Fecal Molecular Susceptibility-guided Hp Rescue Therapy

Clinical Efficacy and Health Economic Evaluation of Fecal Molecular Susceptibility-guided Therapy for Helicobacter Pylori Infection Rescue Treatment: Multicenter Randomized Controlled Study

The goal of this clinical trial is to evaluate the eradication efficacy and health economic benefits of individualized regimens guided by fecal molecular susceptibility testing with 7-day and 14-day courses in the rescue treatment of Helicobacter pylori infection. The main questions it aims to answer are:

1. What is the H. pylori eradication rate of the 7-day versus 14-day individualized regimens?
2. What are the safety, adherence, and cost-effectiveness of the 7-day versus 14-day individualized regimens? Researchers will compare the 7-day course group and the 14-day course group to see if the 7-day course is non-inferior to the 14-day course in terms of eradication rate.

Participants will:

1. Undergo fecal H. pylori drug resistance gene testing
2. Receive randomized assignment to either 7-day or 14-day individualized treatment based on drug susceptibility results
3. Complete follow-up visits at 1 week and 4-8 weeks after stopping treatment for adverse event monitoring and 13C-urea breath test

Study Overview

• Status: Not yet recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: 7-day fecal molecular susceptibility-guided therapy; Drug: 14-day fecal molecular susceptibility-guided therapy

• Study Type: Interventional
• Enrollment (Estimated): 290
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qi Chen, MD; Phone Number: 86-17811921405; Email: chenqimd@163.com

Study Locations

• China
  • Shanghai, China
    • Zhongshan Hospital, Fudan University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Renji Hospital, School of Medicine, Shanghai Jiaotong University
    • Shanghai, Shanghai Municipality, China
      • Shanghai Jiangong Hospitail.
    • Shanghai, Shanghai Municipality, China
      • Shanghai Tenth People Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Voluntarily participate in this clinical study; fully understand, be informed about this study, and sign the Informed Consent Form (ICF).
2. Age between 18 and 75 years (inclusive) on the day of signing the ICF.
3. 13C-urea breath test (13C-UBT) and fecal HP nucleic acid detection confirming Helicobacter pylori (Hp) infection.
4. previously eradicated HP

Exclusion Criteria:

1. Individuals with a known allergy to the medication.
2. Patients with severe cardiovascular, pulmonary, renal, hepatic, hematologic, neurologic, endocrine, or psychiatric disorders;
3. Participants or guardians who refuse to enroll;
4. Alcohol and/or drug abuse (dependence or addiction) or individuals judged by the physician to have poor compliance;
5. Use of antibiotics, bismuth-containing drugs, PPIs, or traditional Chinese medicines within 4 weeks before treatment;
6. Pregnant or lactating women;
7. Any condition deemed by the investigator to be unsuitable for enrollment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 7-day; 7-day fecal molecular susceptibility-guided therapy	Drug: 7-day fecal molecular susceptibility-guided therapy; This intervention involves performing polymerase chain reaction (PCR)-based detection of Helicobacter pylori drug resistance genes (including clarithromycin, levofloxacin) from fecal samples. Based on the susceptibility results and penicillin-allergic test, a tailored 7-day triple or quadruple therapy regimen is prescribed, including Tegoprazan , Amoxicillin, Clarithromycin, Levofloxacin, Bismuth Potassium Citrate, Metronidazole, Doxycycline or Minocycline.
Active Comparator: 14-day; 14-day fecal molecular susceptibility-guided therapy	Drug: 14-day fecal molecular susceptibility-guided therapy; This intervention involves performing polymerase chain reaction (PCR)-based detection of Helicobacter pylori drug resistance genes (including clarithromycin, levofloxacin) from fecal samples. Based on the susceptibility results and penicillin-allergic test, a tailored 14-day triple or quadruple therapy regimen is prescribed, including Tegoprazan , Amoxicillin, Clarithromycin, Levofloxacin, Bismuth Potassium Citrate, Metronidazole, Doxycycline or Minocycline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate of Helicobacter pylori	Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value)	4-8 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events	Any possible adverse events during the treatment period were recorded.	Throughout the treatment period, up to 2 weeks
Adherence rate	The proportion of subjects with good adherence. Good adherence was defined as that subjects took more than 80% of the total medication.	Throughout the treatment period, up to 2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average cost of each group	Average medical cost related to therapy and followup in each group	Throughout the treatment period, up to 2 weeks

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Investigators: Principal Investigator: Hong Gao, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Helicobacter pylori
• Other Study ID Numbers: B2026-013-2

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