Safety and adequacy of a semi-elemental formula for children with gastro-intestinal disease
Yvan Vandenplas
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Kathleen Plaskie
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Bruno Hauser
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Y. Vandenplas (&) K. Plaskie B. Hauser Department of Pediatrics, Universitair Ziekenhuis Brussel Kinderen
, Laarbeeklaan 101,
1090 Brussels, Belgium
A prospective, open trial was conducted to evaluate the nutritional adequacy of a semi-elemental diet in 47 children with functional gastro-intestinal disorders. Nutritional adequacy was assessed based on growth relative to Euro-growth standards for body mass index (BMI)-forage z-scores and evaluations of blood parameters. Twentyfive patients completed the study. In total, 533 l of ''New-Alfare'' was consumed during 775 trial-days. The mean intake per infant was 85.8 26.8 kcal/kg/day or 122.5 38.3 ml/kg/day. Weight and length evolution during the 4 weeks trial were within normal range. The mean BMI-for-age z-score (P 0.05) and albumin concentration (P 0.01) increased significantly after 4 weeks. Plasma threonine concentration decreased significantly (P = 0.01) and the tryptophan concentration increased (P = 0.06). No adverse events related to the study formula were reported. These results show that ''New Alfare'' is safe and nutritionally adequate for pediatric patients with gastrointestinal disease.
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Infants with enteropathy who cannot be breast-fed, are best
treated by replacing milk from their diet with alternative
formulas based on hydrolyzed proteins or on amino acids.
Hydrolyzed formulas have been shown to provide adequate
nutrition in asymptomatic, unselected, healthy infants
(Vandenplas et al. 1993; Exl et al. 2000). In one of these
studies, hydrolyzed formula was shown to promote normal
growth of healthy infants during at least the first 3 months
of life even though the mean caloric intake was lower than
that of infants fed on non-hydrolyzed formula (Vandenplas
et al. 1993). Concentrations of zinc, urea, and iron binding
capacity were also higher in infants fed on the hydrolyzed
formula (but within normal range), and all other blood
nutritional parameters were similar in the two groups
(Vandenplas et al. 1993).
On the other hand, in infants with enteropathy of
heterogeneous etiology, such as post-enteritis syndrome and cows
milk protein allergy (CMPA), the nutritional situation is
different. For instance, it has been shown that children with
CMPA ingest significantly smaller volumes of formula, and
therefore a lower intake of calories, protein and fat compared
to normal children (Tiainen et al. 1995). Consequently,
allergic children on elimination diets who are not fed
hydrolyzed formulas are significantly smaller than
nonallergic children (Tiainen et al. 1995; Christie et al. 2002).
Christie et al. showed that over a third of the children allergic
to two or more foods and on an elimination diet were smaller
than the 25th percentile for height-for-age, and more of these
infants consumed less than 67% of the dietary reference for
calcium, vitamin D and vitamin E, compared to healthy
infants (Christie et al. 2002). Because children with GI
diseases on an elimination diet are at an increased risk for
growth retardation, their nutritional intake has to be closely
monitored and formulas with sufficient supplementation of
nutrients with improved absorbability need to be provided.
In the current study, we evaluated the nutritional
adequacy and short-term safety of a formula for infants who
require enteral feeding. This formula is based on an
improved protein hydrolysis technique that generates an
amino acid profile that better resembles that of breast milk
(lower concentration of threonine) compared to the
previous formula (Alfare). It also contains nucleotides, which
are thought to have beneficial effects on the immune and
GI systems of infants (Yau et al. 2003; Carver 1999;
Brunser et al. 1994).
Subjects and methods
Study design and population
This was a prospective, open, 4-week, mono-center study
carried out in the Department of Pediatrics at the Universitair
Ziekenhuis Brussel (Brussels, Belgium). Inclusion criteria
were gestational age of C26 weeks, weighing C1,500 g, and
being B36 months old at the time of the study. Infants and
children that were hospitalized because of a variety of
symptoms of GI disease and required diagnostic workup and
nutritional treatment with a semi-elemental formula for at
least 1 month were eligible for inclusion. Patients who were
less than 1-year old were fed solely with the study formula
for 4 weeks, and for those older than 1 year the study
formula constituted C75% of the total caloric intake. Patients
who were expected to be fed exclusively through parenteral
route for longer than a month were not eligible.
Weight, length, and blood parameters were measured at
the beginning (day 0) and end (day 28 3) of the study.
Additional weight measurements were taken at weekly
intervals. Acceptability and tolerance (volume of formula
intake, GI symptoms, and stool characteristics) were
recorded daily by the parents.
This study was approved by the Ethical Committee (...truncated)