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

NCT07306988 | Recruiting Phase 4

• 1 other identifier: KY20250327-12
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.
2. 2.Who can participate? Patients: Adults aged 18-65 with both Helicobacter pylori infection (confirmed by a breath test) and newly diagnosed metabolic syndrome (based on waist size, blood sugar, cholesterol, or blood pressure).
3. 3.What will participants do?
4. 4.Possible Benefits and Risks
5. 5.How are participants protected? All treatments are FDA-approved or widely used in clinical practice.
6. 6.Study Design Type: Prospective, single-center, open-label, randomized controlled trial.
7. 7.Scientific Rationale Hp and Metabolic Syndrome: Epidemiological evidence links Hp infection to metabolic dysfunction, possibly via chronic inflammation. Eradication may partially reverse insulin resistance and dyslipidemia.
8. 8.Methodology Randomization: Block randomization (block size = 4) using SAS 9.4.
9. 9.Clinical Implications Clarify whether probiotics or BBR add value to Hp eradication in improving metabolic health.

Conditions

HELICOBACTER PYLORI INFECTIONS; Metabolic Syndrome

Outcome Measures

Primary Outcomes (6)

• Helicobacter pylori Eradication Rate

  Post-treatment follow-up at 1 month

• Change in Serum Triglycerides

  Baseline and 1 month post-treatment.

• Change in HDL Cholesterol

  Baseline and 1 month post-treatment.

• Change in Blood Pressure

  Baseline and 1 month post-treatment.

• Change in Waist Circumference

  Baseline and 1 month post-treatment.

• Change in Fasting Plasma Glucose

  Baseline and 1 month post-treatment.

Secondary Outcomes (6)

• Change in gut microbiota alpha-diversity, assessed by 16S rRNA gene sequencing

  Baseline and 1 month post-treatment.

• Change in gut microbiota beta-diversity, assessed by 16S rRNA gene sequencing

  Baseline and 1 month post-treatment.

• Identification of differentially abundant bacterial taxa (Genus level), assessed by 16S rRNA gene sequencing and statistical modeling (e.g., LEfSe or DESeq2)

  Baseline and 1 month post-treatment.

• Serum Levels of Inflammatory Cytokines (Including TNF-α, CRP, IL-6, and IL-8)

  Baseline and 1 month post-treatment.

• Endotoxins

  Baseline and 1 month post-treatment.

Study Arms (3)

VA group

EXPERIMENTAL

Drug: Vonoprazan-Amoxicillin Dual Therapy

Probiotics Group

EXPERIMENTAL

Drug: Vonoprazan-Amoxicillin with Bifidobacterium tetravaccae

BBR Group

EXPERIMENTAL

Drug: Vonoprazan-Amoxicillin with Berberine

Interventions

Vonoprazan-Amoxicillin with Bifidobacterium tetravaccae DRUG

Patients receive oral vonoprazan 20 mg twice daily, amoxicillin 1000 mg three times daily, and Bifidobacterium tetravaccae probiotic tablets (3 tablets three times daily) for 14 days.

Probiotics Group

Vonoprazan-Amoxicillin with Berberine DRUG

Patients receive oral vonoprazan 20 mg twice daily, amoxicillin 1000 mg three times daily, and berberine hydrochloride tablets (3 tablets three times daily) for 14 days.

BBR Group

Vonoprazan-Amoxicillin Dual Therapy DRUG

Patients receive oral vonoprazan 20 mg twice daily and amoxicillin 1000 mg three times daily for 14 days. This regimen is a standard dual therapy for Helicobacter pylori eradication.

VA group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For H. pylori-naïve infected patients with newly diagnosed metabolic syndrome (MS):
• Aged 18-65 years;
• Confirmed H. pylori-positive status by urea breath test (UBT), with no prior eradication therapy;
• Newly diagnosed MS according to the Chinese Diabetes Society (CDS, 2004 Chinese criteria) ;
• Voluntarily join the trial and sign informed consent.
• For H. pylori-negative healthy controls with normal metabolism:
• Aged 18-65 years;
• Confirmed H. pylori-negative status by UBT;
• Normal metabolic parameters (e.g., blood glucose, lipid profile, blood pressure) without MS;
• Voluntarily join the trial and sign informed consent.

You may not qualify if:

• Hypersensitivity to study drugs (e.g., penicillin, amoxicillin, vonoprazan);
• Active peptic ulcer confirmed by endoscopy;
• Prior history of H. pylori eradication therapy;
• Use of medications for metabolic regulation (e.g., hypoglycemic agents, lipid-lowering drugs, weight-loss drugs)
• Recent use of antibiotics or bismuth (within 4 weeks) or H2-receptor antagonists/PPIs (within 2 weeks) before enrollment;
• Current use of corticosteroids, NSAIDs, or anticoagulants;
• History of esophageal or gastric surgery;
• Pregnant or breastfeeding women;
• Severe comorbidities (e.g., hepatic, cardiovascular, pulmonary, renal diseases, inflammatory bowel disease);
• Chronic alcohol abuse (\>40 g/day for men, \>20 g/day for women);
• Malignancies (e.g., gastric mucosa-associated lymphoid tissue \[MALT\] lymphoma).

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Berberine

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Wanli Liu

CONTACT

+86 18951768998; 18951768998@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: December 29, 2025
• Study Start: April 17, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)