Overview
The goal of this clinical trial is to compare the efficacy and safety of vonoprazan-based levofloxacin-containing triple therapy with esomeprazole-based levofloxacin-containing triple therapy for eradication of Helicobacter pylori infection in adults with dyspepsia.
The main questions it aims to answer are whether vonoprazan-based triple therapy achieves a higher eradication rate of H. pylori, whether it provides greater improvement in dyspeptic symptoms, and what adverse effects are associated with each regimen.
Researchers will compare the two treatment regimens to determine which is more effective for H. pylori eradication.
Participants with confirmed H. pylori infection will be randomly assigned to receive either vonoprazan-based or esomeprazole-based triple therapy for 14 days.
Four weeks after completion of therapy, participants will undergo repeat stool antigen testing to assess eradication.
Drug compliance, adverse effects, and dyspeptic symptom scores will be recorded during follow-up.
Participants with endoscopic mucosal lesions at baseline will undergo follow-up endoscopy for reassessment.
Description
This open-label randomized controlled trial will be conducted in the outpatient Department of Gastroenterology, Bangabandhu Sheikh Mujib Medical University (BMU), following institutional ethical approval. Consecutive adult patients presenting with dyspepsia or symptoms suggestive of peptic ulcer disease will be initially evaluated for enrollment. Eligible patients will undergo screening for Helicobacter pylori infection using a stool antigen test. Fresh stool samples will be collected in sterile containers and analyzed using a one-step chromatographic immunoassay for H. pylori antigen detection.
Patients with positive stool antigen results will undergo upper gastrointestinal endoscopy after assessment of procedural fitness and obtaining written informed consent. Endoscopy will be performed by experienced gastroenterologists using standard endoscopic equipment. During endoscopy, mucosal abnormalities including gastritis, erosions, duodenal ulcers, and gastric ulcers will be documented in a structured data collection form. Biopsy specimens from the gastric antrum and corpus will be obtained for rapid urease testing. Additional biopsies will be taken from suspicious lesions when clinically indicated.
Only patients with positive results on both stool antigen testing and rapid urease testing will be enrolled in the study. Enrolled participants will be randomly assigned in a 1:1 ratio into two treatment groups. One group will receive vonoprazan-based levofloxacin-containing triple therapy, and the other group will receive esomeprazole-based levofloxacin-containing triple therapy. Both treatment regimens will be administered for 14 days. Participants will be instructed regarding medication timing and adherence.
All study medications will be supplied from the same pharmaceutical source and stored under recommended conditions. Participants will be followed at the end of therapy to assess treatment compliance and document any adverse events. A subsequent follow-up visit will be scheduled 4 weeks after completion of therapy, during which repeat stool antigen testing will be performed to assess H. pylori eradication. Participants with mucosal lesions identified at baseline endoscopy will undergo repeat upper gastrointestinal endoscopy to evaluate mucosal healing.
All study findings, including eradication outcomes, treatment adherence, adverse effects, and endoscopic healing status where applicable, will be systematically documented and analyzed upon completion of follow-up.
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).
Eligibility
Inclusion Criteria:
- Age ≥ 18 years
- Dyspeptic patients with positive for both rapid urease test and stool antigen test
- Patients giving written informed consent
Exclusion Criteria:
- Treatment with a proton pump inhibitor, H2-receptor antagonist within the last 2 weeks, prior to the study
- Treatment with antibiotics or bismuth preparation within 4 weeks prior to the study
- Previous H. pylori eradication therapy
- Gastric or duodenal ulcer with current or recent bleeding on endoscopy
- Significant upper or lower gastrointestinal bleeding within 4 weeks
- Patients with regular intake of NSAIDs or steroids
- Surgery that might affect gastric acid secretion e.g., upper GI resection or vagotomy
- Known case of malignancy, including MALToma
- Advanced co-morbidities (e.g., CLD, CKD, cardio-respiratory failure, known thyroid disease)
- Chronic alcohol abuse, chronic illegal drug use, or drug addiction within the past 12 months
- Pregnant, lactating woman or intend to become pregnant within the study period
- History of hypersensitivity to vonoprazan, PPIs, amoxicillin, and/or levofloxacin
- On colchicine
- Subjects with abnormal laboratory test at the start of the screening period:
- creatinine \> 2 mg/dl SGPT \> 2 x Upper limit of normal
