Dual-drug therapy with linlarase glutarate and amoxicillin vs bismuth quadruple therapy for first-line Helicobacter pylori eradication

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, phase 4 trial compares a dual-drug regimen (linlarase glutarate capsules 50 mg twice daily plus amoxicillin 1 g three times daily for 14 days) with a bismuth-containing quadruple regimen (esomeprazole, clarithromycin, amoxicillin, and colloidal bismuth subcitrate, each twice daily for 14 days) in adults with confirmed Helicobacter pylori infection who have not previously received eradication therapy. The primary outcome is eradication of H. pylori at 4 weeks after completing therapy, with secondary considerations including patient adherence and adverse events. Eligible participants are adults 18-70 without prior eradication, who have a confirmed infection and provide informed consent. Key exclusions include drug allergies, recent use of antibiotics or antisecretory medications, prior eradication failure, pregnancy, and certain gastrointestinal conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* (1) Adult patients aged 18-70 years, regardless of gender;
* (2) Patients diagnosed with Helicobacter pylori infection via 13C/14C-UBT;
* (3) Patients who have not previously undergone Helicobacter pylori eradication therapy;
* (4) Patients who have provided informed consent and voluntarily agreed to participate in this study.

Exclusion Criteria:

* (1) Individuals allergic to the study drug;
* (2) Individuals who have taken antibiotics, bismuth-containing agents, probiotics, or traditional Chinese medicines with antibacterial activity within the past 4 weeks;
* (3) Individuals who have taken P-CAB, PPI, or H2 receptor antagonists within the past 2 weeks;
* (4) Individuals with a history of failed Helicobacter pylori eradication therapy;
* (5) Women who are pregnant, breastfeeding, or planning to become pregnant;
* (6) Patients with concomitant peptic ulcers, reflux esophagitis, MALT lymphoma, gastrointestinal malignancies, or those who have undergone esophageal or gastric surgery;
* (7) Patients with severe cardiac, hepatic, pulmonary, or renal diseases, or those with impaired immunity;
* (8) Patients unable to comply with treatment due to alcohol abuse, substance abuse, or severe mental illness;
* (9) Patients requiring treatment with atazanavir, nelfinavir, or rilpivirine.

Where it's running

• Henan Provincial People's Hospital
  Zhengzhou, Henan, China Recruiting
• The First Affiliated Hospital of ZhengzhouUniversity
  Zhengzhou, Henan, China Recruiting
• Second Affiliated Hospital of Xi'an Jiaotong University
  Xi'an, Shaanxi, China Recruiting
• Xijing Hosipital of Digestive Disease
  Xi'an, Shaanxi, China Recruiting
• Wenzhou Central Hospital
  Wenzhou, Zhejiang, China Recruiting
• Xuanwu Hospital, Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yongquan Shi, Ph.D
• Email: von15991351319@163.com
• Phone: 86-029-84771535

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.