Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID07306988

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

Led by Nanjing First Hospital, Nanjing Medical University · Updated on 2026-04-13

120

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how treating Helicobacter pylori infection may improve metabolic syndrome, which includes high blood sugar, cholesterol problems, and obesity. It explores whether adding probiotics or berberine to standard Helicobacter pylori treatment can better restore gut bacteria balance and enhance metabolic health. The study is a randomized controlled trial conducted by Nanjing First Hospital to clarify the gut microbiota's role in these effects. Participants are divided into three groups: one receives vonoprazan and amoxicillin dual therapy for 14 days, the second group receives the same treatment plus probiotics, and the third group receives the dual therapy plus berberine. The study includes healthy volunteers without infection or metabolic syndrome for comparison. Treatments are oral and monitored over a 14-day period, followed by assessments at one month. Before treatment, participants undergo breath tests, blood tests for glucose and cholesterol, stool analysis for gut bacteria, and body measurements. After one month, these tests are repeated to evaluate Helicobacter pylori eradication and changes in metabolic parameters. Researchers measure changes in blood sugar, cholesterol, blood pressure, waist size, and gut microbiota composition. Safety and adherence are monitored, with participants followed for the trial duration from screening to one-month follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 65 years
  • Confirmed Helicobacter pylori-positive status by urea breath test with no prior eradication therapy
  • Newly diagnosed metabolic syndrome according to Chinese Diabetes Society criteria
  • Voluntarily agree to join the trial and provide informed consent
  • For healthy controls: adults aged 18 to 65 years with Helicobacter pylori-negative status and normal metabolic health
  • Healthy controls must also voluntarily join and provide informed consent
Not Eligible

You will not qualify if you...

  • Allergy or hypersensitivity to study drugs such as penicillin, amoxicillin, or vonoprazan
  • Active peptic ulcer disease confirmed by endoscopy
  • Prior history of Helicobacter pylori eradication therapy
  • Use of medications for metabolic regulation like hypoglycemic or lipid-lowering drugs
  • Recent use of antibiotics, bismuth, H2-receptor antagonists, or proton pump inhibitors before enrollment
  • Current use of corticosteroids, NSAIDs, or anticoagulants
  • History of esophageal or gastric surgery
  • Pregnant or breastfeeding women
  • Severe medical conditions including liver, cardiovascular, pulmonary, or kidney diseases, or inflammatory bowel disease
  • Chronic alcohol abuse above specified limits
  • Presence of malignancies such as gastric mucosa-associated lymphoid tissue lymphoma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 14 days

Participants receive one of three oral drug regimens for 14 days aimed at eradicating Helicobacter pylori to improve metabolic syndrome parameters.

1 baseline visit and 1 visit at end of treatment

Follow-up

Duration - 1 month

Participants are monitored for changes in metabolic syndrome markers and gut microbiota after treatment.

1 follow-up visit at 1 month post-treatment

Trial Site Locations

Total: 1 location

1

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, China, 210006

Actively Recruiting

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Research Team

W

Wanli Liu

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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