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

Main Article Content

Reni Suryanty
Supriatmo Supriatmo
Berlian Hasibuan
Atan Baas Sinuhaji

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

Article Details

How to Cite
1.
Suryanty R, Supriatmo S, Hasibuan B, Sinuhaji A. Efficacy of fructooligosaccharide versus placebo for treatment of acute diarrhea in children: A double-blind randomized clinical trial. PI [Internet]. 10Oct.2016 [cited 19Jul.2019];45(2):65-. Available from: https://paediatricaindonesiana.org/index.php/paediatrica-indonesiana/article/view/802
Section
Articles
Author Biographies

Reni Suryanty

Department of Child Health, Medical School, University of
Sumatera Utara, Medan, Indonesia.

Supriatmo Supriatmo

Department of Child Health, Medical School, University of
Sumatera Utara, Medan, Indonesia.

Berlian Hasibuan

Department of Child Health, Medical School, University of
Sumatera Utara, Medan, Indonesia.

Atan Baas Sinuhaji

Department of Child Health, Medical School, University of
Sumatera Utara, Medan, Indonesia.
Received 2016-10-05
Accepted 2016-10-05
Published 2016-10-10

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