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

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

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weihong Wang, MD, PhD; Phone Number: 13041171610; Email: wangweihong2581@163.com
• Study Contact Backup: Name: Meng Li; Phone Number: 18612034366; Email: dr_limeng@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Meng Li; Phone Number: 18612034366; Email: dr_limeng@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged 18-70 years;
2. 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;
3. Treatment-naïve individuals with no prior history of H. pylori eradication therapy.

Exclusion Criteria:

1. Pregnant or lactating women
2. Patients with a history of allergy to any drugs used in the eradication regimen
3. Patients with severe systemic diseases or malignant tumors
4. History of gastric resection surgery
5. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Vonoprazan 20mg twice a day + clarithromycin 500mg twice a day	Drug: Vonoprazan 20 mg twice daily + clarithromycin 500 mg twice daily for 14 days; Participants receive vonoprazan 20 mg orally twice daily plus clarithromycin 500 mg orally twice daily for 14 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate of H. pylori	H. pylori eradication rate assessed by¹³C-urea breath test at 4 weeks after the completion of treatment.	4 weeks after the completion of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of adverse reactions	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.	At the end of the 14-day medication period (Day 14)
Compliance	Medication compliance rate (proportion of participants with good compliance, defined as compliance rate ≥ 80%).	At the end of the 14-day medication period (Day 14)

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Principal Investigator: Weihong Wang, MD, PhD, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2026
• Primary Completion (Estimated): February 13, 2027
• Study Completion (Estimated): February 13, 2027

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Macrolides; Lactones; Erythromycin; Polyketides; Clarithromycin; 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine
• Other Study ID Numbers: 2026R0051-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No