HELICOBACTER PYLORI INFECTIONS
Conditions
Brief summary
1. This study aims to compare the efficacy of empirical vonoprazan-based therapy versus susceptibility-guided vonoprazan-based therapy for third-line eradication of H. pylori. 2. We also plan to explore the impact of eradication therapy on gut microbiota, fecal antibiotic resistance, and metabolic parameters before and after treatment.
Detailed description
Methods: * Study design: Open-labeled, randomized controlled trial * Participants: A total of 220 patients who have failed at least two previous H. pylori eradication treatments will be enrolled. Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of levofloxacin, tetracycline, rifabutin, and clarithromycin to guide the selection of antibiotics. Treatment regimens and assignment: Eligible patients will be randomized to receive either one of the treatments (A) Empirical vonoprazan-based therapy or (B) Susceptibility-guided vonoprazan-based therapy Outcome Measurement: Primary End Point: Eradication rate by intention-to-treat analysis. Secondary End Point: 1. Eradication rate by per-protocol analysis; 2. Frequency of adverse effects.
Interventions
DRUGVonoprazan based ET
Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or quadruple therapy
DRUGVonoprazan based SGT
Susceptibility testing guided therapy Based onsusceptibility test:Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin quadruple therapy
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Helicobacter pylori infected individuals who have failed at least two previous eradication therapies. 2. Willing to undergo third-line eradication therapy. 3. Subjects must be 20 years of age or older.
Exclusion criteria
1. History of gastrectomy. 2. Individuals unsuitable for the study medication, such as those with a history of allergy or severe adverse reactions to the study drugs, quinolone or fluoroquinolone antibiotics, or women who are pregnant or breastfeeding. 3. Presence of severe acute or chronic diseases such as renal failure, liver cirrhosis, incurable malignant tumors, or a history of aortic aneurysm or dissection. 4. Patients with chronic hepatitis (AST or ALT \> 100 U/L). 5. Unwillingness to comply with the treatment plan or sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate by intention-to-treat analysis | 6-8 weeks | Eradication rate will be determined by urea breath test at least 6 weeks aftercompletion of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate by per-protocol analysis and Frequency of adverse effects. | 6-8 weeks | Eradication rate will be determined by urea breath test at least 6 weeks aftercompletion of treatment. A standard interview and questionaire will be used to assess the adverse effects. |
Countries
Taiwan
Contacts
Primary ContactMei-Jyh Chen, MD, PhD
Backup ContactYu-Chun Huang
Outcome results
None listed