TY - JOUR
T1 - Safety of Bifidobacterium animalis subsp. Lactis (B. Lactis) strain BB-12-supplemented yogurt in healthy adults on antibiotics
T2 - A phase I safety study
AU - Merenstein, Daniel J.
AU - Tan, Tina P.
AU - Molokin, Aleksey
AU - Smith, Keisha Herbin
AU - Roberts, Robert F.
AU - Shara, Nawar M.
AU - Mete, Mihriye
AU - Sanders, Mary Ellen
AU - Solano-Aguilar, Gloria
N1 - Funding Information:
We thank all the individuals who participated in this study, Emily Furumoto, the Berkey Creamery at Penn State University, Pilar Hamilton, Haewon Park, R. Scott Flinn, student research assistants, and the Capital Area Primary Care Research Network. We would also like to thank Data Safety Monitoring Board Chair Marie Diener-West and members Felice Roggen, Marguerite Duane and Tamar Ringel-Kulka, and Bryan Vinyard, Director of Biometrics Consulting Service, ARS-USDA, for statistical analysis of transcriptomic data. We would also like to express our gratitude to Linda C. Duffy, National Institutes of Health program officer for the NIH Division of Extramural Research at NCCAM, and the Office of Clinical and Regulatory Affairs for their help and support.
Funding Information:
The project described was supported by Award Number U01AT003600 from the NIH National Center for Complementary and Alternative Medicine and partial support from in-house ARS-USDA project 1235-51000-051-00D. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Complementary and Alternative Medicine or the National Institutes of Health.
PY - 2015
Y1 - 2015
N2 - 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 controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. 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. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented 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.
AB - 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 controlled study was conducted in compliance with FDA guidelines for an Investigational New Drug (IND). Forty participants were randomly assigned to consume 4 ounces of either BB-12 -supplemented yogurt or non-supplemented control yogurt daily for 10 d. 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. When compared to the control group, B lactis fecal levels were modestly higher in the BB-12-supplemented group. In a small subset of patients, changes in whole blood expression of genes associated with regulation and activation of immune cells were detected in the BB-12-supplemented 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.
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U2 - 10.1080/19490976.2015.1005484
DO - 10.1080/19490976.2015.1005484
M3 - Article
C2 - 25569274
AN - SCOPUS:84924279798
VL - 6
SP - 66
EP - 77
JO - Gut Microbes
JF - Gut Microbes
SN - 1949-0976
IS - 1
ER -