Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut M
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 a
| Condition(s) | HELICOBACTER PYLORI INFECTIONS, Metabolic Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | 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 |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Nanjing First Hospital, Nanjing Medical University |
| Locations | Nanjing, Jiangsu, China |
| Start date | 2025-04-17 |
| NCT ID | NCT07306988 |
| Official listing | https://clinicaltrials.gov/study/NCT07306988 |