Page 111 - 15Diarrhoeaandvomiting

Diarrhoea and vomiting caused by gastroenteritis in children under 5 years

6.2.4 The role of special milk formulas

Evidence overview
There were three RCTs that described lactose versus lactose-free cow’s milk feeds and three RCTs
comparing soy formula versus lactose-containing formula. One trial described soy formula in
early and late re-feeding and two trials compared cow’s milk formula versus a special formula.

Cow’s milk formula (lactose) versus treated cow’s milk formula (none or low lactose)
One trial enrolled 65 infants aged between 6 and 34 months (mean age 14.7 months) admitted
to a hospital in Finland with acute gastroenteritis and mild or moderate dehydration. Exclusion
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criteria were not presented. Following assessment and 6–10 hours’ ORT, children were randomised
to either a milk-containing diet (n = 38) or a milk-free diet (n = 27), and followed up for 3 days
and then at an outpatient appointment 1 month later. No details of the randomisation process
were given although it was stated that the allocation of interventions was not masked. The two
groups had similar characteristics at the start of the study. The authors reported significantly more
vomiting among the children receiving milk compared with those on a milk-free diet (P < 0.01).
Twelve children in the milk-free diet vomited a total of 24 times compared with four children
vomiting nine times in the milk-free group. There were no statistically significant differences
between the two groups in the duration of diarrhoea, length of hospital stay, weight gain or
episodes of diarrhoea in the following month. [EL = 1−]

One trial recruited 57 infants (age range 11–13 months) admitted to a Colombian hospital with
acute diarrhoea (more than four watery stools per day with a total duration of 1 week or less) and
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mild or moderate dehydration. Exclusion criteria were >50% milk intake from breastfeeding,
no use of lactose milk/formula prior to illness, diarrhoea caused by Entamoeba histolytica,
antibiotic therapy in the 48 hours prior to admission chronic malabsorption syndrome or refusal
of consent from parents. Children received IV and ORT and then were randomly assigned
(block randomisation to allow for age and nutritional state confounders) to either a lactose-free
(n = 29) or lactose formula (n = 28) group and followed up for 2 days. In both groups, following
rehydration, formula was administered in half-strength for 24 hours followed by full-strength
for the remaining 24 hours. The two groups had similar characteristics at the start of the study
except that the duration of diarrhoea prior to admission was significantly longer in children in
the lactose-free formula group (mean 3.5 days; SD 2.0 days) compared with the lactose formula
group (mean 2.3 days; SD 1.0 days). There were three treatment failures – one in the lactose-
free formula group and two in the lactose formula group. There were no statistically significant
differences between the two groups for either of the two outcome measures – mean duration of
diarrhoea and body weight increment. [EL = 1−]
Eighty male infants (age range 3–24 months) admitted to hospital with acute diarrhoea (duration
less than 7 days) and mild or moderate dehydration were recruited for a trial in Thailand. 134 Children
with mucous bloody stools, major systemic illness or third-degree malnutrition were excluded.
Children received ORT over 4 hours and then were randomly assigned (block randomisation,
coded identically packaged formula tins) to either the lactose-free (n = 40) or the lactose formula
(n = 40) group following appropriate rehydration, and followed up for 7 days. These formulas
were given in addition to ORS solution (after the first 4 hours) and infants were also fed rice gruel
as tolerated and appropriate to age. The two groups had similar characteristics at the start of the
study. There was a significant reduction in the duration of diarrhoea in the lactose-free group
compared with the lactose formula group (77 hours versus 97.5 hours; P = 0.002) and a greater
increase in the mean percentage weight in the lactose-free group at day 1 (1.5% ± 1.7% versus
0.3% ± 2.0%; P = 0.003). However, there were no statistically significant differences in weight
prior to or subsequent to this period. [EL = 1−]

Soy formula versus lactose-containing formula
Fifty-eight well-nourished infants (age range 3–18 months) admitted to hospital with acute
gastroenteritis and moderate or severe dehydration were enrolled in a trial in Egypt. 135 Children
with shigella, salmonella and pathogenic E. coli were excluded. IV rehydration therapy was
given prior to randomisation to either milk formula (lactose) (n = 29) or soy formula (lactose
free) (n = 29). No methodological details regarding randomisation or masking were given. The
follow-up period was 2–8 weeks and the main outcome measure was recurrence of diarrhoea.

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