Lactobacillus fermentum CECT 5716 and a reduction of the Staphylococcus load in breast milk which reduces the risk of infectious mastitis: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006

Human breast milk has been described as a source of lactic acid bacteria. Lactobacillus fermentum CECT5716 is a human breast milk strain whose probiotic properties, safety and efficacy has been demonstrated in vitro and in vivo, including controlled trials with human adults. Since the origin of this probiotic strain is human breast milk, we aimed to investigate the safety and efficacy of an infant and a follow-on formulas supplemented with this strain of L. fermentum. We carried out two randomised controlled trials: one trial with infants of 6-12 months of age (follow-on formula study) and another one with infants from 1 to 5 months of age (infant formula study). The results from the trials showed that the probiotic formulas were safe, well tolerated and might be useful for the prevention of community-acquired infections.

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Oral Administration of Lactobacillus Strains Isolated from Breast Milk as an Alternative for the Treatment of Infectious Mastitis during Lactation

Applied and Environmental Microbiology ◽

10.1128/aem.02599-07 ◽

2008 ◽

Vol 74 (15) ◽

pp. 4650-4655 ◽

Cited By ~ 119

Author(s):

E. Jiménez ◽

L. Fernández ◽

A. Maldonado ◽

R. Martín ◽

M. Olivares ◽

...

Keyword(s):

Breast Milk ◽

Clinical Signs ◽

Control Group ◽

Control Groups ◽

Lactobacillus Salivarius ◽

Probiotic Group ◽

Efficient Alternative ◽

The Mean ◽

And Control ◽

Infectious Mastitis

ABSTRACT In this study, 20 women with staphylococcal mastitis were randomly divided in two groups. Those in the probiotic group daily ingested 10 log10 CFU of Lactobacillus salivarius CECT5713 and the same quantity of Lactobacillus gasseri CECT5714 for 4 weeks, while those in the control one only ingested the excipient. Both lactobacillus strains were originally isolated from breast milk. On day 0, the mean staphylococcal counts in the probiotic and control groups were similar (4.74 and 4.81 log10 CFU/ml, respectively), but lactobacilli could not be detected. On day 30, the mean staphylococcal count in the probiotic group (2.96 log10 CFU/ml) was lower than that of the control group (4.79 log10 CFU/ml). L. salivarius CECT5713 and L. gasseri CECT5714 were isolated from the milk samples of 6 of the 10 women of the probiotic group. At day 14, no clinical signs of mastitis were observed in the women assigned to the probiotic group, but mastitis persisted throughout the study period in the control group women. In conclusion, L. salivarius CECT5713 and L. gasseri CECT5714 appear to be an efficient alternative for the treatment of lactational infectious mastitis during lactation.

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Bacterial Analysis of Breast Milk: A Tool to Differentiate Raynaud’s Phenomenon from Infectious Mastitis During Lactation

Current Microbiology ◽

10.1007/s00284-009-9393-z ◽

2009 ◽

Vol 59 (1) ◽

pp. 59-64 ◽

Cited By ~ 14

Author(s):

Susana Delgado ◽

M. Carmen Collado ◽

Leonides Fernández ◽

Juan M. Rodríguez

Keyword(s):

Breast Milk ◽

Raynaud’S Phenomenon ◽

Raynaud's Phenomenon ◽

Infectious Mastitis

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Lactobacillus fermentum CECT5716 – prevention and treatment of lactational mastitis

Medical Council ◽

10.21518/2079-701x-2019-13-70-72 ◽

2019 ◽

pp. 70-72

Author(s):

A. О. Karapetyan

Keyword(s):

Lactic Acid ◽

Breast Milk ◽

Pathogenic Bacteria ◽

Postnatal Period ◽

Lactobacillus Fermentum ◽

Inflammatory Factors ◽

Prevention And Treatment ◽

Lactational Mastitis ◽

Scopus Database

Aim of the study: To present an analysis of the literature data on the role of Lactobacillus fermentum CECT5716 in the prevention and treatment of postpartum lactation complications. Materials and methods: literature sources published in the Pubmed, Scopus database were searched. Results: according to randomized clinical studies, the use of Lactobacillus fermentum CECT5716 in the postnatal period by mothers leads to the correction of breast microbiota by reducing the number of pathogenic bacteria and increasing lactic-acid bacteria, reducing the content of inflammatory factors in breast milk. Conclusion: Lactobacillus fermentum CECT5716 is an effective and safe way to prevent and treat postpartum lactation complications.

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In vitro immunomodulatory activity of two probiotic strains isolated from human breast milk: Lactobacillus salivarius CECT5713 and Lactobacillus fermentum CECT5716

Proceedings of The Nutrition Society ◽

10.1017/s0029665110000315 ◽

2010 ◽

Vol 69 (OCE3) ◽

Author(s):

F. J. Pérez-Cano ◽

P. Yaqoob

Keyword(s):

Breast Milk ◽

Lactobacillus Fermentum ◽

Immunomodulatory Activity ◽

Human Breast Milk ◽

Human Breast ◽

Lactobacillus Salivarius ◽

Probiotic Strains

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In vitro immunomodulatory activity of Lactobacillus fermentum CECT5716 and Lactobacillus salivarius CECT5713: two probiotic strains isolated from human breast milk

Immunobiology ◽

10.1016/j.imbio.2010.01.004 ◽

2010 ◽

Vol 215 (12) ◽

pp. 996-1004 ◽

Cited By ~ 87

Author(s):

Francisco J. Pérez-Cano ◽

Honglin Dong ◽

Parveen Yaqoob

Keyword(s):

Breast Milk ◽

Lactobacillus Fermentum ◽

Immunomodulatory Activity ◽

Human Breast Milk ◽

Human Breast ◽

Lactobacillus Salivarius ◽

Probiotic Strains

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Faculty Opinions recommendation of Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.4324978.4144081 ◽

2010 ◽

Author(s):

Bryan Larsen

Keyword(s):

Breast Milk ◽

Oral Administration ◽

Infectious Mastitis

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Effects of Lactobacillus fermentum CECT5716 Lc40 on infant growth and health: a randomised clinical trial in nursing women

Beneficial Microbes ◽

10.3920/bm2019.0180 ◽

2020 ◽

Vol 11 (3) ◽

pp. 235-244

Author(s):

B. Pastor-Villaescusa ◽

J.A. Hurtado ◽

M. Gil-Campos ◽

J. Uberos ◽

J.A. Maldonado-Lobón ◽

...

Keyword(s):

Breast Milk ◽

Multicentre Trial ◽

Respiratory Infections ◽

Randomised Clinical Trial ◽

Infant Growth ◽

Lactobacillus Fermentum ◽

Control Group ◽

Z Score ◽

The Us ◽

Double Blinded

The breast milk microbiota has been described as a source of bacteria for infant gut colonisation. We studied the effect of Lactobacillus fermentum CECT5716 (Lc40) on growth and infection incidence of the infants, when the probiotic is administrated to the mothers. Moreover, whether such effects might depend on the interaction between the mother or infant microbiota and the probiotic administration. A total of 291 mother-infant pairs were studied for 16 weeks in a randomised double-blinded placebo-controlled multicentre trial. The Lc40 group (n=139) received 1 capsule/day containing 3×109 cfu Lc40; the control group (n=152) received 1 placebo (maltodextrin) capsule/day. A positive and significant correlation of the Staphylococcus load between breast milk and infant faeces was only observed in control group. Additionally, the weight z-score of the infants whose mothers had higher values of Lactobacillus in their breast milk were significantly higher for the Lc40 group. We observed a significant lower incidence of conjunctivitis in the infants whose mothers received Lc40. A higher load of Staphylococcus in infant faeces significantly increased the risk of respiratory infections. Such incidence, under an absent or low Staphylococcus load in the faeces, was significantly 36 times higher in the infants in the control group than in the infants in the Lc40 group. However, the protective effect of Lc40 was gradually reduced as the Staphylococcus load of the milk increased. The administration of Lc40 to nursing women might influence infant growth and health but it seems to depend on its interactions with mother or infant microbiota. Registered in the US Library of Medicine ( www.clinicaltrials.gov ): NCT02203877.

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