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Randomized, Double-Blind Clinical Trial of a Lactose-Free and a Lactose-Containing Formula in Dietary Management of Acute Childhood Diarrhea


Nipat Simakachorn MD*, Yothi Tongpenyai MD, MSc*,
Orapin Tongtan RN*, Wandee Varavithya MD**
* Department of Pediatrics, Maharat Nakhon Ratchasima Hospital, School of Medicine
** Department of Pediatrics, Faculty of Medicine, Ramathibodi Hospital, Mahidol University


Background : Refeeding of artificially fed infants with lactose-containing formula after oral rehydration
therapy in the treatment of acute diarrhea was concluded to be indifferent to non-lactose formula by a metaanalysis.
In Thai as well as Asian infants and children with low lactase level from genetically determinant
and with rotavirus infection, lactose malabsorption is most likely to occur and cause delayed recovery. The
aim of this study was to compare the effect of a lactose-free and a lactose-containing formula in dietary
management of acute childhood diarrhea.
Patients and Method : A randomized, double-blind clinical trial of 80 male children, formula-fed, aged 3 to
24 months, admitted with acute watery diarrhea and mild or moderate dehydration, was carried out. All
children received oral rehydration therapy for the first 4 hours. After appropriate rehydration, they were fed
either a lactose-free formula (Dumex ® Lactose-Free Formula; treatment group, n = 40) or a lactose-containing
formula (Dumex ® Infant Formula; control group, n = 40) in adjunction with oral rehydration solution.
In addition, the infants were fed rice gruel as tolerated. Comparisons of duration of diarrhea, weight gain,
vomiting, biochemical changes, stool frequency and weight and unscheduled intravenous fluid were made.
Results : Three children (2 treatment, and 1 control) dropped out from the study. The total number of
unscheduled intravenous infusions were 6 of 80 children (7.5%), including 2 (5.0%) in the treatment group
and 4 (10.0%) in the control group. Three children in the control group did not resolve from diarrhea within
7 days of treatment. Rotavirus was identified in approximately 50% of the children in each group. Using
survival analysis, the median duration of diarrhea was significantly shortened by 20.5 hours in the treatment
group compared to the control group (77.0 hours in the treatment group vs 97.5 hours in the control group;
P = 0.002). Significantly decrease in stool frequency and increase in percent weight gain were seen in the
treatment group at 24 hours. Moderate acidosis cleared up to near normal at 24 hours in the treatment group
but acidosis persisted in the control group. In the rotavirus diarrhea subgroup, moderate acidosis turned to
be mild in treatment group, but acidosis was unchanged with increased plasma chloride level in the control
at 24 hours thus suggesting that the children in the control group might have lactose malabsorption and
osmotic diarrhea. Duration of rotavirus diarrhea was shortened 23.6 hours in treatment group compared to
the control (P = 0.0034).
Conclusions : In this study, lactose-free formula was shown to be effective in the dietary management of acute
childhood diarrhea. Duration of diarrhea was shortened, weight gain was better, and stool frequency was
less when compared to lactose-containing formula. Moderate acidosis cleared up spontaneously at 24
hours. Unscheduled IV could be decreased by 50%. Children receiving lactose-free formula tolerated it well.
Data of subgroup analysis of rotavirus diarrhea revealed lactose-free formula scored higher than the control
group for all parameters studied.

Keyword : Acute diarrhea, Lactose-free formula, Oral rehydration therapy

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