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

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

Eradication of Helicobacter Pylori Improves Metabolic Syndrome Through Modulation of Gut Microbiota. (NCT07306988) is a Phase 4 interventional studying HELICOBACTER PYLORI INFECTIONS and Metabolic Syndrome, sponsored by Nanjing First Hospital, Nanjing Medical University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused HELICOBACTER PYLORI INFECTIONS subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. - 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 willing to sign a consent form. Who Should NOT Join This Trial: 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). Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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).

Treatments Being Tested

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.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07306988), the sponsor (Nanjing First Hospital, Nanjing Medical University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07306988 clinical trial studying?

Who can participate in NCT07306988?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07306988?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07306988. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07306988. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.