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ARS Home » Northeast Area » Beltsville, Maryland (BHNRC) » Beltsville Human Nutrition Research Center » Diet, Genomics and Immunology Laboratory » Research » Publications at this Location » Publication #309348
Title: Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: a phase I safety study

Author
item MERENSTEIN, DANIEL - Georgetown University Medical Center
item TAN, TINA - Georgetown University Medical Center
item Molokin, Aleksey
item SMITH, KEISHA - Georgetown University Medical Center
item ROBERTS, ROBERT - Pennsylvania State University
item SHARA, NAWAR - Medstar Research Institute
item METE, MIHRIYE - Medstar Research Institute
item SANDERS, MARY - Dairy And Food Culture Technologies
item Solano-Aguilar, Gloria

Submitted to: Gut Microbes
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 12/23/2014
Publication Date: 1/8/2015
Citation: Merenstein, D.J., Tan, T.P., Molokin, A., Smith, K.H., Roberts, R.F., Shara, N.M., Mete, M., Sanders, M.E., Solano Aguilar, G. 2015. Safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics: A phase I safety study. Gut Microbes. 6(1):66-77. DOI: 10.1080/19490976.2015.

Interpretive Summary: ARS is interested in determining the impact of health-promoting components in foods and to determine how consumption of specific food components like probiotic bacteria can enhance the health of a population. It is hypothesized that probiotic microbes such as Bifidobacterium animalis subspecies lactis (BB-12) have a beneficial immunomodulatory effect on host immune response. The purpose of this study was to determine the safety of Bb12 probiotic supplemented in a yogurt drink when consumed by a healthy group of adults who were prescribed a 10 day course of antibiotic for a respiratory infection. Secondary objectives were to assess the ability of BB-12 to induce changes on the host immune response through analysis of gene expression in the blood. A phase I, double-blinded, randomized, placebo-controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume four ounces of either BB-12 -supplemented yogurt or control yogurt daily for 10 days. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. Changes in expression levels of genes associated with immune response were found in the BB-12-supplemented group when compared to the control group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states.

Technical Abstract: Probiotics are live microorganisms that, when administered in sufficient doses, provide health benefits on the host. The United States Food and Drug Administration (FDA) requires phase I safety studies for probiotics when the intended use of the product is as a drug. The purpose of the study was to determine the safety of Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12)-supplemented yogurt when consumed by a generally healthy group of adults who were prescribed a 10-day course of antibiotics for a respiratory infection. Secondary aims were to assess the ability of BB-12 to affect the expression of whole blood immune markers associated with cell activation and inflammatory response. A phase I, double-blinded, randomized, placebo-controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume four ounces of either BB-12 -supplemented yogurt or control yogurt daily for 10 days. The primary outcome was to assess safety and tolerability, assessed by the number of reported adverse events. A total of 165 non-serious adverse events were reported, with no differences between the control and BB-12 groups. Changes in expression levels of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented group when compared to the control group. BB-12-supplemented yogurt is safe and well tolerated when consumed by healthy adults concurrently taking antibiotics. This study will form the basis for future randomized clinical trials investigating the potential immunomodulatory effects of BB-12-supplemented yogurt in a variety of disease states.