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

NCT06881524 | Not Yet Recruiting

• 1 other identifier: 2024-0943
• Study Type: interventional
• Target: 374
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Outcome Measures

Primary Outcomes (1)

• H. pylori eradication rate

  From enrollment to the end of treatment at 6 weeks

Study Arms (4)

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

EXPERIMENTAL

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

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

First-line group receiving high-dose amoxicillin

ACTIVE COMPARATOR

Drug: First line high-dose amoxicillin

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

EXPERIMENTAL

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

Rescue group receiving high-dose amoxicillin

ACTIVE COMPARATOR

Drug: Rescue high-dose amoxicillin

Interventions

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

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

First-line group receiving high-dose amoxicillin

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

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

Rescue group receiving high-dose amoxicillin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: April 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03