A prospective, double-blind, placebo-controlled study was performed. Ninety-eight children admitted with acute gastroenteritis were enrolled and randomly assigned to groups A (treated) and B (control). Children in group A received a single oral dose of 300 mg/kg body weight of human serum immunoglobulin. Parameters of efficacy were clinical condition, frequency and consistency of stools, duration of diarrhea, duration of viral excretion, and length of hospital stay. Antirotaviral activity was determined in the immunoglobulin preparation by a specific neutralization assay.Results
Seventy-one of the 98 children enrolled had rotaviral gastroenteritis; 36 belonged to group A. Children who received immunoglobulin had significantly faster clinical improvement of clinical condition and stool pattern than control children. Mean total duration of rotaviral diarrhea was 76 hours in group A and 131 in group B (P < .01). Viral excretion lasted 114 and 180 hours, respectively (P < .01). Hospital stay was significantly reduced in children in group A. Neutralizing antibodies against rotavirus were detected in the immunoglobulin preparation.Conclusion
Oral administration of immunoglobulin is associated with a faster recovery from acute gastroenteritis and should be given to children hospitalized with this illness. Pediatrics 1994;93:12-16; immunoglobulin, gastroenteritis, rotavirus, diarrhea.