Fecal Molecular Susceptibility-guided Hp First-line Therapy

ConditionHELICOBACTER PYLORI INFECTIONS

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShanghai Zhongshan Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

13C-urea breath test (13C-UBT) and fecal HP nucleic acid detection confirming Helicobacter pylori (Hp) infection.

Not previously eradicated HP

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

544 Participants

are divided into 2 treatment groups

Group A: 7-dayExperimental treatment 1 intervention

Group B: 14-dayActive comparator 1 intervention

Trial outcomes

Primary outcomes

Eradication rate of Helicobacter pylori

Eradication of Helicobacter pylori was defined as negative result of urea breath test (\<4‰ cut-off value)

Time frame

4-8 weeks after treatment

Secondary outcomes

Frequency of adverse events

Any possible adverse events during the treatment period were recorded.

Time frame

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.

Time frame

Throughout the treatment period, up to 2 weeks

Other outcomes

Average cost of each group

Average medical cost related to therapy and followup in each group

Time frame

Throughout the treatment period, up to 2 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Zhongshan Hospital

Lead sponsor

Source ClinicalTrials.gov

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