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New treatment option for HELICOBACTER PYLORI INFECTIONS
Official title Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut Microbiota.
ClinicalTrials.gov ID: NCT07306988
What this study is testing
What is Vonoprazan-Amoxicillin Dual Therapy?
Vonoprazan-Amoxicillin Dual Therapy is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for helicobacter pylori infections.
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
- The Role of Gut Microbiota in the Mechanism of Helicobacter pylori Eradication-Induced Amelioration of Metabolic Syndrome-Related Parameters Study Sponsor: Nanjing First Hospital Principal Investigator: Dr. Wanli Liu Department: Gastroenterology Study Duration: February 2025 - August 2025 Key Information for Patients and Families 1.
- 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 65. Healthy volunteers may be eligible.
You may be able to join if
- For H. pylori-naïve infected patients with newly diagnosed metabolic syndrome (MS):
- Aged 18-65 years;
- Confirmed H. pylori-positive status by urea breath test (UBT), with no prior eradication therapy;
- Newly diagnosed MS according to the Chinese Diabetes Society (CDS, 2004 Chinese criteria) ;
- Voluntarily join the trial and sign informed consent.
You likely can't join if
- Hypersensitivity to study drugs (e.g., penicillin, amoxicillin, vonoprazan);
- Active peptic ulcer confirmed by endoscopy;
- Prior history of H. pylori eradication therapy;
- Use of medications for metabolic regulation (e.g., hypoglycemic agents, lipid-lowering drugs, weight-loss drugs)
- Recent use of antibiotics or bismuth (within 4 weeks) or H2-receptor antagonists/PPIs (within 2 weeks) before enrollment;
- Current use of corticosteroids, NSAIDs, or anticoagulants;
See the full eligibility criteria
- For H. pylori-naïve infected patients with newly diagnosed metabolic syndrome (MS):
- Aged 18-65 years;
- Confirmed H. pylori-positive status by urea breath test (UBT), with no prior eradication therapy;
- Newly diagnosed MS according to the Chinese Diabetes Society (CDS, 2004 Chinese criteria) ;
- Voluntarily join the trial and sign informed consent.
- For H. pylori-negative healthy controls with normal metabolism:
- Aged 18-65 years;
- Confirmed H. pylori-negative status by UBT;
- Normal metabolic parameters (e.g., blood glucose, lipid profile, blood pressure) without MS;
- Voluntarily join the trial and sign informed consent.
- Hypersensitivity to study drugs (e.g., penicillin, amoxicillin, vonoprazan);
- Active peptic ulcer confirmed by endoscopy;
- Prior history of H. pylori eradication therapy;
- Use of medications for metabolic regulation (e.g., hypoglycemic agents, lipid-lowering drugs, weight-loss drugs)
- Recent use of antibiotics or bismuth (within 4 weeks) or H2-receptor antagonists/PPIs (within 2 weeks) before enrollment;
- Current use of corticosteroids, NSAIDs, or anticoagulants;
- History of esophageal or gastric surgery;
- Pregnant or breastfeeding women;
- Severe comorbidities (e.g., hepatic, cardiovascular, pulmonary, renal diseases, inflammatory bowel disease);
- Chronic alcohol abuse (\>40 g/day for men, \>20 g/day for women);
- Malignancies (e.g., gastric mucosa-associated lymphoid tissue [MALT] lymphoma).
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 65 years. Healthy volunteers may be eligible. 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.