title: Clinical trial evaluating amoxicillin and clarithromycin hydrogels (Chitosan-polyacrylic acid polyionic complex) for H. pylori eradication.
abstract: OBJECTIVE
  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
  
  
  
  METHODS
  prospective clinical trial.
  
  
  METHODS
  with peptic ulcer or functional dyspepsia.
  
  
  METHODS
  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.
  
  
  RESULTS
  H. pylori eradication was defined as a negative C-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.
authors.affiliation: Gastroenterology Unit, La Princesa University Hospital, Autonomous University, School of Pharmacy, Alcalá de Henares University, Alcalá de Henares, Spain. gisbert@meditex.es
authors.forename: Javier P
authors.initials: JP
authors.lastname: Gisbert
authors.forename: Guillermo
authors.initials: G
authors.lastname: Torrado
authors.forename: Santiago
authors.initials: S
authors.lastname: Torrado
authors.forename: David
authors.initials: D
authors.lastname: Olivares
authors.forename: José María
authors.initials: JM
authors.lastname: Pajares
mesh_terms: D000180:Acrylic Resins / Q000627:therapeutic use; D000328:Adult; D000658:Amoxicillin / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001672:Biocompatible Materials / Q000627:therapeutic use; D048271:Chitosan / Q000627:therapeutic use; D017291:Clarithromycin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D020100:Hydrogels; D008297:Male; D008875:Middle Aged
chemical_list: D000180:Acrylic Resins; D000900:Anti-Bacterial Agents; D001672:Biocompatible Materials; D020100:Hydrogels; C065246:chitosan-poly(acrylic acid); D000658:Amoxicillin; D048271:Chitosan; D017291:Clarithromycin