Thought that you all would be interested in this abstract in Nutrition:
http://www.nutritionjrnl.com/article/PIIS0899900706003595/abstract
Clinical evaluation of a new starter formula for infants containing live
Bifidobacterium longum BL999 and prebiotics
Giuseppe Puccio, M.D.a, Cinzia Cajozzo, M.D.a, Ferdinando Meli, M.D.a,
Florence Rochat, Ph.D.b, Dominik Grathwohl, M.Sc.b, Philippe Steenhout, M.D.c
Abstract
Objectives
The larger number of bifidobacteria in the intestine of breast-fed infants has
been associated with their better health compared with formula-fed infants.
We assessed the safety and tolerability of an experimental formula containing
2 × 107 colony-forming units of Bifidobacterium longum BL999 and 4 g/L of a
prebiotic mixture containing 90% galacto-oligosaccharides and 10% fructo-
oligosaccharides.
Methods
A 7-mo prospective, randomized, reference-controlled, double-blinded trial
was performed in infants who were not breast fed after the 14th day of birth.
One hundred thirty-eight infants were enrolled and assigned to receive the
control or experimental formula until they were 112 d old. Mean weight gain
(primary outcome) and recumbent length, head circumference, tolerability
(gastrointestinal symptoms), and overall morbidity (secondary outcomes) were
measured at 14, 28, 56, 84, and 112 d of age.
Results
Equivalence in mean weight gain between the two groups was shown. The
treatment difference in the intention-to-treat and per-protocol populations
were within the predefined equivalence boundaries of ±3.9 g/d. No statistically
significant difference in recumbent length, head circumference, or incidence of
adverse events was found between the two groups. Infants in the
experimental group had fewer incidences of constipation and had stool
characteristics that suggest that the experimental formula was tolerated well.
Furthermore, these infants showed a trend toward fewer respiratory tract
infections.
Conclusions
The starter formula containing BL999 and galacto-oligosaccharides/fructo-
oligosaccharides is safe and well-tolerated.
Keywords: Bifidobacterium longum, Probiotics, Galacto-oligosaccharides/fructo-
oligosaccharides, Prebiotics, Infants, Formula, Safety
a Neonatology, Institute of Obstetrics and Gynecology, University of Palermo,
Palermo, Italy
b Nestlé Research Center, Lausanne, Switzerland
c Nestlé Nutrition, Nestec Ltd., Vevey, Switzerland
Corresponding author. Tel.: +39-091-655-2016; fax: +39-091-655-2042.
This study was sponsored by Nestlé Nutrition, Nestec Ltd., Vevey,
Switzerland.
PII: S0899-9007(06)00359-5
Why does it amaze/confuse me that parents would allow their babies to be
test subjects?
Ellen Penchuk, IBCLC, RLC
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