Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism

Inclusion Criteria: Male or female from 2 years to 18 years of age (up to, but not inclusive of the 18th birthday) Diagnosis of autistic disorder corroborated by an Autism Diagnostic Interview - Revised (ADI-R) assessment performed by a certified investigator Physician Clinical Global Impression of Severity (of Autistic Disorder) History of chronic, persistent gastrointestinal disturbance No elective changes in medication, diet intervention, or behavioral therapy during the study (18 weeks total) Exclusion Criteria: Evidence of a gastrointestinal infection or GI abnormality A known diagnosis of other gastrointestinal pathology Antibiotic and/or antifungal (e.g. nystatin) medication Chelation therapy Medication affecting gastrointestinal transit Planned use of prohibited drugs or agents that could affect GI transit Changes in diet intervention within 30 days prior to the screening visit Changes in alternative medical therapies or dietary supplements within 30 days prior to the screening visit Adding and/or changing behavior modification or psychotherapy during participation in the study Adding or changing psychotropic medication during participation in the study DSM-IV diagnosis of a pervasive developmental disorder other than autistic disorder Evidence of a seizure disorder, diagnosis of fragile X syndrome, tuberous sclerosis complex, liver disease, pancreatic disease, cystic fibrosis, or chronic infection Previous gastrointestinal surgery Pregnancy Participation in another investigational study Significant deviation from normal laboratory test values at baseline IgA deficiency (serum IgA < 5 mg/dL) A history of severe hypersensitivity to human immunoglobulin Treatment with any human immunoglobulin and/or immunoglobulin products Any concurrent medication that would compromise subject's tolerance of drug or compliance with the protocol