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

NCT07439445 | Recruiting DMC

• 1 other identifier: 2026R0051-0002
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• incidence of adverse reactions

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

• Compliance

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

Study Arms (1)

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

Interventions

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.

Experimental

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Clarithromycin

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Weihong Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weihong Wang, MD, PhD

CONTACT

13041171610; wangweihong2581@163.com

Meng Li

CONTACT

18612034366; dr_limeng@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): February 13, 2027
• Study Completion (Estimated): February 13, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)