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Assessment of Infant Formula and Follow-on Formula Supplemented with Lactobacillus fermentum CECT5716

Jørgen Lassen, Siamak Yazdankhah, Judith Narvhus

European Journal of Nutrition & Food Safety · pp. 88–89 · Published 26 Dec 2014

10.9734/EJNFS/2015/14817

Abstract

The Norwegian Scientific Commitee for Food Safety (VKM) has appointed a working group of experts to answer a request from the Norwegian Food Safety Authority regarding risk assessment of Lactobacillus fermentum CECT5716 in infant formula intended for use from birth (0 month) and in infant formulae and follow-on formulae intended for children after the age of 6 month. The mandate of this risk assessment was not to evaluate the health claims related to the products as such health claims are assessed by EFSA. However, in the EFSA opinions so far (November 2009), a cause and effect relationship has not been established between the consumption of L. fermentum CECT5716 containing products and the claimed effects. In the assessment of L. fermentum CECT5716 by the expert committee in EFSA, the panel considered that the strain is sufficiently characterized. We are not aware of any data indicating that this strain has been the cause of human disease. Its potential toxicity and ability to translocate has been studied in adult mice after oral administration of doses 10 000 times greater than those normally consumed by humans without observing any bacteremia or translocation to spleen or liver. However, strains of Lactobacillus have from time to time been isolated from human blood cultures and may therefore, although seldom, translocate. L. fermentum CECT5716 is fully susceptible to all antibiotics that are recommended by the Panel on additive and products or substances used in animal feed (FEEDAP) of EFSA and is considered safe with respect to absence of antimicrobial resistance genes. DNA-sequence data do not imply the presence of any gene(s) coding for toxin production, but confirming in vitro-studies are missing. The FBO refers to two randomized clinical studies in healthy infants of 1-6months of age with respect to possible safety aspects, concluding that the L. fermentum CECT5716 was well tolerated and safe for the groups examined. However, data concerning safety aspects specifically concerned with new-borns, or for immunocompromised infants are lacking. The FBO has submitted some data regarding possible long-term adverse effects of giving the strain daily as a “monoculture” over a prolonged period of time. These data are not sufficient to draw any conclusion regarding long-term safety of the strain. It is supposed that the early composition of the human gastro-intestinal tract microbiota can have long-lasting functional effects. If that is the case, a daily supply of a “monoculture” of a single, specific strain such as L. fermentum CECT 5716, in large quantities over a prolonged period of time to age groups where the intestinal flora is still developing may therefore have unknown, but possible long-lasting adverse effects.

VKM Norwegian scientific committee for food safety probiotic Lactobacillus fermentum baby food infant.

References (36)

  1. 1 Guidelines for the evaluation of probiotics in food
  2. 2 Antagonistic activities of lactobacilli and bifidobacteria against microbial pathogens [DOI]
  3. 3 The human milk microbiota: Origin and potential roles in health and disease [DOI]
  4. 4 Human milk is a source of lactic acid bacteria for the infant gut [DOI]
  5. 5 Supplementation of Infant Formula With Probiotics and/or Prebiotics: A Systematic Review and Comment by the ESPGHAN Committee on Nutrition [DOI]
  6. 6 Scientific Opinion on the essential composition of infant and follow-on formulae [DOI]
  7. 7 Antimicrobial susceptibilities of Lactobacillus, Pediococcus and Lactococcus human isolates and cultures intended for probiotic or nutritional use [DOI]
  8. 8 Aberrant composition of gut microbiota of allergic infants: a target of bifidobacterial therapy at weaning? [DOI]
  9. 9 Establishment and development of lactic acid bacteria and bifidobacteria microbiota in breast-milk and the infant gut [DOI]
  10. 10 Probiotic Potential of 3 Lactobacilli Strains Isolated From Breast Milk [DOI]
  11. 11 Microbial ecology and host-microbiota interactions during early life stages [DOI]
  12. 12 The commensal microflora of human milk: new perspectives for food bacteriotherapy and probiotics [DOI]
  13. 13 Human Milk Probiotic Lactobacillus fermentum CECT5716 Reduces the Incidence of Gastrointestinal and Upper Respiratory Tract Infections in Infants [DOI]
  14. 14 Antimicrobial potential of four Lactobacillus strains isolated from breast milk [DOI]
  15. 15 Phenotypic and genotypic analyses of lactic acid bacteria in local fermented food, breast milk and faeces of mothers and their babies [DOI]
  16. 16 Gastrointestinal function development and microbiota [DOI]
  17. 17 The importance of the development of the intestinal microbiota in infancy [DOI]
  18. 18 Carbohydrate preference, acid tolerance and bile tolerance in five strains of Bifidobacterium [DOI]
  19. 19 Bacterial colonization and gut development in preterm neonates [DOI]
  20. 20 Lactobacillus casei Abundance Is Associated with Profound Shifts in the Infant Gut Microbiome [DOI]
  21. 21 Effect of Probiotics and Breastfeeding on the Bifidobacterium and Lactobacillus/Enterococcus Microbiota and Humoral Immune Responses [DOI]
  22. 22 Probiotic administration and the incidence of nosocomial infection in pediatric intensive care: A randomized placebo-controlled trial* [DOI]
  23. 23 Effects of Oral Lactobacillus GG on Enteric Microflora in Low-Birth-Weight Neonates [DOI]
  24. 24 Influence of fermentation time, cryoprotectant and neutralization of cell concentrate on freeze-drying survival, storage stability, and acid and bile exposure of Bifidobacterium animalis ssp. lactis cells produced without milk-based ingredients [DOI]
  25. 25 Lactobacillus fermentum CECT 5716 is safe and well tolerated in infants of 1–6 months of age: A Randomized Controlled Trial [DOI]
  26. 26 Current level of consensus on probiotic science-Report of an expert meeting- London, 23 November 2009 [DOI]
  27. 27 Long‐term Colonization of a Lactobacillus plantarum Synbiotic Preparation in the Neonatal Gut [DOI]
  28. 28 Probiotic Intervention in the First Months of Life [DOI]
  29. 29 Supplementation with Probiotics in the First 6 Months of Life Did Not Protect against Eczema and Allergy in At-Risk Asian Infants: A 5-Year Follow-Up [DOI]
  30. 30 Prenatal administration of Lactobacillus rhamnosus has no effect on the diversity of the early infant gut microbiota [DOI]
  31. 31 Preliminary technological and potential probiotic characterisation of bifidobacteria isolated from breast milk for use in dairy products [DOI]
  32. 32 The effect of Lactobacillus rhamnosus GG supplemented enteral feeding on the microbiotic flora of preterm infants-double blinded randomized control trial [DOI]
  33. 33 Complete Genome Sequence of Lactobacillus salivarius CECT 5713, a Probiotic Strain Isolated from Human Milk and Infant Feces [DOI]
  34. 34 Safety Assessment ofLactobacillus fermentumCECT5716, a probiotic strain isolated from human milk [DOI]
  35. 35 Changes in Gut Microbiota in Children with Atopic Dermatitis Administered the Bacteria Lactobacillus casei DN – 114001 [DOI]
  36. 36 The use of probiotics for critically ill patients in hospitals [DOI]

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