Feb. 5, 2004 — Probiotic-supplemented infant formula is well tolerated and
safe, according to the results of a randomized, double-blind, placebo-
controlled trial published in the February issue of the American Journal of
Clinical Nutrition. Furthermore, treated infants had a lower rate of colic
and use of antibiotics.

"Nonpathogenic live bacteria are consumed as food by many children,
particularly in the form of yogurt," write Jose M. Saavedra, from the Johns
Hopkins University School of Medicine in Baltimore, Maryland, and
colleagues. "The tolerance and safety of long-term consumption of specific
types and strains of probiotic bacteria are not well documented....
Adequate documentation of safety with prolonged use in infants is mandatory
if recommendations for use are to be made in this population."

In this prospective study, 118 healthy infants aged three to 24 months were
randomized to receive one of three standard milk-based formulas: formula
containing 1 x 107 colony-forming units (CFU)/g each of Bifidobacterium
lactis and Streptococcus thermophilus, formula containing 1 x 106 CFU/g
each of B. lactis and S. thermophilus, or unsupplemented formula.

At enrollment, mean age was 7.0 ± 2.9 months; the groups were similar in
age, sex, and duration of formula consumption (mean, 210 ± 127 days).
Compared with the unsupplemented formula, the supplemented formulas were
well accepted and were associated with a lower frequency of reported colic
or irritability (P < .001) and of antibiotic use (P < .001). Growth,
utilization of healthcare services, daycare absenteeism, and other health
variables were similar between groups.

"To our knowledge, this is the first careful documentation of intake of
live bacteria over any extended period of time in any population. The
intakes studied can be used as a benchmark for well-tolerated, safe intake
of these bacterial agents," the authors write. "Long-term consumption of
formulas supplemented with B. lactis and S. thermophilus was well tolerated
and safe and resulted in adequate growth, reduced reporting of colic or
irritability, and a lower frequency of antibiotic use."

Nestlé USA supported this study and provided formulas.

Am J Clin Nutr. 2004;79:261-267

Learning Objectives
Upon completion of this activity, participants will be able to:
List the conditions that have been shown to benefit from the use of
probiotic agents.
Describe the safety and advantages of the use of probiotic agents in a
generalized cohort of young children.
Clinical Context
Probiotic agents are nonpathogenic live bacteria ingested for their
positive effects on health. Recently, these agents have been studied in
reducing symptoms associated with atopic eczema. In the November 2000 issue
of Clinical and Experimental Allergy, Isolauri and colleagues demonstrated
a reduction in symptom scores in infants with eczema after ingesting either
B. lactis or Lactobacillus strain GG for two months.

Research has also supported probiotic agents' efficacy in reducing symptoms
of infectious diarrhea in children. In a randomized, placebo-controlled
study of 43 nonhospitalized children in daycare with acute diarrhea,
Rosenfeldt and colleagues showed that Lactobacillus species dosed twice a
day for five days decreased the number of hours with diarrhea by 20% (82
hours vs. 101 hours for the control group). Their results, which appeared
in the May 2002 issue of the Pediatric Infectious Diseases Journal, found
that the benefit was only enhanced if the treatment was started early. For
those receiving treatment after less than 60 hours of diarrhea, diarrhea
persisted a mean of 78.8 hours in the Lactobacillus group vs. 138.9 hours
in the control group. In addition to these positive results, the authors of
the current study cite probiotics as helpful in patients with Clostridium
difficile colitis and antibiotic-associated diarrhea.

The Rosenfeldt study reported one adverse event (constipation) that may
have been linked to the five-day treatment with Lactobacillus. However, no
prospective, randomized trial has examined the impact of probiotic agents
over time in young children. The authors of the current study designed a
research protocol to do precisely that.

Study Highlights
All study subjects were aged between 3 and 24 months of age and attended
daycare centers in Baltimore, Maryland. Children were excluded from study
participation if they breast-fed 3 or more times per day, had a formula
allergy, or had a history of chronic diarrhea or malabsorption.
Participants received 1 of 3 formulas: a standard milk-based formula, the
same formula supplemented with B. lactis and S. thermophilus at a
concentration of 1 x 107 CFU/g (high-supplement [HS] formula), or the same
formula supplemented with 1 x 106 CFU/g of the same two bacteria (low-
supplement [LS] formula). Subjects were required to ingest at least 240 mL
of their assigned formula per day. The study was not blinded.
Weekly phone calls to parents tracked adherence to the assigned group,
information on general health status, gastrointestinal symptoms, and
dietary information. Monthly height and weight were also measured.
131 infants were recruited into the study, and 13 did not complete the
study protocol. 9 of those who withdrew were from the supplementation
groups, and 4 were from the standard formula group.
Mean age at study entry was 6.7 months. The mean number of subject-days of
study was 209. There were no significant differences between the 3 groups
in terms of length or height at study entry.
51 participants were still taking their assigned formula at the end of the
study period. Of the 67 who had stopped the formula, 42 had been naturally
weaned off formula, and 6 had stopped because of perceived ill effects or
intolerance of the formula.
Mean formula consumption per subject was 762 mL/day, and formula
consumption did not differ significantly among the 3 groups. This
translated to a mean total bacterial consumption of 9.7 x 107 CFU/kg for
the LS group and 1.3 x 109 CFU/kg for the HS group.
There were no significant differences among the different treatment groups
in growth (height or weight) during the study period.
Episodes of loose stools and fever with loose stools were similar among all
treatment groups. Scores for discomfort with bowel movement were also
similar. However, scores for colic or irritability as well as the use of
antibiotics were significantly improved in the two supplement groups
compared with the standard formula group. There were no significant
differences for any variables between the HS and LS groups.
Healthcare attention for illness and daycare absenteeism were not improved
with formula supplements.

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