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

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. 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. 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).

Healthy Volunteers: Adults aged 18-65 with no Hp infection and normal metabolic health (to compare results).

Exclusions:

Allergy to study medications (e.g., penicillin).

Previous Hp treatment, recent antibiotic/steroid use, pregnancy, or serious medical conditions (e.g., liver/kidney disease).
3. What will participants do?

Treatment Groups:

Group A: Take two medications (vonoprazan + amoxicillin) for 14 days.

Group B: Take the two medications + probiotics (Bifidobacterium tablets).

Group C: Take the two medications + berberine (a plant-based supplement).

Tests:

Before treatment: Breath test, blood tests (blood sugar, cholesterol, inflammation markers), stool sample analysis (gut bacteria), and body measurements (weight, waist size).

After treatment (1 month): Repeat tests to check Hp eradication and metabolic improvements.
4. Possible Benefits and Risks

Benefits:

Free Hp treatment and metabolic health monitoring.

Potential improvement in blood sugar, cholesterol, or weight.

Contribution to future treatments for metabolic syndrome.

Risks:

Mild side effects (e.g., nausea, diarrhea, stomach pain) from medications.

Discomfort from blood draws or stool sample collection.
5. How are participants protected? All treatments are FDA-approved or widely used in clinical practice.

Ethical review ensures participant safety.

You can withdraw at any time without affecting your regular care.

Information for Health Care Providers

1. Study Design Type: Prospective, single-center, open-label, randomized controlled trial.

Population: 140 participants (120 Hp+ patients with metabolic syndrome; 20 Hp- healthy controls).

Intervention:

Group A: Vonoprazan (20 mg bid) + amoxicillin (1 g tid) for 14 days.

Group B: Group A + Bifidobacterium tetragenous probiotic (3 tablets tid).

Group C: Group A + berberine (3 tablets tid).

Primary Outcomes:

Hp eradication rate (confirmed by urea breath test).

Changes in metabolic parameters (fasting glucose, HbA1c, lipid profile).

Gut microbiota composition (16S rRNA sequencing).

Secondary Outcomes:

Multi-omics analysis (inflammation markers, endotoxins, short-chain fatty acids, bile acids).
2. 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.

Gut Microbiota as Mediator: Hp eradication alters gut microbiota, which regulates metabolic homeostasis through metabolites (e.g., SCFAs), bile acid metabolism, and inflammatory pathways. Probiotics/BBR may enhance these effects.
3. Methodology Randomization: Block randomization (block size = 4) using SAS 9.4.

Assessments:

Metabolic Parameters: Fasting glucose, HbA1c, lipid profile, BMI.

Microbiome: 16S rRNA sequencing (α/β diversity, taxa abundance).

Multi-omics: ELISA (TNF-α, IL-6), GC-MS (SCFAs), UPLC-MS (bile acids).

Statistical Analysis:

Microbiome: QIIME2, LEfSe, PICRUSt2.

Multi-omics: limma, SparCC, sPLS-DA.

Clinical data: ANOVA, χ² tests (SPSS v25.0).
4. Clinical Implications Clarify whether probiotics or BBR add value to Hp eradication in improving metabolic health.

Identify gut microbiota-driven mechanisms linking Hp eradication to metabolic benefits.

Resources for Participants

Study Flowchart:

Screening: Breath test, blood/stool tests (1 week).

Treatment: 14 days of medication.

Follow-up: Repeat tests at 1 month.

Contact Information:

Dr. Wanli Liu: +86-18951670222

Nanjing First Hospital Gastroenterology Department.

FAQ Sheet:

Can I take my regular medications? Yes, unless they interfere with Hp treatment (e.g., PPIs).

What if I miss a dose? Contact the study team immediately.

Ethical Compliance Approved by the Institutional Review Board of Nanjing First Hospital.

Complies with the Declaration of Helsinki and China's ethical guidelines.

Informed consent required for participation.

Conditions

• HELICOBACTER PYLORI INFECTIONS
• Metabolic Syndrome

Interventions

DRUG

Vonoprazan-Amoxicillin Dual Therapy

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.

DRUG

Vonoprazan-Amoxicillin with Bifidobacterium tetravaccae

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.

DRUG

Vonoprazan-Amoxicillin with Berberine

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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-17

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• China

Study Locations