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

Plain-language summary

This study examines whether treating Helicobacter pylori infection can improve metabolic syndrome by changing the gut microbiota. Using Vonoprazan-Amoxicillin based regimens, it includes H. pylori-positive patients aged 18 to 65 with newly diagnosed metabolic syndrome, along with healthy control participants. It is being carried out in Phase 4 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Recruiting

Sponsor

Nanjing First Hospital, Nanjing Medical University

Intervention

Vonoprazan-Amoxicillin Dual Therapy, Vonoprazan-Amoxicillin with Bifidobacterium tetravaccae, Vonoprazan-Amoxicillin with Berberine

Start date

4/17/2025

Estimated completion

6/30/2026

Countries

China

Related genes

Locations

• Nanjing, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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).