Trial intelligence / Profile preview

Gut Microbiota and Metabolic Syndrome Following H. pylori Eradication

NCT07306988Phase 4

Key facts

Status: Recruiting
Start: Apr 2025
Primary completion: Jun 2026
Countries: 1
Sponsor: Nanjing First Hospital
Modality: Small Molecules, Live Biotherapeutic Products

Drugs: Bifidobacterium tetravaccineberberine
Conditions: Helicobacter pylori infectionmetabolic syndrome

Overview

Phase 4, randomised, open-label trial of Bifidobacterium tetravaccine and berberine in Helicobacter pylori infection and metabolic syndrome (4 arms), sponsored by Nanjing First Hospital. Primary endpoints: Helicobacter pylori Eradication Rate at 1 month, Change in Serum Triglycerides at 1 month and 4 more. Started Apr 2025; status: recruiting.

Design

4 arms

Study design: RandomizedOpen-label

VA group
Vonoprazan + amoxicillin for 14 days
Probiotics Group
Vonoprazan + amoxicillin + Bifidobacterium tetravaccae for 14 days
BBR Group
Vonoprazan + amoxicillin + berberine for 14 days
Healthy Controls
No treatment, observational

Who it enrols

Adults aged 18-65 with newly diagnosed metabolic syndrome and H. pylori-naïve infection, or healthy controls. Excludes patients with prior H. pylori treatment, recent use of antibiotics/PPIs, active peptic ulcers, severe comorbidities, or use of metabolic regulation medications.

Endpoints

Primary

Helicobacter pylori Eradication Rate1 month
Change in Serum Triglycerides1 month
Change in HDL Cholesterol1 month
Change in Blood Pressure1 month
Change in Waist Circumference1 month

Secondary

Change in gut microbiota alpha-diversity1 month
Change in gut microbiota beta-diversity1 month
Identification of differentially abundant bacterial taxa1 month
Serum Levels of Inflammatory Cytokines1 month
Endotoxins1 month
Gut microbiota-derived metabolites1 month

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