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Search / Trial NCT06004401

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

Launched by SHANGHAI CHANGZHENG HOSPITAL · Aug 21, 2023

Trial Information

Current as of November 13, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach using a medication called vonoprazan to help eliminate Helicobacter pylori (Hp), a type of bacteria linked to stomach cancer. The trial aims to see how effective this dual therapy is, especially for patients who are allergic to penicillin. Hp can be hard to treat because it has become resistant to some common antibiotics, but vonoprazan works differently than traditional treatments, providing stronger and longer-lasting acid suppression in the stomach, which may help improve the chances of successfully eliminating the bacteria.

To participate in this trial, individuals must be between 18 and 75 years old and have recently tested positive for Hp. They should not have taken antibiotics or certain other medications that could interfere with the treatment in the weeks leading up to the trial. If enrolled, participants will undergo a breath test one month after starting treatment to check if the Hp has been eradicated. This study is important because it could offer a new and effective option for treating Hp, especially for those with specific allergies or treatment challenges.

Gender

ALL

Eligibility 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.

About Shanghai Changzheng Hospital

Shanghai Changzheng Hospital, affiliated with the Second Military Medical University, is a leading medical institution in China known for its comprehensive clinical services and advanced research capabilities. With a commitment to improving patient outcomes and advancing medical knowledge, the hospital actively engages in clinical trials across various therapeutic areas. Its multidisciplinary team of healthcare professionals collaborates with researchers and industry partners to facilitate innovative studies, ensuring adherence to the highest ethical and regulatory standards. By leveraging its state-of-the-art facilities and expertise, Shanghai Changzheng Hospital aims to contribute significantly to the development of new treatments and therapies that enhance patient care.

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Patients applied

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported