NCT06881524

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 374 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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
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
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
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

Timeline

• Start date: 2025-04-01
• Primary completion: 2025-07-01
• Completion: 2025-08-01
• First posted: 2025-03-18
• Last updated: 2025-03-18