a trial of standard vs half dose rabeprazole, clarithromycin, metronidazole and amoxicillin in the treatment of helicobacter pylori infection

Conditions: Helicobacter Infections

Summary: 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.

Eligibility criteria:
inclusion criteria: * documented h.pylori infection by a clo test or a urea breath test * sign the informed consent exclusion criteria: * age under 18 or older than 80 years * allergies to any of the drugs used * recent antibiotic therapy (within 2 weeks of enrolment) * severe ulcers or bleeding * gastric perforation or obstruction * previous gastrectomy * gastric cancer * pregnancy or lactation * prior eradication therapy for h. pylori * severe concomitant disease or condition making the treatment unlikely to be effective i.e. alcoholism, drug addiction, and history of poor compliance.

Keywords: helicobacter pylori infection quadruple therapy amoxicillin metronidazole clarithromycin rabeprazole