Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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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