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

Summary 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.