Rescue Reatment of Helicobacter Pylori Based on Fecal Antimicrobial Resistance Gene Testing

NCT07533422 | Not Yet Recruiting

• 1 other identifier: 2025-1670
• Study Type: interventional
• Target: 531
• Locations: 0 countries
• Sites: N/A

Brief Summary

Helicobacter pylori(H. pylori, Hp) is a major etiological agent in chronic gastritis, peptic ulcer disease, gastric cancer, and gastric MALT lymphoma. Guideline recommend antimicrobial susceptibility testing following initial treatment failure to guide personalized therapy and improve eradication rates. However, conventional susceptibility testing faces two major limitations: 1) reliance on invasive endoscopic biopsy for tissue acquisition, and 2) dependency on bacterial culture, which is complex and time-consuming. Fecal-based antimicrobial resistance gene testing overcomes these barriers, offering distinct advantages of being non-invasive, rapid and accurate, thereby improving patient compliance. This study aims to elucidate the diagnostic value of fecal nucleic acid testing for H. pyloriinfection and to evaluate the eradication rate and safety of tailored triple therapy regimens selected based on fecal resistance gene profiles.

Conditions

HELICOBACTER PYLORI INFECTIONS; Rescue Therapy for Helicobacter Pylori

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate

  From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (1)

• Adverse effect of the treatment

  From enrollment to the end of treatment at 6 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: Personalized treatment based on the results of fecal antimicrobial resistance gene testing

Control group

ACTIVE COMPARATOR

Drug: Conventional Quadruple Therapy

Interventions

Personalized treatment based on the results of fecal antimicrobial resistance gene testing DRUG

Personalized treatment: Patients sensitive to clarithromycin are assigned to the Clarithromycin Group (receiving a regimen of vonoprazan, amoxicillin, and clarithromycin); Patients resistant to clarithromycin but sensitive to levofloxacin are assigned to the Levofloxacin Group (receiving vonoprazan, amoxicillin, and levofloxacin); Patients resistant to both clarithromycin and levofloxacin are assigned to the Tetracycline Group (receiving vonoprazan, amoxicillin, and tetracycline). The treatment duration for all groups is 10 days. The specific dosages and administration methods are as follows: Vonoprazan: 20 mg, twice daily (BID) Amoxicillin: 1.0 g, twice daily (BID) Clarithromycin: 0.5 g, twice daily (BID) Levofloxacin: 0.5 g, once daily (QD) Tetracycline: 0.5 g, three times daily (TID)

Experimental group

Conventional Quadruple Therapy DRUG

Conventional Quadruple Therapy： Vonoprazan 20mg BID; Colloidal Bismuth Pectin 220mg BID; Amoxicillin 1.0g BID; tetracycline 0.5g TID. Treatment duration: 14 days.

Control group

Eligibility Criteria

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

You may qualify if:

• ① Age 18-70 years;
• Patients with Hp-positive chronic gastritis who have failed initial treatment, as confirmed by urea breath test or endoscopic biopsy;
• No use of PPIs, H2-receptor antagonists, antibiotics, or bismuth agents within 4 weeks;
• History of having received one previous, standardized Hp eradication therapy.

You may not qualify if:

• ① Use of antibiotics, bismuth agents within 4 weeks prior to treatment, or use of PPIs or H₂-receptor antagonists within 2 weeks prior to treatment;
• History of gastric or duodenal surgery;
• Concurrent presence of other serious conditions such as cardiac, hepatic, or renal dysfunction, malignant tumors, or other severe internal diseases;
• Allergy to any component of the study medications; ⑤ Pregnant or breastfeeding women; ⑥ Participation in other drug studies within 3 months prior to treatment; ⑦ Patients unable to accurately express their complaints or cooperate with the study investigators.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 16, 2026
• Study Start (Estimated): May 12, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-03