Abstract—The management of Helicobacter pylori (H. pylori) eradication is still a matter of discussion, full effectiveness is rarely achieved, and it has many adverse effects. The use of probiotics may be associated with better eradication rates and possibly prevention of adverse events due to antibiotic therapy. The present clinical study was undertaken to evaluate the efficacy of a specially designed fermented milk product, containing Bifidobacterium lactis B420, on the eradication of H. pylori infection in a prospective, randomized, double-blind, controlled study in humans. Four test fermented milks (FM) were specially designed in which counts of viable cells in all products were 10 10 Log CFU. 100 mL -1 for Bifidobacterium lactis - Bifidobacterium species 420. 190 subjects infected with H. pylori, with previous diagnosis of functional dyspepsia according to Rome III criteria entered the study. Bifidobacterium lactis B420, administered twice a day for 90 days was not able to eradicate H. pylori in Brazilian patients with functional dyspepsia. Trial registration: Current Controlled Trials ISRCTN22923997 Keywords—Antibacterial Therapy, Bifidobacteria Fermented I. INTRODUCTION UNCTIONAL dyspepsia is a clinical syndrome that biochemical examinations and endoscopy reveal no organic lesions or findings. The primary symptoms are epigastric pain, early satiety and post-prandial fullness [1]. The management of functional dyspepsia is a challenge for gastroenterologists in clinical practice. Helicobacter pylori (H. pylori) eradication is one of the main strategies to treat this disease [2]. H. pylori is a gram negative, microaerophilic, spiral bacterium that colonizes human stomach [3]. The ability to produce urease is a central biochemical characteristic and could be used to determine positive subjects [3]. H. pylori infection affects more than 50% of the world’s population. Its prevalence in the development countries is around 80%, initially infected during childhood [4], [5]. R.C.B., C.H., J.N.E. and T.N.R. are with University of São Paulo School of Medicine - Department of Gastroenterology - São Paulo, Brazil. N.P., C.S.B., M.N.O. are with University of São Paulo - Biochemical Pharmaceutical Technology Department - São Paulo, Brazil (e-mail: cris.bogsan@usp.br). P.B. is with Brazil Food BRF – São Paulo, Brazil. H. pylori eradication is achieved usually with antibiotics associated with a proton pump inhibitor (PPI). In Brazil, the recommended the first line treatment is composed by a PPI plus clarithromycin and amoxicillin [6], [7]. Eradication rates with this scheme in countries such as ours, with low clarithromycin resistance, are around 90%. However, combination of two antibiotics is frequently associated with adverse effects and contributes to the increase in antibiotic resistance [7]. In this context, probiotics have emerged as potential candidates as an alternative therapy [8]-[10]. Animal, human and in vitro studies that evaluated H. pylori and probiotics could demonstrate an in vitro inhibitory effect of probiotics on H. pylori. Those animal studies demonstrated that some probiotic strains are effective in reducing H. pylori – associated gastric inflammation [10]. Moreover, an improvement of H. pylori gastritis and decrease H. pylori density after administration of probiotics was also observed in human studies [9]-[11]. A meta-analysis by [11] of randomized controlled trials on the efficacy of probiotics in H. pylori eradication therapy in children, concluded that the probiotics were beneficial in decreasing side effects secondary to triple therapy for H. pylori eradication, particularly diarrhoea. However, the efficacy of probiotics for H. pylori eradication in adults remains controversial [11]. Most studies used lactobacilli species like L. johnsonii La1, either in a fermented milk preparation containing live bacteria [10], [12]-[15] or as a free-cell culture supernatant [12], [16], [17]. On the contrary, few studies used bifidobacteria [18], [19]. Bifidobacteria have been extensively used in various food formulations due to its strong adhesion to human intestinal mucosa and its high capacity for colonization [20]. Some authors have shown that some species are capable of stabilizing the intestinal microbiota during and after antibiotic therapy [21], modulate the immune system, protect against chemically induced inflammatory bowel disease and reduce symptoms of colitis [22]. It may have beneficial effects in increasing eradication rates of H. pylori in the adults and also reducing the incidence of side effects [19]. The present clinical study was undertaken to evaluate the efficacy of a specially designed fermented milk product containing Bifidobacterium lactis B420 on the eradication of Bifidobacterium lactis Fermented Milk Was Not Effective for Helicobacter pylori Eradication: A Prospective, Randomized, Double-Blind, Controlled Study R. C. Barbuti, M. N. Oliveira, N. P. Perina, C. Haro, P. Bosch, C. S. Bogsan, J. N. Eisig, T. Navarro-Rodriguez F milk, Helicobacter pylori, probiotics. World Academy of Science, Engineering and Technology International Journal of Nutrition and Food Engineering Vol:9, No:3, 2015 270 International Scholarly and Scientific Research & Innovation 9(3) 2015 scholar.waset.org/1307-6892/10000727 International Science Index, Nutrition and Food Engineering Vol:9, No:3, 2015 waset.org/Publication/10000727