Efficacy of fructooligosaccharide versus placebo for treatment of acute diarrhea in children: A double-blind randomized clinical trial

Abstract

Objective To compare the efficacy of fructooligosaccharide (FOS)
versus placebo in pediatric patients with acute diarrhea with re-
gard 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 dehy-
dration 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 dehy-
dration, 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 com-
pleted 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 con-
sistency 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