Recruiting PHASE4 Helicobacter Pylori Infection

New treatment option for Helicobacter Pylori Infection

Official title VA Dual Sequential Therapy

ClinicalTrials.gov ID: NCT06929962

What this study is testing

What is Vonoprazan and Amoxicillin for the first 7 days?

Vonoprazan and Amoxicillin for the first 7 days is an investigational medicine, given as an once-daily, being studied as a potential treatment for helicobacter pylori infection.

Also referred to as L-VA-7.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Sequential therapy for Hp was first introduced by Zullo et al. in 2000 and consists of two phases: the first phase involves proton pump inhibitors with one antibiotic, and the second phase involves proton pump inhibitors with two antibiotics.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 70

You may be able to join if

  • Aged 18-70 years, gender unrestricted.
  • Chronic gastritis patients with Helicobacter pylori positivity: (1) Helicobacter pylori positive is defined as a positive result on a carbon-13 or...
  • No previous Helicobacter pylori eradication therapy.
  • Agree to participate in the trial and sign the informed consent form

You likely can't join if

  • Allergy to any of the drugs used in this clinical trial.
  • Previously received H. pylori eradication treatment.
  • Receiving Potassium-competitive acid blocker (P-CAB), proton pump inhibitor (PPI), H2 receptor antagonist, antibiotics, bismuth, probiotic...
  • Use of non-steroidal anti-inflammatory drugs (NSAIDs), adrenal corticosteroids, or anticoagulants during the study period.
  • Pregnant or lactating women, or patients planning to conceive during the study period.
  • Patients with hepatic or renal dysfunction, or those with severe concomitant diseases that may affect the evaluation of this study, such as heart...
See the full eligibility criteria
Who can join
  • Aged 18-70 years, gender unrestricted.
  • Chronic gastritis patients with Helicobacter pylori positivity: (1) Helicobacter pylori positive is defined as a positive result on a carbon-13 or carbon-14 breath test within one month prior to enrollment; (2) Chronic...
  • No previous Helicobacter pylori eradication therapy.
  • Agree to participate in the trial and sign the informed consent form
What rules you out
  • Allergy to any of the drugs used in this clinical trial.
  • Previously received H. pylori eradication treatment.
  • Receiving Potassium-competitive acid blocker (P-CAB), proton pump inhibitor (PPI), H2 receptor antagonist, antibiotics, bismuth, probiotic preparations 4 weeks before initiating study treatment.
  • Use of non-steroidal anti-inflammatory drugs (NSAIDs), adrenal corticosteroids, or anticoagulants during the study period.
  • Pregnant or lactating women, or patients planning to conceive during the study period.
  • Patients with hepatic or renal dysfunction, or those with severe concomitant diseases that may affect the evaluation of this study, such as heart disease, lung disease, liver disease, kidney disease, metabolic...
  • Gastroscopy findings indicating conditions other than gastritis, such as reflux esophagitis, which require continued use of potassium-competitive acid blockers (P-CABs), proton pump inhibitors (PPIs), H2 receptor...
  • Patients with a history of gastric surgery.
  • Patients who are unable to accurately express their symptoms, such as those with psychiatric disorders or severe neurosis, and are unable to cooperate with the trial.
  • Patients who have participated in other drug studies within 3 months before using the investigational drug.
  • Other conditions deemed by the investigator as unsuitable for participation in this trial.

The study team makes the final eligibility decision.

Where it's taking place

  • Nanjing, Jiangsu, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.