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Low-Dose Amoxicillin Dual-Therapy Combined with Licorice and Lotus Root Powder Helicobacter Pylori Treatment

ConditionHELICOBACTER PYLORI INFECTIONS
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

In recent years, the increasing prevalence of Helicobacter pylori (H. pylori, Hp) resistance has led to a gradual decline in the eradication rate of Hp. The growing resistance to antibiotics, particularly clarithromycin, has severely impacted the efficacy of Hp eradication. Dual-therapy regimen consisting of a proton pump inhibitor (PPI) and amoxicillin can overcome clarithromycin resistance in Hp and is effective for Hp treatment. Vonoprazan, a novel potassium-competitive acid blocker (P-CAB), has a stronger and more sustained inhibitory effect on gastric acid secretion compared to traditional PPIs. Dual-therapy regimens combining P-CABs and high-dose amoxicillin have demonstrated high eradication rates. However, the adverse effects associated with high-dose amoxicillin, such as nephrotoxicity, limit the application of this regimen. Our recent in vitro bacterial experiments and animal studies have shown that licorice, a traditional Chinese herbal medicine that is also used as a food, can inhibit the growth of Hp. This study is designed to compare a licorice-containing treatment regimen with a low-dose amoxicillin dual-therapy regimen in a clinical RCT to explore the efficacy of the former in Hp infection treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • First-line licorice and lotus root powder combined with low-dose amoxicillin

    Drug

    For first-line experimental group, patients would receive vonoprazan 20mg twice daily, amoxicillin 0.75g three times daily for 10 days, licorice and lotus root powder 5.0g twice daily for an additional 6 weeks

  • First line high-dose amoxicillin

    Drug

    For first-line active comparator group, patients would receive vonoprazan 20mg twice daily, amoxicillin 1 g three times daily for 10 days

  • Rescue licorice and lotus root powder combined with low-dose amoxicillin

    Drug

    For rescue experimental group, patients would receive vonoprazan 20mg twice daily, amoxicillin 0.75g three times daily for 10 days, licorice and lotus root powder 5.0g twice daily for an additional 6 weeks

  • Rescue high-dose amoxicillin

    Drug

    For rescue active comparator group, patients would receive vonoprazan 20mg twice daily, amoxicillin 1 g three times daily for 10 days

Treatment groups

374 Participants
are divided into 4 treatment groups
Group A: First-line group receiving licorice and lotus root powder combined with low-dose amoxicillinExperimental treatment 1 intervention
Group B: First-line group receiving high-dose amoxicillinActive comparator 1 intervention
Group C: Rescue group receiving licorice and lotus root powder combined with low-dose amoxicillinExperimental treatment 1 intervention
Group D: Rescue group receiving high-dose amoxicillinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

H. pylori eradication rate

Time frame
From enrollment to the end of treatment at 6 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: