Clinical trial evaluating amoxicillin and clarithromycin hydrogels (Chitosan-polyacrylic acid polyionic complex) for H. pylori eradication.
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.
Gisbert
Javier P
JP
Gastroenterology Unit, La Princesa University Hospital, Autonomous University, School of Pharmacy, Alcalá de Henares University, Alcalá de Henares, Spain. gisbert@meditex.es
Torrado
Guillermo
G
Torrado
Santiago
S
Olivares
David
D
Pajares
José María
JM
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
D000180:Acrylic Resins; D000900:Anti-Bacterial Agents; D001672:Biocompatible Materials; D020100:Hydrogels; C065246:chitosan-poly(acrylic acid); D000658:Amoxicillin; D048271:Chitosan; D017291:Clarithromycin