The Observation on the Efficacy of Dual Therapy Based on Vonoprazan in Eradicating Helicobacter Pylori

Helicobacter pylori（Hp）is listed as a Class 1 carcinogen by the International Agency for Research of Cancer (IARC), Eradicating Hp can significantly reduce the risk of gastric cancer. In recent years, the resistance rate of Hp to antibiotics, especially Clarithromycin and Metronidazole, has increased, leading to the gradual reduction of the eradication rate . In addition, PPI is mainly metabolized by CYP2C19 in the body, and the genetic polymorphism of this enzyme activity in the population results in significant individual differences in the acid suppression effect of PPI; At the same time, PPI will affect the metabolism of other drugs by affecting the activity of CYP2C19 in the liver.

Potassium ion competitive acid blockers (P-CABs) are a new type of antacids, and vonoprazan is a representative of this class of drugs. Compared to traditional proton pump inhibitors, it has higher selectivity towards proton pumps, stronger acid inhibition effect, faster onset time , longer sustained acid inhibition time, and less influence from food consumption. Therefore, it can effectively eliminate Helicobacter pylori . In recent years, Vonoprazan has been widely used in the eradication treatment of Hp . Vonoprazan can inhibit gastric acid secretion more strongly and persistently, therefore, eradication plans based on vonoprazan are expected to improve the eradication rate of Hp.

Related studies have shown that compared to traditional proton pump inhibitors, vonoprazan has a more significant therapeutic effect and higher safety in the treatment of Helicobacter pylori positive peptic ulcers due to its unique mechanism of action..In recent years, there have been reports of successful eradication of multi drug resistant Hp retreated patients with Semisynthesis tetracycline. Some domestic scholars are also gradually trying to use Semisynthesis tetracycline to eradicate Hp infection. Minocycline is a Semisynthesis tetracycline. The drug sensitivity test in vitro showed that the resistance rate of Hp to Minocycline was low , suggesting that Minocycline may have a better effect on eradicating Hp.

Therefore, the investigators further carried out a prospective single center clinical study and set up a penicillin negative group. One month after treatment, 13C carbon breath test was performed to check the efficacy, in order to explore the efficacy of the combination therapy based on vonoprazan in eradicating Hp, especially whether it is a good choice for penicillin allergy.

Study Overview

• Status: Not yet recruiting
• Conditions: The Eradication Rate of Helicobacter Pylori
• Intervention / Treatment: Drug: Vonopazan +Amoxicillin; Drug: Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin; Drug: Vonopazan +Minocycline; Drug: Rabeprazole +colloidal pectin bismuth +Metronidazole +Clarithromycin

Detailed Description

After one month of treatment, a 13C carbon breath test was conducted to investigate the efficacy of a dual therapy based on vorolaxen in eradicating Hp, especially for those allergic to penicillin.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:•

1. Male or female aged 18-75;
2. Initial treatment patients with Helicobacter pylori infection (positive 13C carbon breath test/positive Hp in gastroscopy pathological biopsy);

3. Not taking antibiotics, bismuth agents, or traditional Chinese medicine with antibacterial effects (Isatis indigotica, berberine, honeysuckle, forsythia suspensa) in the first 4 weeks; I did not take drugs that affect Hp activity such as PPI or H2 receptor antagonists in the first two weeks.

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   Exclusion Criteria:

   • 1）Age<18 years old or>75 years old; 2）Pregnant and lactating women; 3）Patients with severe primary diseases such as cardiovascular, liver, kidney, and hematopoietic systems, as well as mental illness.

     4）History of Drug allergy used in the treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Penicillin negative test group; （Vonopazan 20mg 2//day+Amoxicillin 1.0g 3/day）*14 days	Drug: Vonopazan +Amoxicillin; Vonopazan 20mg 2//day+Amoxicillin
Active Comparator: Penicillin negative contral group; （Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Amoxicillin 1g 2/day+Clarithromycin 500mg 2/day）*14 days	Drug: Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin; Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Amoxicillin 1g 2/day+Clarithromycin 500mg 2/day
Experimental: Penicillin positive test group; （Vonopazan 20mg 2/day+Minocycline 100mg 2/day）*14 days	Drug: Vonopazan +Minocycline; Vonopazan 20mg 2/day+Minocycline 100mg 2/day
Active Comparator: Penicillin positive control group; （Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Metronidazole 0.4g 3/day+Clarithromycin 500mg 2/day）*14 days	Drug: Rabeprazole +colloidal pectin bismuth +Metronidazole +Clarithromycin; Rabeprazole tablets 10mg 2/day+colloidal pectin bismuth 200mg 2/day+Metronidazole 0.4g 3/day+Clarithromycin 500mg 2/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The eradication rate of Helicobacter pylori	whether the dual therapy based on vorolaxen has advantages over traditional quadruple therapy in penicillin negative and positive patients	two years

Collaborators and Investigators

• Sponsor: Shanghai Changzheng Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2023
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Antiprotozoal Agents; Antiparasitic Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Antacids; Metronidazole; Rabeprazole; Amoxicillin; Clarithromycin; Bismuth; Minocycline
• Other Study ID Numbers: CZHX2023.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No