Helicobacter Pylori Infection Clinical Trial
Official title:
Comparison of the Efficacy of Clarithromycin-based Triple Therapy Versus Quadruple Therapies in the First Line Therapy of Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial
Whether non-bismuth quadruple therapy (concomitant therapy) is more effective than bismuth
quadruple therapy or triple therapy for 14 days remains unknown.
Therefore, we aim to compare the eradication rates and long term re-infection rates of
quadruple therapy for 10 days versus non-bismuth quadruple therapy for 10 days vs. triple
therapy for 14 days.
Methods: This will be a multi-center, open labeled, randomized control trial Patients: H.
pylori infected patients who have willingness to receive eradication therapy
Testing for H. pylori infection Before First Line Ttreatment
(1)Any two positive of rapid urease test, histology, serology and culture or a positive UBT
will be considered as H. pylori infected
After First Line Treatment: C13-Urea breath test will be used to assess the existence of H.
pylori 6-8 weeks after first line therapy.
Long term reinfection: C13- Urea breath test will be used to assess the recurrence of H.
pylori 1 year after eradication therapy
First line therapy: open labeled, randomized control trial, randomized into one of the three
groups Group (A): triple therapy for 14 days D1-D14: (lansoprazole 30mg + clarithromycin
500mg + amoxicillin 1gm) bid Group (B): non-bismuth quadruple therapy for 10 days D1-D10:
lansoprazole 30mg bid + amoxicillin 1gm bid + clarithromycin 500mg bid + metronidazole 500mg
bid Group (C): bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid +
colloidal bismuth subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid
Second line therapy: patients who fail from first line treatment will be rescue with the
following treatment Group (A) Patient who fail from triple therapy will be retreated with
bismuth quadruple therapy for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth
subcitrate 300mg tid + metronidazole 500mg tid + tetracycline 500mg tid Group (B) Patient
who fail from non-bismuth quadruple therapy will be retreated with bismuth quadruple therapy
for 10 days D1-D10: lansoprazole 30mg bid + colloidal bismuth subcitrate 300mg tid +
metronidazole 500mg tid + tetracycline 500mg tid Group (C) Patients who fail from bismuth
quadruple therapy will be retreated with non-bismuth quadruple therapy for 10 days D1-D10:
lansoprazole 30mg bid + amoxicillin 1gm bid + clarithromycin 500mg bid + metronidazole 500mg
bid
;
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 | |
Completed |
NCT02873247 -
Standardize Communication With General Practitioner & Patient for Improved Eradication of Helicobacter Pylori
|
||
Withdrawn |
NCT02552641 -
Food Effect on the Eradication Rate of H. Pylori With Triple Therapy With Esomeprazole
|
Phase 4 | |
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
|