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The Efficacy of 10-day and 14-day Bismuth-based Quadruple Therapy in First-line H. Pylori Eradication

Study acronym: Bsm10
StatusEnrolling by Invitation
PhasePhase 4
Started
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Record History

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  1. Minor Secondary endpoints revised (5)v5
  2. Notable Primary and study completion dates: Jul 31, 2024 to Jul 31, 2028v4 Show 4 more changesShow less
    • Enrollment target: 252 to 312
    • Secondary endpoints: 4 to 5
    • Study description revised
    • Site details revised
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Minor Interventions: Bismuth Subcitrate (Drug), President AB powder (Dietary Supplement) to Bismuth Subcitrate 120 MG Oral Tablet (Drug), Esomeprazole 40mg (Drug), Lactobacillus acidophilus and Bifidobacterium lactis Bb12 (Dietary…
    • Eligibility criteria shortened, about 16 words
    • Study description expanded, about 68 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Helicobacter pylori (H. pylori) infection is the major cause of gastritis, peptic ulcer disease, and gastric cancer in adults. Bismuth-based quadruple therapy is recommended by a recent review to be the first-line treatment for H. pylori eradication, replacing clarithromycin-based triple therapy. It is because the eradication rates of triple therapy in adults have declined due to increasing clarithromycin resistance. The best regimen for H. pylori eradication should be the one which succeeds on the first attempt. However, the effectiveness and the optimal duration of bismuth-based quadruple therapy for first-line H. pylori eradication in adults are unknown. Moreover, the impacts on gut microbiota after H. pylori eradication should be concerned; for example, bismuth-based quadruple therapy decreases F. prausnitzii richness. The transient perturbation of the gut microbiota after H. pylori eradication were restored at 8 weeks and one year in subjects receiving clarithromycin-based triple therapy but not fully recovered in those receiving bismuth-based quadruple therapy. Therefore, the important issues are that the short-term and long-term gut dysbiosis and the recovery of gut F. prausnitzii depletion in H. pylori-infected adult patients after bismuth-based quadruple therapy. It is also uncertain the role of irreversible gut dysbiosis even though H. pylori is eradicated in gastric persist inflammation and progress to cancer, and whether probiotics could be helpful in recovering gut dysbiosis. The therapeutic strategy to eradicate H. pylori infection is based on antibiotics; however, this strategy not only increases drug resistant rates of the pathogen but also shapes the gut microbiota. The investigators hypothesize that bismuth-based quadruple therapy could be an optimal regimen for first-line H. pylori eradication in the era of increasing clarithromycin resistance; moreover, gut dysbiosis could be reversed after bismuth-based quadruple therapy. Furthermore, the efficacy of the10-day course is not inferior to that of the 14-day course in H. pylori eradication. The investigators also hypothesize that probiotics could restore gastric or gut dysbiosis, especially gut F. prausnitzii depletion.
Trial Details
NCT Number NCT04527055
Lead Sponsor National Cheng-Kung University Hospital
Conditions
(from sponsor)
Helicobacter Pylori Infection, Dysbiosis, Probiotics
Related terms Dysbiosis
Enrollment 312 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov