Status:
RECRUITING
VA Dual Sequential Therapy
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
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 pr...
Detailed Description
Helicobacter pylori (HP) is a Gram-negative, spiral-shaped, microaerophilic bacterium that colonizes the gastric mucosa. HP infection is a key pathogenic factor for peptic ulcers and chronic active ga...
Eligibility Criteria
Inclusion
- Aged 18-70 years, gender unrestricted.
- Chronic gastritis patients with Helicobacter pylori positivity: (1) Helicobacter pylori positive is defined as a positive result on a carbon-13 or carbon-14 breath test within one month prior to enrollment; (2) Chronic gastritis is defined as a diagnosis based on gastroscopy within six months prior to enrollment.
- No previous Helicobacter pylori eradication therapy.
- Agree to participate in the trial and sign the informed consent form
Exclusion
- Allergy to any of the drugs used in this clinical trial.
- Previously received H. pylori eradication treatment.
- Receiving Potassium-competitive acid blocker (P-CAB), proton pump inhibitor (PPI), H2 receptor antagonist, antibiotics, bismuth, probiotic preparations 4 weeks before initiating study treatment.
- Use of non-steroidal anti-inflammatory drugs (NSAIDs), adrenal corticosteroids, or anticoagulants during the study period.
- Pregnant or lactating women, or patients planning to conceive during the study period.
- Patients with hepatic or renal dysfunction, or those with severe concomitant diseases that may affect the evaluation of this study, such as heart disease, lung disease, liver disease, kidney disease, metabolic disorders, mental illnesses, malignant tumors, etc..
- Gastroscopy findings indicating conditions other than gastritis, such as reflux esophagitis, which require continued use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H2 receptor antagonists, or bismuth after Helicobacter pylori eradication.
- Patients with a history of gastric surgery.
- Patients who are unable to accurately express their symptoms, such as those with psychiatric disorders or severe neurosis, and are unable to cooperate with the trial.
- Patients who have participated in other drug studies within 3 months before using the investigational drug.
- Other conditions deemed by the investigator as unsuitable for participation in this trial.
Key Trial Info
Start Date :
April 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT06929962
Start Date
April 24 2025
End Date
December 31 2026
Last Update
May 20 2025
Active Locations (1)
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1
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China, 210029