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

Not Applicable

Not yet recruiting

• Conditions: HELICOBACTER PYLORI INFECTIONS
• Interventions: Drug: First-line licorice and lotus root powder combined with low-dose amoxicillin; Drug: First line high-dose amoxicillin; Drug: Rescue licorice and lotus root powder combined with low-dose amoxicillin; Drug: Rescue high-dose amoxicillin

• Registration Number: NCT06881524
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Study Start: 2025-04-01
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 374

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
First-line group receiving licorice and lotus root powder combined with low-dose amoxicillin	First-line licorice and lotus root powder combined with low-dose amoxicillin	First-line group receiving licorice and lotus root powder combined with low-dose amoxicillin
First-line group receiving high-dose amoxicillin	First line high-dose amoxicillin	-
Rescue group receiving licorice and lotus root powder combined with low-dose amoxicillin	Rescue licorice and lotus root powder combined with low-dose amoxicillin	-
Rescue group receiving high-dose amoxicillin	Rescue high-dose amoxicillin	-

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate	From enrollment to the end of treatment at 6 weeks