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The study to investigate the potential benefits of probiotics in yogurt, a patient-oriented, double-blind, cluster-randomised, placebo-controlled, clinical trial

European Journal of Clinical Nutrition volume 64, pages 685–691 (2010)Cite this article

Subjects

Abstract

Background:

Probiotic functional foods are widely advertised to consumers primarily based on probiotic supplements.

Objective:

Determine if consumption of yogurt containing a high dose of probiotics improves health in children ages 1–3 years attending daycare/school centers.

Subjects/Methods:

Double-blinded, randomized, placebo-controlled, allocation concealment clinical trial. Setting: Outpatient participants in the Washington, DC area. Participants: 182 healthy children between the age of 1 and 3 years attending daycare/school at least 3 days a week. Intervention: Active was a strawberry yogurt-based drink supplemented with Bifidobacterium animalis ssp. lactis (B. lactis) BB-12. The placebo was indistinguishable from the active drink, differing only in absence of the probiotic BB-12. Primary objective was to determine if consumption of a probiotic-containing yogurt-based drink decreases absences due to illnesses from daycare for children ages 1–3 years. Secondary was to determine if probiotic-containing yogurt-based drink improves overall parental satisfaction due to decreased absences from work and an overall healthier child.

Results:

There were no significant differences in the days of missed school per group, with 51.9% in the active group and 47.1% in the placebo group missing at least 1 day of school throughout the study. Additionally, there were no differences in any secondary outcomes among the groups.

Conclusions:

Consumption of a yogurt-based drink delivering 1010 CFU of Bifidobacterium animalis ssp. lactis (B. lactis) BB-12 per day did not decrease the number of days missed of school due to an illness. Additional independent research on the potential of BB-12 to reduce illness in children needs to be conducted.

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Abbreviations

BB-12:

Bifidobacterium animalis ssp. lactis (B. lactis)

AE:

adverse events

SAE:

serious adverse events

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Acknowledgements

We would like to thank Jaclyn N. McCallister, research assistant, CAPRICORN research coordinators Haewon Park and Tina Tan, for their invaluable help, without whom this study would not have occurred. Dr's Mirjana Curic and Dave McCoy from Chr. Hansen for their help in obtaining cultures and help throughout the study. We would also like to thank the Data Safety Monitoring Board, Dr Seiji Hayashi George Washington University; Dr David Meyers the Agency for Healthcare Research and Quality and Dr Susan Crystal-Mansour community representative. We are also indebted to Cathy Obits Program Manager of the Gerber Foundation and the entire Foundation for their help and financial support.

Study concept and design: Merenstein, Roberts, Petterson, Sanders.

Acquisition of data: Merenstein, Scriven, Herbin-Smith.

Analysis and interpretation of data: Merenstein, Scriven, Herbin-Smith, Roberts, Petterson, Sanders.

Initial Drafting of the manuscript: Merenstein, Scriven, Herbin-Smith.

Critical revision of the manuscript for important intellectual content: Roberts, Petterson, Sander.

Statistical analysis: Petterson, Merenstein.

Obtained funding: Merenstein.

Author information

Authors and Affiliations

  1. Department of Family Medicine, Georgetown University Medical Center, Washington, DC, USA

    D J Merenstein, K H Smith & M Scriven

  2. Department of Food Science, The Pennsylvania State University, University Park, PA, USA

    R F Roberts

  3. Dairy and Food Culture Technologies, Centennial, CO, USA

    M E Sanders

  4. Robert Graham Center, Washington, DC, USA

    S Petterson

Authors
  1. D J Merenstein
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  2. K H Smith
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  3. M Scriven
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  4. R F Roberts
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  5. M E Sanders
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  6. S Petterson
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Corresponding author

Correspondence to D J Merenstein.

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Competing interests

Dr Mary Ellen Sanders consults for numerous different probiotic manufacturers. No other authors report conflict of interest.

Additional information

Contributors: This study was funded by The Gerber Foundation. The Gerber Foundation supports research regarding the health and nutrition of infants and young children from 0 to 3 years of age. PI had full legal ability to publish any findings.

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Merenstein, D., Smith, K., Scriven, M. et al. The study to investigate the potential benefits of probiotics in yogurt, a patient-oriented, double-blind, cluster-randomised, placebo-controlled, clinical trial. Eur J Clin Nutr 64, 685–691 (2010). https://doi.org/10.1038/ejcn.2010.30

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