Efficacy of fructooligosaccharide versus placebo for treatment of acute deiarrhea in children: A double-blind randomized clinical trial
ABSTRACT: To compare the
efficacy of fructooligosaccharide (FOS) versus placebo in pediatric patients
with acute diarrhea with regard to duration and frequency of diarrhea and the
volume and consistency of the stools.
Methods This double-blind randomized clinical trial was carried out from
July to November 2003 in the pediatric intensive care unit, outpatient clinic,
and pediatric ward of Adam Malik Hospital and Pirngadi Hospital, Medan.
Subjects were children and infants aged 4 to 24 months suffering from acute
diarrhea without dehydration or with mild to moderate dehydration whose parents
gave consent. Children included in this trial received tablets of either 600 mg
FOS or 761 mg fructulin as placebo. Patients with mild to moderate dehydration
were initially rehydrated according to the WHO protocol. Afterwards, 10 tablets
of FOS or placebo were given to each subject to be taken twice daily. In
subjects without dehydration, the tablets were given by their parents. Daily
follow-up was performed, in which body weight, temperature, duration and
frequency of diarrhea, and the volume and consistency of stools were recorded.
For outpatients, home visits were made.
Results Out of 142 children who met inclusion criteria, 135 completed the
study. These consisted of 68 children in the FOS group and 67 in the placebo
group. Subjects were mostly <12 months of age (57.0%), male (57.8%), and
moderately malnourished (34.1%). There was no statistically significant
difference between both groups in the duration and frequency of diarrhea and
the volume and consistency of stools (P>0.05).
Conclusion There is no effect of the administration of FOS as
supplemental therapy on the duration and frequency of diarrhea and on the
volume and consistency of stools in children with acute diarrhea.
Author: Reni Suryanty, MD;
Supriatmo, MD; Berlian Hasibuan, MD; Atan Baas Sinuhaji, MD
Journal Code: jpkedokterangg050064
