Bovine lactoferrin for Helicobacter pylori eradication: an open, randomized, multicentre study.
BACKGROUND
Cure rates for eradication of Helicobacter pylori appear to be decreasing, thus more effective therapies must be identified.


OBJECTIVE
To evaluate the efficacy of bovine lactoferrin in the treatment of H. pylori infection.


METHODS
In a multicentered 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) (chi(2)-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 (chi(2)-test P = 0.1).


CONCLUSIONS
This study demonstrates that bovine lactoferrin is an effective adjuvant to 7-day triple therapy for eradication of H. pylori infection.
Di Mario
F
F
Gastroenterology, University of Parma, Parma, Italy. francesco.dimario@unipr.it
Aragona
G
G
Dal Bó
N
N
Cavallaro
L
L
Marcon
V
V
Olivieri
P
P
Benedetti
E
E
Orzès
N
N
Marin
R
R
Tafner
G
G
Chilovi
F
F
De Bastiani
R
R
Fedrizzi
F
F
Franceschi
M
M
Salvat
M H
MH
Monica
F
F
Piazzi
L
L
Valiante
F
F
Vecchiati
U
U
Cavestro
G M
GM
Comparato
G
G
Iori
V
V
Maino
M
M
Leandro
G
G
Pilotto
A
A
Rugge
M
M
Franzè
A
A
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002417:Cattle; D016009:Chi-Square Distribution; D017291:Clarithromycin / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D064098:Esomeprazole / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D007781:Lactoferrin / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D014011:Tinidazole / Q000627:therapeutic use; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D014011:Tinidazole; D007781:Lactoferrin; D017291:Clarithromycin; D064098:Esomeprazole