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NCT Number: NCT06881524

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. H. pylori eradication rate

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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

A Randomized Controlled Trial of Low-Dose Amoxicillin Dual-Therapy Combined with Licorice and Lotus Root Powder for the Treatment of Helicobacter Pylori Infection

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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