Safety aspects of probiotic bacterial strains Lactobacillus rhamnosus HN001 and Bifidobacterium animalis subsp. lactis HN019 in human infants aged 0–2 years |
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| Authors: | James W Dekker Kristin Wickens Peter N Black Thorsten V Stanley Edwin A Mitchell Penny Fitzharris Gerald W Tannock Gordon Purdie Julian Crane |
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| Affiliation: | 1. Fonterra Innovation, Fonterra Co-operative Group Limited, Dairy Farm Road, Palmerston North, New Zealand;2. Wellington Asthma Research Group, Wellington School of Medicine and Health Sciences, University of Otago, New Zealand;3. Department of Pharmacology & Clinical Pharmacology, University of Auckland, New Zealand;4. Department of Paediatrics, Wellington School of Medicine and Health Sciences, University of Otago, New Zealand;5. Department of Paediatrics, University of Auckland, Auckland, New Zealand;6. Immunology Department, Auckland Hospital, New Zealand;7. Microbiology Department, University of Otago, New Zealand;8. Department of Public Health, Wellington School of Medicine and Health Sciences, University of Otago, New Zealand;1. Griffith Health Institute, Griffith University, QLD 4215, Australia;2. Physiology, Australian Institute of Sport, Canberra, ACT 2617, Australia;3. Medical School, Australian National University, Canberra, ACT 2600, Australia;4. NHMRC Clinical Trials Centre, University of Sydney, NSW 1450, Australia;5. DuPont Nutrition & Health, Danisco Sweeteners Oy, Health & Nutrition, Sokeritehtaantie 20, 02460 Kantvik, Finland;6. Australian Institute of Sport, Canberra, ACT 2617, Australia;1. Department of Food Science, University of Copenhagen, Denmark;2. Bioneer-FARMA, Department of Pharmacy, University of Copenhagen, Denmark;3. Toms Confectionary Group A/S, Ballerup, Denmark;4. Department of Food Gastronomy and Food Hygiene, Warsaw University of Life Science - SGGW, Poland;1. Active Nutrition, DuPont Nutrition & Health, Sokeritehtaantie 20, Kantvik 02460, Finland;2. Changhai Hospital, No. 800, Xiangyin Road, Shanghai 200433, China;3. Sprim, 1 Daniel Burnham Court, Suite 100C, San Francisco, 94109, CA USA;4. Sprim China, 200 NingHai East Rd, Shanghai 200021, China;5. DuPont Nutrition & Health USA, 3329 Agriculture Drive, Madison 53716, WI USA;1. School of Pharmaceutical Sciences, Guangzhou University of Chinese Medicine, Guangzhou 510006, PR China;2. School of Pharmaceutical Sciences (Shenzhen), Sun Yat-sen University, Guangzhou 510006, PR China;3. Infinitus (China) Company Ltd, Guangzhou 510623, PR China;1. University of Copenhagen, Faculty of Science, Department of Food Science, Rolighedsvej 30, Frederiksberg 1958, Denmark;2. University of Copenhagen, Department of Human Nutrition, Rolighedsvej 30, Frederiksberg 1958, Denmark;3. DuPoint Nutrition and Health, Active Nutrition, Sokeritehtaantie 20, Kantvik 02460, Finland |
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| Abstract: | Given the relatively immature state of the neonatal gut and gut-associated immune system, the safety of probiotic strains for use as ingredients in infant milk formulae must be demonstrated in infant populations. As part of a double-blind placebo-controlled clinical trial of two commercially available probiotic strains in the reduction of risk for infant eczema, a number of safety outcomes were measured. Infants received daily doses of Lactobacillus rhamnosus HN001 (6 × 109 cfu day?1) or Bifidobacterium animalis subsp. lactis HN019 (9 × 109 cfu day?1), or placebo from birth to 24 months. Mothers received the same treatment from 35 weeks gestation, for up to 6 months postnatally while breastfeeding. No statistically significant differences were observed between the treatment groups for study withdrawal, incidence of adverse events, morphometric data, wheeze, and antibiotic use over the treatment period. We conclude that probiotics strains HN001 and HN019 were safe and well tolerated in infants, and did not affect normal growth. |
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