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Mechanisms of Gut Microbiota in Improving Metabolic Syndrome-Related Parameters Following Helicobacter pylori Eradication.

Mechanisms of Gut Microbiota in Improving Metabolic Syndrome-Related Parameters Following Helicobacter pylori Eradication.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102908
Enrollment
Unknown
Registered
2025-05-21
Start date
2025-04-24
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection combined with metabolic syndrome

Interventions

VA group:vonoprazan-amoxicillin dual therapy
Probiotics Group:vonoprazan-amoxicillin dual therapy combined with probiotics
BBR Group:vonoprazan-amoxicillin dual therapy combined with berberine
Healthy control group:None

Sponsors

Nanjing First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years; 2. Treatment-naïve patients with H. pylori infection confirmed by urea breath test (UBT); 3. Newly diagnosed metabolic syndrome (MS) meeting the diagnostic criteria of the Chinese Diabetes Society (CDS, 2004, China-specific criteria); 4. Voluntary participation in the trial with signed informed consent;

Exclusion criteria

Exclusion criteria: 1. Allergy to study medications (e.g., penicillin, amoxicillin, vonoprazan); 2. Confirmed active peptic ulcer; 3. History of prior H. pylori eradication therapy; 4. Use of medications for metabolic regulation (e.g., glucose-lowering agents, lipid-regulating agents, or weight-loss drugs); 5. Recent use of antibiotics, bismuth-containing agents (within 4 weeks), or histamine H2-receptor antagonists/proton pump inhibitors (within 2 weeks) before study initiation; 6. Use of corticosteroids, nonsteroidal anti-inflammatory drugs (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, or inflammatory bowel disease); 10. Chronic alcoholism; 11. Gastric mucosa-associated lymphoid tissue (MALT) lymphoma or malignant diseases;

Design outcomes

Primary

MeasureTime frame
Multi-Omics Analysis;Helicobacter pylori eradication rate;Metabolic Syndrome Related Parameters;Gut Microbiota Structural Changes;

Countries

China

Contacts

Public ContactWanli Liu

Nanjing First Hospital

18951768998@163.com+86 25 85370998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026