Clinical Trial Evaluating Amoxicillin and Clarithromycin Hydrogels (Chitosan-polyacrylic Acid Polyionic Complex) for H. pylori Eradication

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Abstract

Aim

It has been suggested that enhancement of amoxicillin or clarithromycin concentration at the gastric tissue may improve the anti-Helicobacter pylori effect of these drugs. This could be achieved by allowing the drug to remain longer in the stomach using dried hydrogels. Our aim was to evaluate the efficacy of an H. pylori eradication regimen including both amoxicillin and clarithromycin hydrogels.

Methods

Design: prospective clinical trial. Patients: with peptic ulcer or functional dyspepsia. Intervention: 7-day rabeprazole-amoxicillin-clarithromycin regimen. In addition, amoxicillin and clarithromycin hydrogels were administered twice daily during the 7 days. The polyionic complex hydrogel was prepared with Chitosan and polyacrylic acid. Outcome: H. pylori eradication was defined as a negative 13C-urea breath test 8 weeks after completing therapy.

Results

Forty patients were included. One patient did not return for follow-up. Ninety percent of the patients took all the medications correctly. Per-protocol and intention-to-treat eradication rates were 74% (95% CI=58%–86%) and 70% (55%–82%). Mild adverse effects were reported in 4 (10%) patients (diarrhea in 3, and nausea/heartburn in 1).

Conclusions

Although dried polyionic complexes could serve as suitable candidates for amoxicillin and clarithromycin site-specific delivery in the stomach, its addition does not increase the eradication efficacy of the generally prescribed proton pump inhibitor plus amoxicillin and clarithromycin regimen.

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