Dyspepsia, Helicobacter Pylori, Helicobacter Pylori Infection, H Pylori, Peptic Ulcer Disease
Conditions
Keywords
Helicobacter pylori, Helicobacter pylori eradication, Vonoprazan, Esomeprazole, Levofloxacin, Triple therapy, Dyspepsia
Brief summary
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.
Detailed 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).
Interventions
DRUGvonoprazan-based triple therapy (VAL regimen)
vonoprazan 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days
DRUGEsomeprazole-based triple therapy (EAL regimen)
Esomeprazole 20 mg twice daily (30 minutes before meal), Amoxicillin 1 g twice daily (After meal), Levofloxacin 500 mg once daily for 14 days
Sponsors
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| H. pylori Eradication Rate | 4 weeks after completion of 14-day therapy | Proportion of participants with confirmed eradication of Helicobacter pylori, defined as a negative stool antigen test performed 4 weeks after completion of therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic Mucosal Healing rate | 4 weeks after completion of therapy. | Proportion of participants with healed gastric or duodenal mucosal lesions assessed by repeat upper gastrointestinal endoscopy 4 weeks after completion of therapy. |
| Change in dyspeptic symptom severity score | 4 weeks after completion of 14-day therapy | Dyspeptic symptoms were assessed using an 8-item, 5-point Likert scale at baseline and 4 weeks after completion of therapy. Each item was scored from 1 (no symptom) to 5 (very severe), yielding a total score ranging from 8 to 40. Lower scores indicated fewer symptoms. Improvement was defined as a reduction in total symptom score from baseline |
| Adverse Events | During therapy and up to 4 weeks after therapy completion | Incidence and type of treatment-related adverse events reported during and up to 4 weeks after completion of therapy. |
| Compliance to Therapy | End of therapy (14 days) | Proportion of participants who complete the prescribed 14-day therapy as per protocol. |
Countries
Bangladesh
Contacts
CONTACTSyeda Mubashsharah Mahfuz, MBBS
CONTACTMd. Ahid Iqbal Khokan, MBBS, MD
PRINCIPAL_INVESTIGATORSyeda Mubashsharah Mahfuz, MBBS
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Outcome results
None listed