Helicobatcer Pylori, First-Line Eradication
Conditions
Keywords
bismuth, triple therapy, tetracycline, proton pump inhibitor
Brief summary
Most international treatment guidelines currently recommend a 14-day bismuth quadruple therapy as the first-line treatment for Helicobacter pylori infection, especially in areas with high clarithromycin resistance. While this therapy boasts good eradication rates, its administration is complex and has a high incidence of adverse reactions. However, tetracycline is one of the most effective anti-Helicobacter pylori antibiotics, with a resistance rate of less than 3%. This study prospectively evaluates the efficacy and safety of a 14-day triple therapy (high-dose tetracycline combined with bismuth and PPI) versus a 14-day bismuth quadruple therapy as first-line eradication therapy. This novel single-antibiotic therapy has the potential to become a new standard of care for Helicobacter pylori eradication.
Interventions
DRUGBismuth
14-day Bismuth-Tetracycline-Rabeprazole Triple
Bismuth quadruple therapy, combining Rabeprazole, Tetracycline, Bismuth, and Metronidazole
Sponsors
Chih-An Shih, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In this single-center, randomized, open-label trial, we will enroll 300 adults infected with Helicobacter pylori. Subjects will be randomly assigned using a computer-generated randomization sequence (1:1 ratio) to receive one of the following treatments: (1) a 14-day combination therapy of bismuth-tetracycline-rabeprazole, or (2) a 14-day combination therapy of bismuth-rabeprazole-tetracycline-metronidazole.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
adult patients (aged ≥18 years) who underwent esophagogastroduodenoscopy for the evaluation of gastrointestinal symptoms at Antai Tian-Sheng Memorial Hospital. Eligible individuals were invited to participate in an H. pylori screening program. Those who met either of the following criteria were considered for enrollment: (1) positive results from both the rapid urease test and histology, or (2) a positive culture result.
Exclusion criteria
(1) previous H. pylori eradication therapy, (2) a history of gastrectomy, (3) allergy to any of the eradication medications used in this study, (4) antibiotic use within 4 weeks before treatment, (5) the absence of post-treatment assessment for H. pylori eradication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| eradication rate | 6 weeks | Follow-up at week 2 will assess treatment adherence and adverse events. H. pylori status will be evaluated at week 6 using the C13-urea breath test. Eradication and adverse event rates will be compared between groups using the chi-square test. |
Countries
Taiwan
Contacts
CONTACTChih-An Shih, Doctor of Medicine
CONTACTChang-Yi Li, Bachelor
PRINCIPAL_INVESTIGATORChih-An Shih, Doctor of Medicine
Antai Medical Care Corporation, Antai Tian-Sheng Memorial Hospital
Outcome results
None listed