A Phase 4 interventional study of Linalarose Glutarate and Bismuth Quadruple Test in HELICOBACTER PYLORI INFECTIONS, sponsored by Yongquan Shi. Recruiting at 24 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Yongquan Shi · Phase 4, Interventional, and Treatment
This clinical trial aims to compare the efficacy of the dual therapy regimen of linralase glutarate capsules and amoxicillin versus the quadruple therapy regimen containing bismuth for the first-line eradication of Helicobacter pylori infection. The primary questions this trial aims to address include: 1. Whether the linalarenate glutarate capsule-amoxicillin dual-drug regimen is non-inferior to the bismuth-containing quadruple therapy, while simultaneously evaluating patient adherence and the incidence of adverse events in both treatment groups. Participants will: 1. Treatment group: Linaralate Glutarate Capsules (50 mg bid) + Amoxicillin (1 g tid), for a 14-day treatment course. 2. Control group: Esomeprazole 20 mg, twice daily (bid) + clarithromycin 0.5 g, twice daily (bid) + amoxicillin 1 g, twice daily (bid) + colloidal bismuth subcitrate 200 mg, twice daily (bid), for a 14-day treatment course. The primary endpoint is the Helicobacter pylori eradication rate 4 weeks after discontinuation of treatment.
Yongquan Shi is the lead sponsor of 9 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Glutaric acid linalaric acid ester capsules (50 mg bid) + amoxicillin (1 g tid), for a 14-day course.
Drug: Linalarose Glutarate
Esomeprazole 20 mg, twice daily (bid) + clarithromycin 0.5 g, twice daily (bid) + amoxicillin 1 g, twice daily (bid) + colloidal bismuth subcitrate 200 mg, twice daily (bid), for a 14-day treatment course.
Drug: Bismuth Quadruple Test
Glutaric acid linalaric acid ester capsules (50 mg bid) + amoxicillin (1 g tid), for a 14-day course.
Esomeprazole 20 mg, twice daily (bid) + clarithromycin 0.5 g, twice daily (bid) + amoxicillin 1 g, twice daily (bid) + colloidal bismuth subcitrate 200 mg, twice daily (bid), for a 14-day treatment course.
Helicobacter pylori eradication
The primary end point of this study is H.pylori eradication#established by negative \[13C\] urea breath test #DOB value below 3.9#28 days after the end of eradication
Time frame: 28 days after treatment
adverse events
Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain.
Time frame: 14 days of treatment, and 28 days after treatment
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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