Chemistry Reference
In-Depth Information
infants was specifically assessed. Clinical trials in preterm infants were mainly
focused on reducing the risk of NEC, in general showing no serious adverse events
and no difference in risk of sepsis between the probiotic and control group.
230
In a
small trial, the clinical safety of
L . casei
Shirota in critically ill children aged 0.5 to
15.9 years was assessed. There was no evidence of either colonization or bacteremia
and the preparation was well tolerated with no apparent side effects.
231
In another
study, in which the effect of
L. rhamnosus
GG to reduce the incidence of nosoco-
mial infection in pediatric intensive care was studied, a trend toward an increase in
infection was seen and therefore the study was terminated prematurely.
232
Indeed,
more studies would be needed to study safety of probiotic bacteria in pediatric
critical care. The committee has fewer concerns on follow-on formulas designed
for infants older than 5 months because there is a more mature immune response,
an established intestinal colonization, and a history of exposure to organisms from
the environment.
15.4.4.1 Systemic Infections
Lactobacilli and bifidobacteria are generally regarded as safe, they are sup-
posed to have low pathogenicity, and they are seldom detected in blood culture.
Bifidobacteria are among the first microbes to colonize the gastrointestinal tract of
newborn infants. They are usually transmitted by the mother and the surrounding
environment.
233,234
Bifidobacteria are present as the predominant bacteria in the
intestinal tract of breastfed infants
31,95,158
and are considered to contribute to the
health of infants. Cases of infections by bifidobacteria are considered extremely
rare and are mostly resolved by antibiotic treatment.
235-237
Lactobacilli are natu-
ral commensals of the gastrointestinal tract and are used worldwide as starter
cultures for dairy products. Lactobacilli have been associated with isolated cases
of clinical infections, such as bacteremia and endocarditis, mostly in sick people
with underlying conditions. The species
L . casei
and
L. rhamnosus
are most com-
monly isolated from infection sites.
238
A possible epidemiological link between
probiotic consumption and rise in clinical isolates of lactobacilli could not be
made.
239,240
Increased probiotic use of
L. rhamnosus
GG has not led to an increase
in
Lactobacillus
bacteremia.
248
However, several reports can be found in which
infections are directly linked to consumption of probiotic products mostly using
L
.
rhamnosus
GG.
240-245
Two pediatric patients, one 6-week-old term patient and
one 6-year-old patient receiving probiotic
lactobacilli, subsequently developed
bacteremia and sepsis
attributable to
Lactobacillus
species. The isolates were
indistinguishable from LGG as determined by rep-PCR.
246
Two other cases of
Lactobacillus
septicemia were reported in two infants of 34- and 36-week ges-
tation with short bowel syndrome. Both infants were treated with Culturelle
®
,
containing
L. rhamnosus
GG, for its antidiarrheal effects. In one infant it was
confirmed by DNA fingerprinting (PFGE) that the supplemented strain was indis-
tinguishable from the blood culture isolate.
243,245
These cases show that although
the beneficial effects of probiotic agents for infants are well
documented, probiotic
therapy may be associated occasionally
with adverse effects, such as bacteremia,
