Keverprazan Combined with Amoxicillin for the Treatment of Helicobacter Pylori
Status:
NOT_YET_RECRUITING
Trial end date:
2025-09-01
Target enrollment:
Participant gender:
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 and any adverse drug reactions that occur on Days 714 and 1 month after stopping the medication;
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.
Phase:
NA
Details
Lead Sponsor:
Key Laboratory for Gastrointestinal Diseases of Gansu Province