Fecal Molecular Susceptibility-guided Hp First-line Therapy

NCT07405684 | Not Yet Recruiting Phase 4

• 1 other identifier: B2026-013-1
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 4

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

Conditions

HELICOBACTER PYLORI INFECTIONS

Keywords

Helicobacter pylori

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Frequency of adverse events

  Throughout the treatment period, up to 2 weeks

• Adherence rate

  Throughout the treatment period, up to 2 weeks

Other Outcomes (1)

• Average cost of each group

  Throughout the treatment period, up to 2 weeks

Study Arms (2)

7-day

EXPERIMENTAL

Drug: 7-day fecal molecular susceptibility-guided therapy

14-day

ACTIVE COMPARATOR

Drug: 14-day fecal molecular susceptibility-guided therapy

Interventions

7-day fecal molecular susceptibility-guided therapy DRUG

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.

7-day

14-day fecal molecular susceptibility-guided therapy DRUG

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, a tailored 14-day triple or quadruple therapy regimen is prescribed, including Tegoprazan , Amoxicillin, Clarithromycin, Levofloxacin, Bismuth Potassium Citrate, Metronidazole, Doxycycline or Minocycline.

14-day

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in this clinical study; fully understand, be informed about this study, and sign the Informed Consent Form (ICF).
• Age between 18 and 75 years (inclusive) on the day of signing the ICF.
• C-urea breath test (13C-UBT) and fecal HP nucleic acid detection confirming Helicobacter pylori (Hp) infection.
• Not previously eradicated HP

You may not qualify if:

• Individuals with a known allergy to the medication.
• Patients with severe cardiovascular, pulmonary, renal, hepatic, hematologic, neurologic, endocrine, or psychiatric disorders;
• Participants or guardians who refuse to enroll;
• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (4)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200000, China

Location

Shanghai Jiangong Hospitail.

Shanghai, Shanghai Municipality, China

Location

Shanghai Tenth People Hospital

Shanghai, Shanghai Municipality, China

Location

Zhongshan Hospital, Fudan University

Shanghai, China

Location

Central Study Contacts

Qi Chen

CONTACT

86-17811921405; chenqimd@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 12, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)