Treatment of resistant Helicobacter pylori infection using vonoprazan-based triple therapy in Egypt

Vonoprazan-Based Triple Therapy for Helicobacter pylori Resistant to First-Line Regimens: A Guideline-Compliant 14-Day Multicenter Study in Egypt

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202505820765765

Enrollment

300

Registered

2025-05-08

Start date

2023-01-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System

Interventions

Vonoprazan triple therapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age =18 years Confirmed H. pylori infection (positive monoclonal stool antigen test AND 13C-urea breath test) Dual antibiotic resistance (clarithromycin MIC >0.5 mg/L AND levofloxacin MIC >1 mg/L via E-test) Prior failure of =1 first-line H. pylori regimen (clarithromycin- or levofloxacin-based) Endoscopic confirmation (with histopathology if non-invasive tests discordant) Willingness to adhere to protocol (documented consent and commitment to follow-up)

Exclusion criteria

Exclusion criteria: Known hypersensitivity to vonoprazan, amoxicillin, or metronidazole Severe comorbidities: Decompensated liver disease (Child-Pugh B/C) Advanced CKD (eGFR <30 mL/min by CKD-EPI) Active malignancies Pregnancy or lactation Recent antibiotic use (within 4 weeks) Recent PPI use (within 4 weeks) History of upper GI surgery (e.g., gastrectomy, vagotomy) Conditions affecting acid secretion (e.g., Zollinger-Ellison syndrome) Active substance abuse disorders (including alcohol dependence)

Design outcomes

Primary

Measure	Time frame
"H. pylori eradication rate" Definition: Successful eradication confirmed by negative monoclonal stool antigen test at 4 weeks and 3 months post-treatment (per Maastricht VI guidelines). Metric: Per-protocol (85%) and intention-to-treat (82%) rates.	—

Secondary

Measure	Time frame
Symptom improvement Metric: Reduction in GSRS scores (e.g., abdominal pain decreased from 79% to 7%). Safety/tolerability Metric: Adverse event rates (16% overall, 4% Grade 3). Endoscopic/histologic changes Metric: Sydney System scores pre/post-treatment. Laboratory parameter improvements Metric: Hemoglobin (11.3 ? 14 g/dL), WBC (10.9 ? 7.2 ×10³/µL). Quality of life (SF-36 scores) Metric: Improvement across all domains (e.g., Physical Functioning: 45.2 ? 75.6).	—

Measure

Time frame

Symptom improvement Metric: Reduction in GSRS scores (e.g., abdominal pain decreased from 79% to 7%). Safety/tolerability Metric: Adverse event rates (16% overall, 4% Grade 3). Endoscopic/histologic changes Metric: Sydney System scores pre/post-treatment. Laboratory parameter improvements Metric: Hemoglobin (11.3 ? 14 g/dL), WBC (10.9 ? 7.2 ×10³/µL). Quality of life (SF-36 scores) Metric: Improvement across all domains (e.g., Physical Functioning: 45.2 ? 75.6).

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Countries

Egypt

Contacts

Public ContactAtteyat Semeya

Lectuer

semeyaatteyat@gmail.com00201002719185

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026