Actively Recruiting
VA Dual Sequential Therapy
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-05-20
600
Participants Needed
1
Research Sites
88 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sequential therapy for Hp was first introduced by Zullo et al. in 2000 and consists of two phases: the first phase involves proton pump inhibitors with one antibiotic, and the second phase involves proton pump inhibitors with two antibiotics. Based on this, the investigators propose a modified sequential therapy, where the first phase uses vonoprazan combined with amoxicillin, and the second phase increases the amoxicillin dosage, forming a high-dose amoxicillin regimen. This new treatment strategy combines the staged nature of sequential therapy with the advantages of high-dose dual therapy, gradually increasing the drug dosage to help patients adapt and reduce side effects (such as nausea, vomiting, and diarrhea), thereby improving patient tolerance. The primary aim of this study is to compare the vonoprazan combined with high-dose amoxicillin sequential therapy with standard dual therapy (14-day regimen) in terms of Hp eradication rates, efficacy, side effect incidence, and patient compliance, to evaluate its improved effectiveness. Additionally, the study will explore the impact of a shortened treatment duration on the modified dual sequential therapy's efficacy for Hp infection. Eligible participants in this study will be randomly assigned to one of the following three treatment groups based on a pre-generated randomization sequence: Control Group: Vonoprazan combined with high-dose amoxicillin dual therapy for 14 days (VADT-14): Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily. Experimental Group 1: Vonoprazan combined with amoxicillin dual sequential therapy for 14 days (VAST-14): Days 1 to 7: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 8 to 14: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily. Experimental Group 2: Vonoprazan combined with amoxicillin dual sequential therapy for 10 days (VAST-10): Days 1 to 5: Vonoprazan 20mg twice daily + Amoxicillin 1g twice daily. Days 6 to 10: Vonoprazan 20mg twice daily + Amoxicillin 1g three times daily.
CONDITIONS
Official Title
VA Dual Sequential Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years, any gender
- Diagnosed with chronic gastritis and positive for Helicobacter pylori within one month before enrollment
- No previous treatment to eradicate Helicobacter pylori
- Willing to participate and sign informed consent
You will not qualify if you...
- Allergy to any drugs used in this trial
- Prior Helicobacter pylori eradication treatment
- Use of certain acid blockers, antibiotics, bismuth, or probiotics within 4 weeks before treatment
- Use of NSAIDs, corticosteroids, or anticoagulants during the study
- Pregnant, breastfeeding, or planning pregnancy during the study
- Severe liver, kidney, heart, lung, metabolic, mental, or cancer conditions
- Gastroscopy showing conditions needing ongoing acid blocker treatment besides gastritis
- History of gastric surgery
- Unable to communicate symptoms accurately due to psychiatric or neurological issues
- Participation in other drug studies within 3 months before this trial
- Any other condition judged unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029
Actively Recruiting
Research Team
F
Feng Ye, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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