Clinical Trials Study
Copyright ©The Author(s) 2015. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Jun 7, 2015; 21(21): 6698-6705
Published online Jun 7, 2015. doi: 10.3748/wjg.v21.i21.6698
Low efficacy of levofloxacin-doxycycline-based third-line triple therapy for Helicobacter pylori eradication in Italy
Omero Alessandro Paoluzi, Giovanna Del Vecchio Blanco, Emanuela Visconti, Manuela Coppola, Carla Fontana, Marco Favaro, Francesco Pallone
Omero Alessandro Paoluzi, Giovanna Del Vecchio Blanco, Emanuela Visconti, Manuela Coppola, Francesco Pallone, Gastroenterology Unit, Department of Internal Medicine, University Tor Vergata, 00133 Roma, Italy
Carla Fontana, Marco Favaro, Department of Experimental Medicine and Surgery, University Tor Vergata, 00133 Roma, Italy
Author contributions: Paoluzi OA and Del Vecchio Blanco G contributed equally to this work; Visconti E and Coppola M conducted clinical activities; Fontana C and Favaro M performed microbiology assessments; Pallone F contributed to write the paper.
Informed consent: All study participants or their legal guardian provided informed written consent prior to study enrollment.
Conflict-of-interest: No potential conflicts of interest relevant to this article were reported.
Data sharing: No additional data are available.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Correspondence to: Omero Alessandro Paoluzi, MD, Gastroenterology Unit, Department of Internal Medicine, University Tor Vergata, Viale Oxford 81, 00133 Roma, Italy.
Telephone: +39-6-20900969 Fax: +39-6-20903738
Received: December 18, 2014
Peer-review started: December 18, 2014
First decision: January 8, 2015
Revised: January 23, 2015
Accepted: February 13, 2015
Article in press: February 13, 2015
Published online: June 7, 2015

AIM: To evaluate a levofloxacin-doxycycline-based triple therapy with or without a susceptibility culture test in non-responders to Helicobacter pylori (H. pylori) eradication.

METHODS: A total of 142 (99 women, 43 men; mean 53.0 ± 12.7 years) non-responders to more than two H. pylori eradication therapies underwent susceptibility culture tests or were treated with a seven-day triple therapy consisting of esomeprazole, 20 mg b.i.d., levofloxacin, 500 mg b.i.d., and doxycycline, 100 mg b.i.d., randomly associated with (n = 71) or without (n = 71) Lactobacillus casei DG. H. pylori status was checked in all patients at enrollment and at least 8 wk after the end of therapy. Compliance and tolerability of regimens were also assessed.

RESULTS: H. pylori eradication was achieved in < 50% of patients [per prototol (PP) = 49%; intention to treat (ITT) = 46%]. Eradication rate was higher in patients administered probiotics than in those without (PP = 55% vs 43%; ITT = 54% vs 40%). Estimated primary resistance to levofloxacin was 18% and multiple resistance was 31%. Therapy was well tolerated, and side effects were generally mild, with only one patient experiencing severe effects.

CONCLUSION: Third-line levofloxacin-doxycycline triple therapy had a low H. pylori eradication efficacy, though the success and tolerability of this treatment may be enhanced with probiotics.

Keywords: Doxycycline, Eradication therapy, Urea breath test, Esomeprazole, Levofloxacin, Helicobacter pylori

Core tip:Helicobacter pylori eradication therapy should be based on a culture sensitivity test or include antibiotics not already used by patients who failed to respond to two or more previous attempts. Third-line levofloxacin-based triple therapy was demonstrated to be effective in such kind of patients. In the present study, a third-line levofloxacin-doxycycline triple therapy, associated or not with probiotics, was able to eradicate H. pylori infection in about 50% of patients. The low eradication rate achieved by the study regimen was probably due to levofloxacin resistance. Further studies on larger series are needed to confirm the efficacy of levofloxacin-containing regimens in Italy.