Helicobacter Infections Clinical Trial
Official title:
A Randomized Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
The proposed study will test the hypothesis that H. pylori can be eradicated successfully
(>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen:
rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in
patients with peptic ulcers and H. pylori related gastritis.
Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be
enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests,
documenting H.pylori infection, will be randomized into one of two groups: Full dose or half
dose the concomitant regimen, with 100 patients in each group. Compliance and side effects
will be assessed, and a urea breath test will be done for all patients after 4 weeks of
therapy completion to evaluate eradication rates. Success of therapy will be evaluated
according to intent-to treat and per-protocol analyses.
Infection with H. pylori has been linked with chronic active gastritis, peptic ulcer
disease, adenocarcinoma and Non-Hodgkin's lymphoma of the stomach. Eradication of this
organism has been recommended for patients with peptic ulcer disease, low-grade gastric
mucosa-associated lymphoid tissue lymphoma, atrophic gastritis, unexplained iron deficiency
anemia, chronic idiopathic thrombocytopenic purpura, as well as first-degree relatives of
gastric cancer patients.
Guidelines still recommend using triple therapy regimen of PPI, clarithromycin and
amoxicillin/metronidazole twice daily for 7 to 14 days. Over the years, it has become clear
that the first-line triple therapy is loosing efficacy worldwide with PP and ITT eradication
rates inferior to 80%. Antimicrobial resistance plays an important role in some of these
failures.
Major H. pylori study groups in the world have agreed that alternative treatment regimens
are urgently needed. So far, 2 alternative treatment regimens have shown superiority over
the first-line treatment protocols: the sequential therapy consisting of a combination of
amoxicillin and a PPI twice a day for 5 days followed by another 5 days of the PPI plus
clarithromycin and tinidazole/metronidazole, and the concomitant non-bismuth quadruple
regimen consisting of PPI, clarithromycin, metronidazole, and amoxicillin twice daily.
The proposed study will test the hypothesis that H. pylori can be eradicated successfully
(>85%) using half-or full-dose "concomitant" non-bismuth quadruple therapy regimen:
rabeprazole, amoxicillin, clarithromycin and metronidazole twice daily for 7 days in
patients with peptic ulcers and H. pylori related gastritis.
Two hundred patients from the outpatient department and the endoscopy unit at AUBMC will be
enrolled in this open-label trial. Patients with positive CLO tests or urea breath tests,
documenting H.pylori infection, will be randomized into one of two groups: Full dose or half
dose the concomitant regimen, with 100 patients in each group. Compliance and side effects
will be assessed, and a urea breath test will be done for all patients after 4 weeks of
therapy completion to evaluate eradication rates. Success of therapy will be evaluated
according to intent-to treat and per-protocol analyses.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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