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Probiotics and Prebiotics in Preventing Episodes of Acute Otitis Media in High-risk Children: A Randomized, Double-blind, Placebo-controlled Study

Cohen, Robert MD*†; Martin, Elvira MD*; de La Rocque, France MD*; Thollot, Franck MD; Pecquet, Sophie MD§; Werner, Andreas MD; Boucherat, Michel MD*†; Varon, Emmanuelle MD; Bingen, Edouard PhD; Levy, Corinne MD*†

The Pediatric Infectious Disease Journal: August 2013 - Volume 32 - Issue 8 - p 810–814
doi: 10.1097/INF.0b013e31828df4f3
Original Studies

Background: Several studies have suggested that probiotics (proB) and/or prebiotics (preB) could reduce the burden of infection in infants and toddlers. We aimed to determine whether follow-up formula supplemented with proB and preB could reduce the risk of acute otitis media (AOM).

Methods: In this double-blind, placebo-controlled trial from November 2007 to April 2009, 37 pediatricians in France enrolled children 7 to 13 months of age with high risk of AOM who were randomly assigned to receive follow-up formula supplemented with proB (Streptococcus thermophilus NCC 2496, Streptococcus salivarius DSM 13084, Lactobacillus rhamnosus LPR CGMCC 1.3724) and preB (Raftilose/Raftiline) or follow-up formula alone (placebo). During 12 months, the 2 groups were compared for number of AOM episodes diagnosed (primary outcome) and secondary outcomes by the Poisson model (incidence rate ratio [IRR]) or logistic regression (odds ratio; and 95% confidence interval [95% CI]) after adjustment on covariates of interest.

Results: We enrolled 224 children (112 in each group). All children were vaccinated (4 doses) with the 7-valent pneumococcal conjugate vaccine; demographic characteristics were similar in the 2 groups. In total, 486 AOM episodes were reported, 249 and 237 in the treatment and control groups, respectively. The treatment and control groups did not differ in incidence of AOM (IRR 1.0, 95% CI: 0.8–1.2), lower respiratory tract infections (IRR 0.9, 0.7–1.2) or number of antibiotic treatment courses (IRR = 1.0, 95% CI: 0.8–1.2). Treatment was not associated with recurrent AOM (odds ratio 1.0, 95% CI: 0.5–1.7). With regard to gastrointestinal disorders, both formulas were well tolerated.

Conclusion: The proB and preB included in follow-up formula given to children at 7 to 13 months of age did not reduce the risk of AOM, recurrent AOM, antibiotic use or lower respiratory tract infections at 1 year.

From the *Association Clinique et Thérapeutique Infantile du Val de Marne, Paris; Centre de Recherche Clinique, Centre Hospitalier Intercommunal de Créteil, Créteil; Association Française de Pédiatrie Ambulatoire, Service de Microbiologie, Hôpital Robert-Debré (AP-HP), Université Denis-Diderot, Paris, France; §Nestlé Research, Vevey, Switzerland; ¶Hôpital Européen Georges Pompidou (AP-HP), Centre National de Référence des Pneumocoques, Université Paris; and Service de Microbiologie, Hôpital Robert-Debré (AP-HP), Université Denis-Diderot, Paris, France.

Accepted for publication February 18, 2013.

This work is dedicated to the memory of Nathalie Kohn Atlan and Jacques Elbhar.

This work was presented in part at the Interscience Conference on Antimicrobial Agents and Chemotherapy in September 2011 (Poster G3-181).

Financial support was provided by Nestlé, Vevey, Switzerland.

S.P. is employed by Nestlé. The authors have no other funding or conflicts of interest to disclose.

Address for correspondence: Robert Cohen, MD, Association Clinique et Thérapeutique Infantile du Val de Marne, 27 rue Inkermann, F94100 Saint Maur des Fossés, France. E-mail:

© 2013 by Lippincott Williams & Wilkins, Inc.