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NCT Number: NCT07439445

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

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.

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Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location status: Recruiting

Location contact

Meng Li

CONTACT

[email protected]

18612034366

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days

Drug

Participants receive vonoprazan 20 mg orally twice daily plus clarithromycin 500 mg orally twice daily for 14 consecutive days.

Primary outcomes

  1. Eradication rate of H. pylori

    Time frame: 4 weeks after the completion of treatment

    H. pylori eradication rate assessed by¹³C-urea breath test at 4 weeks after the completion of treatment.

Secondary outcomes

  1. incidence of adverse reactions

    Time frame: At the end of the 14-day medication period (Day 14)

    The incidence of adverse reactions refers to the proportion of participants who experience any adverse reactions related to the study drugs (vonoprazan and clarithromycin) during the 14-day medication period.

  2. Compliance

    Time frame: At the end of the 14-day medication period (Day 14)

    Medication compliance rate (proportion of participants with good compliance, defined as compliance rate ≥ 80%).

Study contacts

Contact information is provided by the study sponsor or research team.

Meng Li

CONTACT

[email protected]

18612034366

Weihong Wang, MD, PhD

CONTACT

[email protected]

13041171610

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Efficacy and Safety of Simplified Regimen Guided by Fecal Clarithromycin Resistance Gene Detection for First-line Helicobacter Pylori Eradication

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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