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

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ClinicalTrials.gov Identifier: NCT06004401
Recruitment Status : Not yet recruiting
First Posted : August 22, 2023
Last Update Posted : August 22, 2023
Sponsor:
Information provided by (Responsible Party):
Wei-Fen Xie, Shanghai Changzheng Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
The Eradication Rate of Helicobacter Pylori Drug: Vonopazan +Amoxicillin Drug: Rabeprazole +colloidal pectin bismuth +Amoxicillin +Clarithromycin Drug: Vonopazan +Minocycline Drug: Rabeprazole +colloidal pectin bismuth +Metronidazole +Clarithromycin Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Observation on the Efficacy of Dual Therapy Based on Vonoprazan in Eradicating Helicobacter Pylori
Estimated Study Start Date : August 20, 2023
Estimated Primary Completion Date : August 31, 2025
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. The eradication rate of Helicobacter pylori [ Time Frame: two years ]
    whether the dual therapy based on vorolaxen has advantages over traditional quadruple therapy in penicillin negative and positive patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

    -

    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.

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Wei-Fen Xie, Head of gastroenterology，Shanghai Changzheng Hospital, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT06004401    
Other Study ID Numbers: CZHX2023.07
First Posted: August 22, 2023    Key Record Dates
Last Update Posted: August 22, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Amoxicillin
Metronidazole
Clarithromycin
Minocycline
Rabeprazole
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
 Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Antacids