Bovine lactoferrin for Helicobacter pylori eradication: An open, randomized, multicentre study

F. Di Mario, G. Aragona, N. Dal Bó, L. Cavallaro, V. Marcon, P. Olivieri, E. Benedetti, N. Orzès, R. Marin, G. Tafner, F. Chilovi, R. De Bastiani, F. Fedrizzi, M. Franceschi, M. H. Salvat, F. Monica, L. Piazzi, F. Valiante, U. Vecchiati, G. M. CavestroG. Comparato, V. Iori, M. Maino, G. Leandro, A. Pilotto, M. Rugge, A. Franzè

Research output: Contribution to journalArticle

Abstract

Background: Cure rates for eradication of Helicobacter pylori appear to be decreasing, thus more effective therapies must be identified. Aim: To evaluate the efficacy of bovine lactoferrin in the treatment of H. pylori infection. Methods: In a multicentred prospective study, 402 (mean age 52.4, range 19-84 years) H. pylori-positive patients were assigned to one of three regimens: group A - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for 7 days; group B - lactoferrin 200 mg b.d. for 7 days followed by the same schedule of group A; group C - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. plus lactoferrin 200 mg b.d. for 7 days. Results: Of the 402 patients, 389 completed the study. Six patients were discontinued due to side effects, one patient in group B died and six patients were lost to follow up. The eradication rate (intention-to-treat analysis) was 77% in group A (105/136), 73% in group B (97/132) and 90% in group C (120/134) (χ2-test P <0.01). The incidence of side effects was 9.5% in group A, 9% in group B and 8.2% in group C (χ2-test P = 0.1). Conclusion: This study demonstrates that bovine lactoferrin is an effective adjuvant to 7-day triple therapy for eradication of H. pylori infection.

Original languageEnglish
Pages (from-to)1235-1240
Number of pages6
JournalAlimentary Pharmacology and Therapeutics
Volume23
Issue number8
DOIs
Publication statusPublished - Apr 2006

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Lactoferrin
Helicobacter pylori
Multicenter Studies
Esomeprazole
Tinidazole
Clarithromycin
Helicobacter Infections
Intention to Treat Analysis
Lost to Follow-Up
Appointments and Schedules
Therapeutics
Prospective Studies
Incidence

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

Di Mario, F., Aragona, G., Dal Bó, N., Cavallaro, L., Marcon, V., Olivieri, P., ... Franzè, A. (2006). Bovine lactoferrin for Helicobacter pylori eradication: An open, randomized, multicentre study. Alimentary Pharmacology and Therapeutics, 23(8), 1235-1240. https://doi.org/10.1111/j.1365-2036.2006.02851.x

Bovine lactoferrin for Helicobacter pylori eradication : An open, randomized, multicentre study. / Di Mario, F.; Aragona, G.; Dal Bó, N.; Cavallaro, L.; Marcon, V.; Olivieri, P.; Benedetti, E.; Orzès, N.; Marin, R.; Tafner, G.; Chilovi, F.; De Bastiani, R.; Fedrizzi, F.; Franceschi, M.; Salvat, M. H.; Monica, F.; Piazzi, L.; Valiante, F.; Vecchiati, U.; Cavestro, G. M.; Comparato, G.; Iori, V.; Maino, M.; Leandro, G.; Pilotto, A.; Rugge, M.; Franzè, A.

In: Alimentary Pharmacology and Therapeutics, Vol. 23, No. 8, 04.2006, p. 1235-1240.

Research output: Contribution to journalArticle

Di Mario, F, Aragona, G, Dal Bó, N, Cavallaro, L, Marcon, V, Olivieri, P, Benedetti, E, Orzès, N, Marin, R, Tafner, G, Chilovi, F, De Bastiani, R, Fedrizzi, F, Franceschi, M, Salvat, MH, Monica, F, Piazzi, L, Valiante, F, Vecchiati, U, Cavestro, GM, Comparato, G, Iori, V, Maino, M, Leandro, G, Pilotto, A, Rugge, M & Franzè, A 2006, 'Bovine lactoferrin for Helicobacter pylori eradication: An open, randomized, multicentre study', Alimentary Pharmacology and Therapeutics, vol. 23, no. 8, pp. 1235-1240. https://doi.org/10.1111/j.1365-2036.2006.02851.x
Di Mario, F. ; Aragona, G. ; Dal Bó, N. ; Cavallaro, L. ; Marcon, V. ; Olivieri, P. ; Benedetti, E. ; Orzès, N. ; Marin, R. ; Tafner, G. ; Chilovi, F. ; De Bastiani, R. ; Fedrizzi, F. ; Franceschi, M. ; Salvat, M. H. ; Monica, F. ; Piazzi, L. ; Valiante, F. ; Vecchiati, U. ; Cavestro, G. M. ; Comparato, G. ; Iori, V. ; Maino, M. ; Leandro, G. ; Pilotto, A. ; Rugge, M. ; Franzè, A. / Bovine lactoferrin for Helicobacter pylori eradication : An open, randomized, multicentre study. In: Alimentary Pharmacology and Therapeutics. 2006 ; Vol. 23, No. 8. pp. 1235-1240.
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abstract = "Background: Cure rates for eradication of Helicobacter pylori appear to be decreasing, thus more effective therapies must be identified. Aim: To evaluate the efficacy of bovine lactoferrin in the treatment of H. pylori infection. Methods: In a multicentred prospective study, 402 (mean age 52.4, range 19-84 years) H. pylori-positive patients were assigned to one of three regimens: group A - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for 7 days; group B - lactoferrin 200 mg b.d. for 7 days followed by the same schedule of group A; group C - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. plus lactoferrin 200 mg b.d. for 7 days. Results: Of the 402 patients, 389 completed the study. Six patients were discontinued due to side effects, one patient in group B died and six patients were lost to follow up. The eradication rate (intention-to-treat analysis) was 77{\%} in group A (105/136), 73{\%} in group B (97/132) and 90{\%} in group C (120/134) (χ2-test P <0.01). The incidence of side effects was 9.5{\%} in group A, 9{\%} in group B and 8.2{\%} in group C (χ2-test P = 0.1). Conclusion: This study demonstrates that bovine lactoferrin is an effective adjuvant to 7-day triple therapy for eradication of H. pylori infection.",
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T1 - Bovine lactoferrin for Helicobacter pylori eradication

T2 - An open, randomized, multicentre study

AU - Di Mario, F.

AU - Aragona, G.

AU - Dal Bó, N.

AU - Cavallaro, L.

AU - Marcon, V.

AU - Olivieri, P.

AU - Benedetti, E.

AU - Orzès, N.

AU - Marin, R.

AU - Tafner, G.

AU - Chilovi, F.

AU - De Bastiani, R.

AU - Fedrizzi, F.

AU - Franceschi, M.

AU - Salvat, M. H.

AU - Monica, F.

AU - Piazzi, L.

AU - Valiante, F.

AU - Vecchiati, U.

AU - Cavestro, G. M.

AU - Comparato, G.

AU - Iori, V.

AU - Maino, M.

AU - Leandro, G.

AU - Pilotto, A.

AU - Rugge, M.

AU - Franzè, A.

PY - 2006/4

Y1 - 2006/4

N2 - Background: Cure rates for eradication of Helicobacter pylori appear to be decreasing, thus more effective therapies must be identified. Aim: To evaluate the efficacy of bovine lactoferrin in the treatment of H. pylori infection. Methods: In a multicentred prospective study, 402 (mean age 52.4, range 19-84 years) H. pylori-positive patients were assigned to one of three regimens: group A - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for 7 days; group B - lactoferrin 200 mg b.d. for 7 days followed by the same schedule of group A; group C - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. plus lactoferrin 200 mg b.d. for 7 days. Results: Of the 402 patients, 389 completed the study. Six patients were discontinued due to side effects, one patient in group B died and six patients were lost to follow up. The eradication rate (intention-to-treat analysis) was 77% in group A (105/136), 73% in group B (97/132) and 90% in group C (120/134) (χ2-test P <0.01). The incidence of side effects was 9.5% in group A, 9% in group B and 8.2% in group C (χ2-test P = 0.1). Conclusion: This study demonstrates that bovine lactoferrin is an effective adjuvant to 7-day triple therapy for eradication of H. pylori infection.

AB - Background: Cure rates for eradication of Helicobacter pylori appear to be decreasing, thus more effective therapies must be identified. Aim: To evaluate the efficacy of bovine lactoferrin in the treatment of H. pylori infection. Methods: In a multicentred prospective study, 402 (mean age 52.4, range 19-84 years) H. pylori-positive patients were assigned to one of three regimens: group A - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. for 7 days; group B - lactoferrin 200 mg b.d. for 7 days followed by the same schedule of group A; group C - esomeprazole 20 mg b.d., clarithromycin 500 mg b.d. and tinidazole 500 mg b.d. plus lactoferrin 200 mg b.d. for 7 days. Results: Of the 402 patients, 389 completed the study. Six patients were discontinued due to side effects, one patient in group B died and six patients were lost to follow up. The eradication rate (intention-to-treat analysis) was 77% in group A (105/136), 73% in group B (97/132) and 90% in group C (120/134) (χ2-test P <0.01). The incidence of side effects was 9.5% in group A, 9% in group B and 8.2% in group C (χ2-test P = 0.1). Conclusion: This study demonstrates that bovine lactoferrin is an effective adjuvant to 7-day triple therapy for eradication of H. pylori infection.

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