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Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut Microbiota.

RecruitingPhase 4Ages 18 Years - 65 YearsAllNanjing First Hospital, Nanjing Medical University
NCT07306988 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. What is this study about? This study aims to understand how treating a common stomach infection caused by Helicobacter pylori (Hp) might improve metabolic health issues like high blood sugar, cholesterol problems, or obesity (collectively called metabolic syndrome). Specifically, it explores whether adding probiotics (good bacteria) or a natural compound called berberine (BBR) to standard Hp treatment can enhance these benefits by improving gut bacteria balance. 2. Who can participate? Patients: Adults aged 18-65 with both Helicobacter pylori infection (co

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📋 Eligibility rules (as published)
Inclusion Criteria: * For H. pylori-naïve infected patients with newly diagnosed metabolic syndrome (MS): 1. Aged 18-65 years; 2. Confirmed H. pylori-positive status by urea breath test (UBT), with no prior eradication therapy; 3. Newly diagnosed MS according to the Chinese Diabetes Society (CDS, 2004 Chinese criteria) ; 4. Voluntarily join the trial and sign informed consent. * For H. pylori-negative healthy controls with normal metabolism: 1. Aged 18-65 years; 2. Confirmed H. pylori-negative status by UBT; 3. Normal metabolic parameters (e.g., blood glucose, lipid profile, blood pressure) without MS; 4. Voluntarily join the trial and sign informed consent. Exclusion Criteria: 1. Hypersensitivity to study drugs (e.g., penicillin, amoxicillin, vonoprazan); 2. Active peptic ulcer confirmed by endoscopy; 3. Prior history of H. pylori eradication therapy; 4. Use of medications for metabolic regulation (e.g., hypoglycemic agents, lipid-lowering drugs, weight-loss drugs) 5. Recent use of antibiotics or bismuth (within 4 weeks) or H2-receptor antagonists/PPIs (within 2 weeks) before enrollment; 6. Current use of corticosteroids, NSAIDs, or anticoagulants; 7. History of esophageal or gastric surgery; 8. Pregnant or breastfeeding women; 9. Severe comorbidities (e.g., hepatic, cardiovascular, pulmonary, renal diseases, inflammatory bowel disease); 10. Chronic alcohol abuse (\>40 g/day for men, \>20 g/day for women); 11. Malignancies (e.g., gastric mucosa-associated lymphoid tissue \[MALT\] lymphoma).
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What it tests

  • Vonoprazan-Amoxicillin Dual Therapy
  • Vonoprazan-Amoxicillin with Bifidobacterium tetravaccae
  • Vonoprazan-Amoxicillin with Berberine
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Where

1 site
Nanjing First Hospital, Nanjing Medical University
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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