Treating H. pylori infection to help metabolic syndrome by changing gut bacteria.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 4 interventional trial enrolls adults aged 18–65 with confirmed H. pylori infection and newly diagnosed metabolic syndrome, plus a group of H. pylori-negative healthy controls. Participants with H. pylori will receive vonoprazan–amoxicillin dual therapy alone or combined with either Bifidobacterium tetravaccae (probiotic) or berberine, and metabolic and gut microbiota measures will be tracked before and after treatment. Diagnosis is by urea breath test and the protocol excludes people with prior eradication therapy, active peptic ulcer, drug hypersensitivity, or current metabolic medications. The study runs at Nanjing First Hospital over a roughly six-month period with microbiome sampling and standard metabolic labs to explore mechanistic links.

Why it matters

Who can join: the full rules

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).

Where it's running

• Nanjing First Hospital, Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Wanli Liu
• Email: 18951768998@163.com
• Phone: +86 18951768998

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.