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

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

This study will see if adding a probiotic or berberine to standard H. pylori treatment helps adults with H. pylori infection and newly diagnosed metabolic syndrome improve blood sugar, cholesterol, weight, and other metabolic measures.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Nanjing First Hospital, Nanjing Medical University (Academic / other)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT07306988 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 who are H. pylori–positive by urea breath test, have newly diagnosed metabolic syndrome, have not had prior H. pylori eradication, and are willing to sign informed consent.

Not a fit: People who have had prior H. pylori eradication, have an active peptic ulcer, are allergic to the study drugs, or are already taking medications for metabolic control are unlikely to benefit from or be eligible for this protocol.

Why it matters

Potential benefit: If successful, the approach could improve metabolic measures in people with metabolic syndrome by restoring healthier gut microbiota alongside standard H. pylori eradication.

How similar studies have performed: Previous work has suggested H. pylori eradication and adjuncts like probiotics or berberine can alter gut microbiota and improve metabolic markers, but combining vonoprazan–amoxicillin with these specific adjuncts and defining the microbiota mechanism remains incompletely tested.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

• Nanjing First Hospital, Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Wanli Liu

Conditions HELICOBACTER PYLORI INFECTIONS; Metabolic Syndrome