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ClinicalTrials.gov ID

NCT07405684

Lead Sponsor

Shanghai Zhongshan HospitalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

544Estimated

Last Update Posted

Feb 12, 2026Actual

Start Date

Feb 28, 2026Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

Official Title

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

Brief Summary

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 first-line 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

• HELICOBACTER PYLORI INFECTIONS

• 7-day fecal molecular susceptibility-guided therapy
• 14-day fecal molecular susceptibility-guided therapy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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. Not 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Shanghai Zhongshan HospitalOTHER

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