Fecal Molecular Susceptibility-guided Hp Rescue Therapy

NCT07405697 — Phase 4, Not yet recruiting, 290 participants, Shanghai Zhongshan Hospital

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT07405697
Status	Not yet recruiting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	290 (Estimated)
Sponsor	Shanghai Zhongshan Hospital (Other)
Conditions	Helicobacter Pylori Infection
Interventions	7-day fecal molecular susceptibility-guided therapy, 14-day fecal molecular susceptibility-guided therapy (Drug)
Dates	start 2026-02-28 (estimated), primary completion 2027-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2026-02-12, last updated 2026-02-12
Locations	4 sites in China

-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 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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
7-day	Experimental	Drug: 7-day fecal molecular susceptibility-guided therapy	7-day fecal molecular susceptibility-guided therapy
14-day	Active comparator	Drug: 14-day fecal molecular susceptibility-guided therapy	14-day fecal molecular susceptibility-guided therapy

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.
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 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.

+Outcome measures

Primary outcomes

Eradication rate of Helicobacter pylori [4-8 weeks after treatment]: Eradication of Helicobacter pylori was defined as negative result of urea breath test (<4‰ cut-off value)

Secondary outcomes

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

Other outcomes

Average cost of each group [Throughout the treatment period, up to 2 weeks]: Average medical cost related to therapy and followup in each group

+Eligibility

Sex: All, ages: 18 Years to 75 Years

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.

+Locations (4)

Facility	City	Country
Renji Hospital, School of Medicine, Shanghai Jiaotong University	Shanghai, Shanghai Municipality	China
Shanghai Jiangong Hospitail.	Shanghai, Shanghai Municipality	China
Shanghai Tenth People Hospital	Shanghai, Shanghai Municipality	China
Zhongshan Hospital, Fudan University	Shanghai	China

+Investigators

Hong Gao, MD, Principal investigator, Fudan University