PMID- 28555502
OWN - NLM
STAT- MEDLINE
DCOM- 20180417
LR  - 20180417
IS  - 1876-2891 (Electronic)
IS  - 1876-2883 (Linking)
VI  - 8
IP  - 4
DP  - 2017 Aug 24
TI  - Safety and tolerance of three probiotic strains in healthy infants: a 
      multi-centre randomized, double-blind, placebo-controlled trial.
PG  - 569-578
LID - 10.3920/BM2017.0009 [doi]
AB  - Some strains of species belonging to the genera Bifidobacterium and Lactobacillus 
      are used in order to maintain health. Although these organisms have a long record 
      of safe use, it is important to assess their safety and tolerance in potentially 
      vulnerable populations, such as infants. The objective of this study was to 
      evaluate the safety and tolerance of three probiotic strains (Bifidobacterium 
      longum subsp. infantis R0033, Bifidobacterium bifidum R0071 and Lactobacillus 
      helveticus R0052) in healthy infants aged 3 to 12 months. A multi-centre 
      randomized, double-blind, placebo-controlled intervention study with 221 healthy 
      full-term infants was conducted. Infants received either a placebo or one of the 
      3 probiotic strains (3x10(9) cfu) daily during an 8 week intervention period. 
      Growth (weight, height and head circumference), adverse events (AEs)/serious 
      adverse events (SAEs), concentrations of D-lactic acid in urine samples, 
      characteristics of the stools and use of medication were collected for safety 
      evaluation. All 4 groups were homogeneous with respect to age, gender, feeding 
      type, ethnicity, height, weight and head circumference at the start of the study. 
      The results showed that changes in growth (weight, height and head circumference) 
      were equivalent in all 4 groups. No SAEs were reported. Total number of AEs 
      recorded was equivalent in all groups. Thus, the use of B. infantis R0033, L. 
      helveticus R0052 and B. bifidum R0071 in infancy is safe, and well tolerated.
FAU - Manzano, S
AU  - Manzano S
AD  - 1 Dpto. Nutricion, Bromatologia y Tecnologia de los Alimentos, Universidad 
      Complutense de Madrid, Av. Puerta de hierro s/n, 28040 Madrid, Spain.
AD  - 2 Probisearch S.L.U., C/ Santiago Grisolia, 2, 28760 Tres Cantos, Spain.
FAU - De Andres, J
AU  - De Andres J
AD  - 1 Dpto. Nutricion, Bromatologia y Tecnologia de los Alimentos, Universidad 
      Complutense de Madrid, Av. Puerta de hierro s/n, 28040 Madrid, Spain.
FAU - Castro, I
AU  - Castro I
AD  - 1 Dpto. Nutricion, Bromatologia y Tecnologia de los Alimentos, Universidad 
      Complutense de Madrid, Av. Puerta de hierro s/n, 28040 Madrid, Spain.
FAU - Rodriguez, J M
AU  - Rodriguez JM
AD  - 1 Dpto. Nutricion, Bromatologia y Tecnologia de los Alimentos, Universidad 
      Complutense de Madrid, Av. Puerta de hierro s/n, 28040 Madrid, Spain.
AD  - 2 Probisearch S.L.U., C/ Santiago Grisolia, 2, 28760 Tres Cantos, Spain.
FAU - Jimenez, E
AU  - Jimenez E
AD  - 1 Dpto. Nutricion, Bromatologia y Tecnologia de los Alimentos, Universidad 
      Complutense de Madrid, Av. Puerta de hierro s/n, 28040 Madrid, Spain.
AD  - 2 Probisearch S.L.U., C/ Santiago Grisolia, 2, 28760 Tres Cantos, Spain.
FAU - Espinosa-Martos, I
AU  - Espinosa-Martos I
AD  - 1 Dpto. Nutricion, Bromatologia y Tecnologia de los Alimentos, Universidad 
      Complutense de Madrid, Av. Puerta de hierro s/n, 28040 Madrid, Spain.
AD  - 2 Probisearch S.L.U., C/ Santiago Grisolia, 2, 28760 Tres Cantos, Spain.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20170530
PL  - Netherlands
TA  - Benef Microbes
JT  - Beneficial microbes
JID - 101507616
SB  - IM
MH  - Bifidobacterium/*physiology
MH  - Bifidobacterium bifidum/*physiology
MH  - Body Height
MH  - Body Weight
MH  - *Child Development
MH  - Double-Blind Method
MH  - Feces/microbiology
MH  - Female
MH  - Head/growth & development
MH  - Humans
MH  - Infant
MH  - Infant Health
MH  - Lactobacillus helveticus/*physiology
MH  - Male
MH  - Probiotics/*administration & dosage/adverse effects
OTO - NOTNLM
OT  - clinical trial
OT  - healthy infants
OT  - probiotics
OT  - safety and tolerance
EDAT- 2017/05/31 06:00
MHDA- 2018/04/18 06:00
CRDT- 2017/05/31 06:00
PHST- 2017/05/31 06:00 [pubmed]
PHST- 2018/04/18 06:00 [medline]
PHST- 2017/05/31 06:00 [entrez]
AID - 10.3920/BM2017.0009 [doi]
PST - ppublish
SO  - Benef Microbes. 2017 Aug 24;8(4):569-578. doi: 10.3920/BM2017.0009. Epub 2017 May 
      30.