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

• Status: Enrolling by invitation
• Trial end date: 2024-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cheng-Kung University Hospital
• Treatments: Bismuth; Bismuth tripotassium dicitrate; Esomeprazole; Metronidazole; Tetracycline

Criteria

Inclusion Criteria:

• Patients who are > 18 years

• Receive gastroscopy because of dyspepsia, acid regurgitation, melena, hematemesis, or others

Exclusion Criteria:

• Bleeding diathesis,

• Major organic diseases

• Malignancy

• Diseases treated with chemotherapy within one month

• Diseases treated with steroids within one month

• Diseases treated with antibiotics within one month,

• Users of aspirin within four weeks before enrollment

• Users of nonsteroidal anti-inflammatory drugs within four weeks before enrollment

• Users of cyclooxygenase-2 selective inhibitors within four weeks before enrollment

• History of H. pylori eradication

• Ingest probiotics or probiotics-containing yogurt with a frequency of >= twice per week one month prior to enrollment