  levofloxacin triple therapy group per patient: 910 tk 
Cost of full course in vonoprazan – based levofloxacin triple therapy group patients: 36,400 tk 
Cost of full course in esomeprazole-based levofloxacin triple therapy (EAL) group for each 
patient: 826 tk 
Cost of full course in EAL group patients: 33,040 tk 
Total cost of medicine: 69,440 tk 

Appendix III 
Study flow chart 
 
 
                                     
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Dyspeptic patients visiting OPD of Gastroenterology dept, BSMMU 
Stool antigen test 
positive 
Upper GI endoscopy & rapid urease test 
Both positive 
Randomized into 2 groups 
Dyspeptic symptoms will 
be evaluated by Likert scale 
Group A –Vonoprazan-based triple 
therapy for 14 days 
Group B – Esomeprazole-based triple 
therapy for 14 days 
Drug compliance & side effects will be recorded after completion of therapy 
One month after completion of therapy: 
Repeat Stool antigen test for all patients to confirm eradication  
Upper GI endoscopy for the patients who had mucosal lesion at enrolment  
 
 Dyspeptic symptoms will be evaluated by 5-points Likert scale score 
Data analysis 
Result and Discussion 
Conclusion and Recommendation 

                                                              Appendix-IV 
                                                   Consent form –English 
 
 
INFORMED CONSENT FORM FOR PARTICIPANTS  
Title of research study: Comparison between vonoprazan-based triple therapy and 
esomeprazole-based triple therapy for eradication of Helicobacter pylori infection: An open-
label randomized controlled trial 
 
 
Principal investigator: Dr. Syeda Mubashsharah Mahfuz, MD (Phase-B). (Mobile no: 
01973395139) 
 
Name of participant: ____________________________________ 
 
Place of study: Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University, 
Dhaka 
 
Part 1: Information Sheet 
Introduction: I am Dr. Syeda Mubashsharah Mahfuz, working for the Department of 
Gastroenterology, BSMMU, Bangladesh. We are doing research on efficacy of 2 different drug 
regimens for Helicobacter pylori eradication. I am going to give you information and invite you 
to be part of this research. You do not have to decide today whether or not you will participate in 
the research. Before you decide, you can talk to anyone you feel comfortable with about the 
research.  
There may be some words that you do not understand. Please ask me to stop as we go through the 
information and I will take time to explain.  If you have questions later, you can ask them of me 
or the staff. 

Objective of this consent form: The objective of this informed consent form is to give you 
necessary information that would help you to take decision on whether you will participate or not 
in this study. 
 
Objective and procedure of this research: Lots of patients suffer from dyspepsia & Helicobacter 
pylori infection is an important cause of dyspepsia. There are multiple eradication regimens for H. 
pylori infection but the efficacy of these regimens is not satisfactory, moreover needs multiple 
antibiotics for prolonged period. Our plan is to give 2 different therapeutic regimens to 2 groups 
of patients & compare the efficacy between the 2 groups.  
Type of Research Intervention: This research will involve stool antigen test & endoscopy with 
rapid urease test at baseline followed by H. pylori eradication regimen for 14 days. Repeat stool 
antigen test & endoscopy will be carried out one month after completion of eradication therapy to 
check success of therapy & for the evalution of mucosal lesion. 
 
Participant selection: Patients with dyspepsia visiting the outpatient department of 
Gastroenterology, BSMMU. 
 
Information on stool antigen test: This test will need fresh stool sample for detection of H. pylori 
infection & will be done in the microbiology department, BSMMU. 
 
Information on upper GI endoscopy & rapid urease test: Upper GI Endoscopy involves 
passing a tube with camera into your stomach to see any abnormality. Anesthetic jelly & spray will 
be used to make the procedure comfortable. Endoscopy will be carried out by an experienced 
interventionist. Two biopsy will be taken for rapid urease test which can detect H. pylori infection. 
This procedure will be done in the department of Gastroenterology, BSMMU. 
 
Information on drugs: Levofloxacin, amoxicillin and esomeprazole or vonoprazan will be used 
in this study in two different regimens with different  doses & frequencies. All these medications 
are commonly used for various reasons for long time & well tolerated. Side effects like headache, 
nausea, vomiting, abdominal pain, and rash can occur but are usually not serious and will be 
managed accordingly. 
 
Duration: The research will take place over 6 weeks in total.  

 
Risk of the study: You may face some risk, but the chance is low. There is some risk of headache, 
nausea, vomiting, abdominal pain, diarhoea, rash after taking these medications. You may also 
face endoscopy related hazards like bleeding & perforation but chance of these complications are 
extremely low. We will take necessary precaution and other support to overcome the risk. 
 
Benefits: If you participate in this study, you will get free investigation facility, free treatment, 
free follow-up during study period.  
 
Alternatives: You have the right to participate in this study or not, or to withdraw from the study 
at any stage of this research. 
Cost: You will not have to bear any extra cost or not be getting any financial benefit for 
participating in this study. 
Confidentiality: Strict confidentiality will be maintained regarding the information of the patients 
during and after the study. Your identity will not be used in data analysis, reporting and publication. 
It will not be disclosed to anybody except the researcher. So, nobody will be able to know your 
personal information. 
Voluntary participation: It is fully a voluntary activity to participate in this research. You may 
not admit participating in this study or you may withdraw yourself at any time of the study which 
will not hamper your treatment in the hospital at all. You will not lose any legal right if you put 
your signature in this form. 
Questions: You can ask any question if you have. I shall try my best to answer your question 
(Mobile no: 01973-395139).  
Declaration:  I am informing you that this collected data sample will only be used for this study 
and no other study. 
 
 
 
 

 
 
Part II: Certificate of Consent: 
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask 
questions about it and any questions that I have asked have been answered to my satisfaction.  I 
consent voluntarily to participate as a participant in this research. 
 
 
Name of Participant__________________ 
  
 
 
 
Signature of Participant ___________________ 
Date ___________________________ 
 
     Day/month/year 
 
  
 
 
 
 
 
 
If illiterate   
I have witnessed the accurate reading of the consent form to the potential participant, and the 
individual has had the opportunity to ask questions. I confirm that the individual has given consent 
freely.  
 
Name of witness_____________________               AND               Thumb print of participant 
Signature of witness ______________________ 
Date ________________________ 
                Day/month/year 
 
 
Statement by the researcher/person taking consent 
I have accurately read out the information sheet to the potential participant, and to the best of my 
ability made sure that the participant understands that. 
I confirm that the participant was given an opportunity to ask questions about the study, and all 
the questions asked by the participant have been answered correctly and to the best of my ability. 
 

I confirm that the individual has not been coerced into giving consent, and the consent has been 
given freely and voluntarily.  
 
 A copy of this ICF has been provided to the participant. 
Name of Researcher/person taking the consent   
_____________________ 
Dr. Syeda Mubashsharah Mahfuz 
 
 
 
 
Signature of Researcher /person taking the consent 
__________________________ 
Date ___________________________ 
 
 
 
                 Day/month/year  
 
 
 
 
 
 
 
 
 
 
 
 
 
                         

Appendix- V 
 
DATA COLLECTION SHEET 
 
Title: Comparison between vonoprazan-based triple therapy and esomeprazole-based triple 
therapy for eradication of Helicobacter pylori infection: An open-label randomized controlled 
trial 
 
Principle Investigator: Dr. Syeda Mubashsharah Mahfuz, MD Phase B, Resident  
Place of study: Department of Gastroenterology, BSMMU  
 
Section A: Particulars of the patient 
 
 
• ID No: ……………                                                         Date: …………. 
 
• Name:………………………………………… 
 
• Father’s Name : 
 
• Mother’s Name: 
 
• Address : 
 
 
• Contact no: 
 
• Hospital Reg. no : …………….. 
 
 
 
 
 
 
GROUP: 

Section B: Socio-demographic profile  
SL 
      Question 
        Answer 
  Code 
  1 
Age   
 Full years 
 
  2 
Sex 
1. Male 
2. Female  
 
 3 
Residence 
1. Urban 
2. Rural 
 
   3 
Religion 
3. Islam 
4. Hinduism 
5. Buddhism 
6. Christian 
 
  4 
Educational qualification 
1. No formal education 
2. Primary [Class 1-5] 
3. Secondary [Class 6-10] 
4. HSC/Equivalent or above 
5. Honours or above 
 
   5 
Marital status 
1. Married 
2. Unmarried 
3. Other 
 
  6 
Occupation 
1. Housewife 
2. Cultivator 
3. Businessman 
4. Garment worker 
5. Student 
6. Day labourer 
7. Teacher 
8. Unemployed 
9. Other 
 
  7 
Monthly income 
Approximately ( In taka ) 
 
  8 
Smoking history 
1. Current smoker 
2. Former smoker 
3. Non-smoker 
 
 
Section C: GI symptoms 
 
• Epigastric pain:                                                Yes=1, No=2                                       |…...….| 
   
• Epigastric burning:                                           Yes=1, No=2                                      |..….….| 
. 

• Postprandial fullness:                                       Yes=1, No=2                                      |..….….| 
 
• Early satiation:                                                 Yes=1, No=2                                      |..….….| 
 
• Anorexia:                                                         Yes=1, No=2                                      |..….….| 
 
• Passage of black tarry stool:                            Yes=1, No=2                                      |..….….| 
 
• vomiting:                                                          Yes=1, No=2                                      |..….….| 
 
• Belching:                                                          Yes=1, No=2                                      |..….….| 
 
• Nausea:                                                            Yes=1, No=2                                       |..….….| 
 
• Weight loss:                                                      Yes=1, No=2                                       |…...….| 
 
• Upper abdominal bloating:                              Yes=1, No=2                                       |..….….| 
    
• Dysphagia:                                                          Yes=1, No=2                                       |..….….| 
 
• Duration of symptoms (months)                                                                                    |..….….| 
 
 
Section D: Co-morbidity  
• Hypertension                                                        Yes=1, No=2                                   |.………| 
• Diabetes                                                                Yes=1, No=2                                    |.………| 
• Coronary artery disease                                        Yes=1, No=2                                   |.………| 
• Others (please mention_____________)               Yes=1, No=2                                   |.………| 
     
Section E: Past medical history  
• Any family history of gastric malignancy         Yes=1, No=2                                   |.………| 
• Any history of abdominal surgery                        Yes=1, No=2                                    |.………| 
• History of antibiotic use in previous year             Yes=1, No=2                                   |.………| 
• Any history of allergy (Food, drugs and 
 environmental) :                                                    Yes=1, No=2                                    |.………| 
 
 
 
 

Physical Examination: 
 
General examination: 
• Weight:………Kg                                  
• Height: ………m 
• BMI: ………Kg/m2 
• Anaemia:  
 
 
 
Present=1, Absent=2                                   |.………| 
 
Systemic examination findings: 
 
 
Laboratory findings at baseline: 
• CBC:  
Hb-…….gm/dl,  
TC of WBC…………/mm3  
ESR ……….  mm in 1st hr. 
• S. creatinine: ……..mg/dl 
• ECG: 
• Upper GIT Endoscopy at baseline: 
    Erosive gastritis                                                       Present =1, Absent=2              |.………| 
    Non-erosive gastritis  
                                    Present =1, Absent =2              |.………| 
    Gastric ulcer                                                            Present =1, Absent =2              |.………| 
    Duodenal ulcer                                                        Present =1, Absent =2              |.………| 
    Others                                                                      Present =1, Absent =2              |.………| 
                                                                     
• Rapid urease test at enrolment:                                Positive =1, Negative=2            |.………| 
• SAT at enrolment:                                                    Positive =1, Negative=2            |.………| 
• SAT 1 month after treatment:                
 
 Positive =1, Negative=2            |.………| 
• Endoscopic mucosal healing after treatment (if present initially):   Yes =1, No=2   |.………| 
 
 

Patient’s dyspepsia symptom score at baseline                                                           |.………| 
 
 
 
No problem  
(ক োন সমসযো কনই)  
Mild problem 
( অল্প সমসযো) 
Moderate 
problem 
(কমোটোমুটি সমসযো)  
Severe 
problem 
(বেশি সমসযো)  
Very severe 
problem 
(খুে কেশি সমসযো)  
Post prandial 
fullness (খোেোবেে পে 
অস্বশি ভোে) 
 
 
 
 
 
Early satiety (অল্প 
কখবে কপট ভবে যোওয়ো) 
 
 
 
 
 
Epigastric pain 
(উপবেে কপবট েযোথো) 
 
 
 
 
 
Epigastric 
burning(উপবেে কপবট 
জ্বোেো  েো) 
 
 
 
 
 
Upper abdominal 
bloating (উপবেে 
কপবট ফুেো ভোে) 
 
 
 
 
 
Belching 
(ক েঁকুে ক োেো) 
 
 
 
 
 
Nausea (েশম ভোে) 
 
 
 
 
 
Vomiting 
(েশম হওয়ো) 
 
 
 
 
 
 
No problem                                           : 1 
(ব োন সমসযো কনই)  
Mild problem                                        : 2 
(অল্প সমসযো)                                         
Moderate problem                                : 3 
(বমোটোমুটি সমসযো)                                
Severe problem                                     : 4 
(বেশি সমসযো)                                      
Very severe problem                            : 5  
(খুে কেশি সমসযো)                            
 
 

Follow up for drug adverse effects: 
  
 
Anorexia                                                                      Yes=1, No=2                          |.………| 
 
Nausea                                                                         Yes=1 , No=2                         |.………| 
 
Vomiting                                                                      Yes=1, No=2                          |.………| 
  
Taste disturbance                                                         Yes=1, No=2                          |.………| 
  
Dizziness                                                                      Yes=1, No=2                         |.………| 
 
Abdominal pain                                                            Yes=1, No=2                         |.………| 
 
Diarrhea                                                                        Yes=1, No=2                         |.………| 
 
Constipation                                                                 Yes=1, No=2                         |.………| 
 
Headache                                                                      Yes=1, No=2                         |.………| 
 
Skin eruption                                                                Yes=1, No=2                         |.………| 
   
Bloating                                                                         Yes=1, No=2                         |.………| 
 
Dry mouth/ throat                                                           Yes=1, No=2                         |.………| 
 
Others: specify (   ……… ………)                                 Yes=1, No=2                         |.………| 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 

Dyspepsia symptom score 1 month after eradication therapy                                |.………| 
 
 
 
No problem  
(ব োন সমসযো কনই)  
Mild problem 
( অল্প সমসযো) 
Moderate 
problem 
(বমোটোমুটি সমসযো)  
Severe 
problem 
(বেশি সমসযো)  
Very severe 
problem 
(খুে কেশি সমসযো)  
Post prandial 
fullness (খোেোবেে পে 
অস্বশি ভোে) 
 
 
 
 
 
Early satiety (অল্প 
কখবে কপট ভবে যোওয়ো) 
 
 
 
 
 
Epigastric pain 
(উপবেে কপবট েযোথো) 
 
 
 
 
 
Epigastric burning 
(উপবেে কপবট জ্বোেো  েো) 
 
 
 
 
 
Upper abdominal 
bloating (উপবেে 
কপবট ফুেো ভোে) 
 
 
 
 
 
Belching 
(ব েঁকুে ক োেো) 
 
 
 
 
 
Nausea (েশম ভোে) 
 
 
 
 
 
Vomiting 
(েশম হওয়ো) 
 
 
 
 
 
No problem                                          : 1 
(ব োন সমসযো কনই)  
Mild problem                                        : 2 
(অল্প সমসযো)                                         
Moderate problem                                : 3 
(বমোটোমুটি সমসযো)                                
Severe problem                                     : 4 
(বেশি সমসযো)                                      
Very severe problem                            : 5 
(খুব ববশি সমসযা)