A Prospective Randomized Interventional Study to Establish the Role of Bovine Lactoferrin in Helicobacter Pylori Infection

Abstract

Helicobacter pylori (H. pylori) are gram-negative spiral bacterium that surrounds itself in the epithelial surface of the stomach. It is found to be the most common bacterial infection affecting the population worldwide approximately 50%. The elimination of H. pylori is not only an important component in the healing of peptic ulcers, but also to decreases their recurrence and reduces the rate of gastric carcinoma. Eradication of H. pylori is currently recommended in numerous guidelines for the treatment of all these associated diseases. In the last two decades, attention has focused on the potential role of bovine lactoferrin (bLf) in the therapy of various gut disorders. bLf, a multifunctional iron-binding glycoprotein that is found in the milk, mucosal secretions (e.g., saliva, tears, bile), pancreatic and seminal fluids, and specific granules of the polymorphonuclear leukocytes in humans. Proton-pumpbased triple therapy (PpTT) is the most commonly accepted H. pylori treatment, which consists of a twice-daily proton pump inhibitor (PPI) such as esomeprazole or pantoprazole or omeprazole; clarithromycin or amoxicillin with tinidazole for 7-14 days. The aim of our study was to evaluate the efficacy of Bovine lactoferrin, administered orally along with triple therapy on H. pylori colonization in humans by a prospective randomized controlled study. 75 Patients with H. pylori positive were recruited and treated as per the protocol for 2 weeks. The subjects were randomized into 2 groups based on inclusion and exclusion criteria, interventional group received bovine lactoferrin at a dose of 100mg twice daily along with triple therapy for 14 days and the control group received, triple therapy for the same period of 14 days. The reduction in symptoms were analyzed by using a set of questionnaire and scored by using Global Overall Symptom Scale (GOS) both prior and post treatment. The eradication of H. pylori was confirmed by (13c) Urea breath test (UBT) that has shown the eradication rate of 76.2% in interventional group and 61.1% in control group. This study results had indicated that the group received bovine lactoferrin had shown significant improvement in the H. pylori eradication. This result can be used to conclude that the role of bovine lactoferrin in the reduction of symptoms and eradication of H. pylori infection by focusing on the relatively high cure rate, good compliance to the treatment and higher quality of life.