Helicobacter Pylori Infection Clinical Trial
Official title:
Adding Bismuth to Rabeprazole-based First-line Triple Therapy Does Not Improve the Eradication of Helicobacter Pylori
This randomized controlled study aimed to evaluate whether adding bismuth to the standard first-line triple therapy could improve the eradication rate of Helicobacter pylori (H. pylori). A total of 162 patients with H. pylori infection were randomly assigned to either the 7-day triple therapy group (n = 81) or the bismuth plus triple therapy group (n = 81). The triple therapy (RAK) contained the twice-daily dosage of rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg. In the RBAK group, bismuth subcitrate 360 mg twice daily was added to the RAK regimen.
Once confirmed with H. pylori infection and having signed the informed consent, participants
were randomly assigned to either the standard triple-therapy group (RAK: rabeprazole 20 mg,
amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days) or the bismuth plus
standard triple-therapy group (RBAK: rabeprazole 20 mg, bismuth subcitrate 360 mg,
amoxicillin 1 g and clarithromycin 500 mg, all twice daily for 7 days). A computer-generated
random number was chosen for randomization. The patients and physicians were not blinded to
the therapy assigned.
After completion of H. pylori eradication therapy, participants were asked to come back for
collection of the information on any adverse event of drug compliance. In order to avoid
false negative results, they were also asked to have a 4-week proton pump inhibitor,
antibiotic and bismuth washout period before further examination of H. pylori status. The
second endoscopy with rapid urea test, histology and culture or 13 C-urea breath test (UBT)
for those who refused endoscopic exams was carried out at the end of the washout period.
Those who did not return to confirm their H. pylori status were deemed as treatment failure
in intention-to-treat (ITT) analysis.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05061732 -
Helicobacter Pylori Eradication and Follow-up
|
Phase 4 | |
| Completed |
NCT03779074 -
Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies
|
Phase 3 | |
| Completed |
NCT06076681 -
A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05329636 -
Auto Fecal Microbial Transplant Post Helicobacter Pylori Antibiotic Therapy
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05065138 -
Comparison of Helicobacter Pylori Eradication Effect Before and After Training of Gastroenterologists
|
N/A | |
| Completed |
NCT05049902 -
Bismuth-containing Quadruple Therapy for Helicobacter Pylori Eradication
|
Phase 4 | |
| Not yet recruiting |
NCT06200779 -
Tailored vs. Empirical Helicobacter Pylori Infection Treatment
|
Phase 4 | |
| Not yet recruiting |
NCT06037122 -
Efficacy of Low-dose Vonoprazan for Helicobacter Pylori Eradication
|
||
| Completed |
NCT04617613 -
Comparing Different Regimens for Eradication of Helicobacter Pylori in Kuwait
|
Phase 4 | |
| Completed |
NCT02557932 -
Comparison of 7-day PPI-based Standard Triple Therapy and 10-day Bismuth Quadruple Therapy for H. Pylori Eradication
|
Phase 3 | |
| Withdrawn |
NCT02552641 -
Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole
|
Phase 4 | |
| Completed |
NCT02873247 -
Standardize Communication With General Practitioner & Patient for Improved Eradication of Helicobacter Pylori
|
||
| Recruiting |
NCT02249546 -
Efficacy of Acetylcysteine-containing Triple Therapy in the First Line of Helicobacter Pylori Infection
|
Phase 4 | |
| Completed |
NCT01933659 -
Anti-H. Pylori Effect of Deep See Water
|
Phase 3 | |
| Unknown status |
NCT01464060 -
14-day Quadruple Hybrid vs. Concomitant Therapies for Helicobacter Pylori Eradication
|
Phase 4 | |
| Completed |
NCT00841490 -
Oral H. Pylori Prevalence in Intellectually & Developmentally Disabled Adults
|
N/A | |
| Recruiting |
NCT05549115 -
Susceptibility-Guided Sequential Therapy for Helicobacter Pylori Infection
|
N/A | |
| Recruiting |
NCT05728424 -
One vs Two Weeks Treatment for H.Pylori Eradication A RANDOMIZED NON-INFERIORITY PLACEBO CONTROLLED TRIAL
|
Phase 3 | |
| Recruiting |
NCT05997433 -
Efficacy of 7-day Versus 14-day Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori（SHARE2302)
|
N/A | |
| Completed |
NCT04708405 -
The Relationship Between Helicobacter Pylori Infection and Inflammatory Bowel Diseases: A Real-life Observation
|