CompletedNot Applicable

Keverprazan Combined With Amoxicillin for the Treatment of Helicobacter Pylori

China264 participantsStarted 2025-03-15

Plain-language summary

The objective of this clinical trial is to determine whether the interventional behavioral drug Keverprazan in combined with amoxicillin, is effective in treating initial Helicobacter pylori infections in adults and to assess the safety of Keverprazan in the treatment of Helicobacter pylori. The primary questions it aims to address are: 1. What is the eradication rate of Keverprazan in individuals with the first-time H. pylori infection? 2. What adverse effects do participants experience while taking the drug Keverprazan? 3. To clarify the microecological changes of Keverprazan on the intestinal tract. The researchers will compare the experimental group receiving Keverprazan in combination with amoxicillin dual therapy to the control group receiving Esomeprazole in combination with amoxicillin dual therapy to assess the efficacy and safety of Keverprazan in treating the primary population infected with Helicobacter pylori. Participants will: 1. Take Keverprazan, esomeprazole, and amoxicillin daily for 14 days; 2. Researchers will record participants' medication adherence on days 7 and 14, as well as any adverse drug reactions; 3. Participants will undergo a urea breath test one month after discontinuing the medication, and the researchers will record the eradication rate. 4. 20 Participants in the experimental group and the control group were randomly selected to collect stool for examination 1 month before and 1 month after treatment.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria * 1)18\~65 years old, gender is not limited; * 2\) H. pylori infection was diagnosed by urea breath test; * 3\) Did not receive H. pylori eradication therapy; * 4\) Informed and consented to participate in this study. Exclusion Criteria: * 1\) Have serious systemic diseases, major organs such as heart, lung, brain diseases, liver and kidney insufficiency, malignant tumors or other diseases; * 2\) Active peptic ulcer with bleeding, perforation, obstruction, cancer and other complications; And subjects with a past or current history of Zolling-Ellison syndrome's disorders; * 3\) Allergic history of penicillin and regimen related drugs; * 4\) Excessive acid-suppressing drugs, such as proton pump inhibitors, potassium competitive acid blockers, histamine H2 receptor antagonists, etc. were used within 2 weeks before enrollment, or antibiotics were used 4 weeks before enrollment; * 5\) Pregnant or lactating women; * 6\) Other participants were deemed unsuitable by the researchers.

What they're measuring

Post-treatment eradication rate of primary treatment participants

Timeframe: up to 2 months

Trial details

NCT IDNCT06851468

SponsorKey Laboratory for Gastrointestinal Diseases of Gansu Province

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-30