Objective. Preliminary evidence has been reported on the antirotavirus
effect of human serum immunoglobulin administered orally. The aim was
to see whether such treatment might be effective in rotavirus acute g
astroenteritis. Methods. A prospective, double-blind, placebo-controll
ed study was performed. Ninety-eight children admitted with acute gast
roenteritis were enrolled and randomly assigned to groups A (treated)
and B (control). Children in group A received a single oral dose of 30
0 mg/kg body weight of human serum immunoglobulin. Parameters of effic
acy were clinical condition, frequency and consistency of stools, dura
tion of diarrhea, duration of viral excretion, and length of hospital
stay. Antirotaviral activity was determined in the immunoglobulin prep
aration by a specific neutralization assay. Results. Seventy-one of th
e 98 children enrolled had rotaviral gastroenteritis; 36 belonged to g
roup A. Children who received immunoglobulin had significantly faster
clinical improvement of clinical condition and stool pattern than cont
rol children. Mean total duration of rotaviral diarrhea was 76 hours i
n group A and 131 in group B (P <.01). Viral excretion lasted 114 and
180 hours, respectively (P <.01). Hospital stay was significantly redu
ced in children in group A. Neutralizing antibodies against rotavirus
were detected in the immunoglobulin preparation. Conclusion. Oral admi
nistration of immunoglobulin is associated with a faster recovery from
acute gastroenteritis and should be given to children hospitalized wi
th this illness.