A double-blind, placebo-controlled trial of oral human immunoglobulin for gastrointestinal dysfunction in children with autistic disorder

Benjamin L. Handen, Raun D. Melmed, Robin L Hansen, Michael G. Aman, David L. Burnham, Jon B. Bruss, Christopher J. McDougle

Research output: Contribution to journalArticle

28 Scopus citations

Abstract

Controversy exists regarding the extent and possible causal relationship between gastrointestinal symptoms and autism. A randomized, double-blind, placebo-controlled, parallel groups, dose-ranging study of oral, human immunoglobulin (IGOH 140, 420, or 840 mg/day) was utilized with 125 children (ages 2-17 years) with autism and persistent GI symptoms. Endpoint analysis revealed no significant differences across treatment groups on a modified global improvement scale (validated in irritable bowel syndrome studies), number of daily bowel movements, days of constipation, or severity of problem behaviors. IGOH was well-tolerated; there were no serious adverse events. This study demonstrates the importance of conducting rigorous trials in children with autism and casts doubt on one GI mechanism presumed to exert etiological and/or symptomatic effects in this population.

Original languageEnglish (US)
Pages (from-to)796-805
Number of pages10
JournalJournal of Autism and Developmental Disorders
Volume39
Issue number5
DOIs
StatePublished - May 2009

Keywords

  • Autism
  • Gastrointestinal symptoms
  • Oral human immunoglobulin

ASJC Scopus subject areas

  • Developmental and Educational Psychology

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