RecruitingNot Applicable

Simplified Dual Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line H. Pylori Eradication

China70 participantsStarted 2026-04-25

Plain-language summary

To investigate the efficacy, safety, and compliance of a simplified strategy using vonoprazan plus clarithromycin for first-line treatment in patients with Helicobacter pylori infection, among those infected with strains without clarithromycin resistance gene mutations based on fecal clarithromycin resistance gene detection.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Aged 18-70 years;
✓. Positive results for both ¹³C-urea breath test (¹³C-UBT) and fecal polymerase chain reaction (PCR), confirming Helicobacter pylori infection, with a clinical indication for H. pylori eradication as judged by the physician;
✓. Treatment-naïve individuals with no prior history of H. pylori eradication therapy.

Exclusion criteria

✕. Pregnant or lactating women
✕. Patients with a history of allergy to any drugs used in the eradication regimen
✕. Patients with severe systemic diseases or malignant tumors
✕. History of gastric resection surgery
✕. Recent use of antibiotics or bismuth salts (within 4 weeks), H₂-receptor antagonists, proton pump inhibitors (PPIs), or Potassium-competitive acid blockers(P-CABs) (within 2 weeks).

What they're measuring

Eradication rate of H. pylori

Timeframe: 4 weeks after the completion of treatment

Trial details

NCT IDNCT07439445

SponsorPeking University First Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-13

Contact for this trial

Weihong Wang, MD, PhD

13041171610 wangweihong2581@163.com

View on ClinicalTrials.gov More Helicobacter Pylori Infection trials