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

NCT ID: NCT06881524

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 374 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-08-01

Brief Summary

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.

Detailed Description

Helicobacter pylori (H. pylori, Hp) is closely associated with chronic gastritis, peptic ulcers, gastric cancer and is classified as a Group I carcinogen. In recent years, the increasing prevalence of 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. Our province is considered a high-resistance area for clarithromycin and other antibiotics.

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. However, the role of licorice in Hp infection treatment remains to be confirmed through clinical randomized controlled trials (RCTs). Therefore, 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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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 group receiving high-dose amoxicillin

Group Type: ACTIVE_COMPARATOR

First line high-dose amoxicillin

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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 group receiving high-dose amoxicillin

Group Type: ACTIVE_COMPARATOR

Rescue high-dose amoxicillin

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

First line high-dose amoxicillin

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Rescue high-dose amoxicillin

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Age 18-70 years, regardless of sex; Positive for Helicobacter pylori (Hp); No use of proton pump inhibitors (PPIs), H2-receptor antagonists, antibiotics, or bismuth compounds within the past 4 weeks;

Exclusion Criteria

A history of gastric or duodenal surgery; Presence of other severe comorbidities, including significant cardiac, hepatic, or renal dysfunction, malignancies, or other serious medical conditions; Allergy to any component of the investigational drug; Pregnant or breastfeeding women; Participation in another drug study within 3 months prior to enrollment in this study; Inability of the patient to accurately describe their symptoms or to comply with the requirements of this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2024-0943

Identifier Type: -

Identifier Source: org_study_id