Bovine lactoferrin added to triple therapy increased Helicobacter pylori eradication rate.

M e t h o d s Design: Randomized controlled trial. Allocation: Unclear allocation concealment.* Blinding: Blinded (data analyst).* Follow-up period: 9 to 11 weeks. Setting: 14 centers in Italy. Patients: 402 H. pylori–positive patients (mean age 52 y, 52% men) with dyspeptic symptoms, gastritis, and peptic ulcer disease. Exclusion criteria were previous H. pylori eradication therapy, history of definitive acidlowering surgery, reflux esophagitis > Los Angeles classification grade A, previous esophageal surgery, proton-pump inhibitors within the previous 2 weeks or any antibiotics within the previous 4 weeks, allergy to clarithromycin or benzimidazole, chronic renal and hepatic diseases, any neoplasm, or pregnancy or lactation. Intervention: Esomeprazole, 20 mg; clarithromycin, 500 mg; and tinidazole, 500 mg twice daily for 7 d (triple therapy) (n = 136); bovine lactoferrin, 200 mg twice daily for 7 days, followed by triple therapy (n = 132); or bovine lactoferrin, 200 mg twice daily, plus triple therapy (n = 134). Outcomes: H. pylori eradication (negative result on the C13 urea breath test or H. pylori stool antigen test) and side effects. Patient follow-up: 97% (intention-to-treat analysis).