Oral Human Immunoglobulin for Children with Autism and Gastrointestinal Dysfunction: A Prospective, Open-Label Study

Abstract

Immunoglobulin secretion onto mucosal surfaces is a major component of the mucosal immune system. We hypothesized that chronic gastrointestinal (GI) disturbances associated with autistic disorder (AD) may be due to an underlying deficiency in mucosal immunity, and that orally administered immunoglobulin would be effective in alleviating chronic GI dysfunction in these individuals. In this pilot study, twelve male subjects diagnosed with AD were evaluated using a GI severity index (GSI) while receiving daily dosing with encapsulated human immunoglobulin. Following eight weeks of treatment, 50% of the subjects met prespecified criteria for response in GI signs and symptoms and showed significant behavioral improvement as assessed by the Autism Behavior Checklist and parent and physician rated Clinical Global Impression of Improvement.

A Double-Blind, Placebo-Controlled Trial of Oral Human Immunoglobulin for Gastrointestinal Dysfunction in Children with Autistic Disorder

“…This was primarily due to the large improvement in the placebo group Sandler et al 2000). A prospective, open-label, pilot study of oral, human immunoglobulin demonstrated potential as a possible treatment for children with GI dysfunction associated with autism who had failed traditional medical treatment (Schneider et al 2006). Based upon those preliminary results, this large, randomized, placebo-controlled trial was conducted to examine the effects of oral immunoglobulin in subjects with GI dysfunction and autism.…”

“…Patients unable to swallow capsules were allowed to open the capsules and sprinkle the powder in liquid or on food. The dosing was based on results from an uncontrolled pilot study (Schneider et al 2006) showing what appeared to be some efficacy and a sustained effect with a 420 mg/day dose of IGOH. A review of the literature suggested that we could expect up to 70% of the IGOH to survive functional and intact through the GI tract.…”

“…Oral immunoglobulin appears to be well-tolerated with no serious side effects reported in low birth weight neonates (Barnes et al 1982), children and adults with serious intestinal infections (Borowitz and Saulsbury 1991;Guarino et al 1994;Losonsky et al 1985;Tacket et al 1988;1992;Tjellstrom et al 1993Tjellstrom et al , 1997, and in healthy adult volunteers (Bogstedt et al 1995). Schneider et al (2006) previously conducted an 8 week prospective open-label pilot study using oral immunoglobulin (Oralgam) in 12 children with autism and persistent GI dysfunction. Nine of 12 subjects completed the pilot study.…”

Potential for Early-Life Immune Insult Including Developmental Immunotoxicity in Autism and Autism Spectrum Disorders: Focus on Critical Windows of Immune Vulnerability

“…These authors suggested that several environmental factors may trigger the autoimmunity seen in children with autism. Schneider et al (2006) found some improvement in chronic GI dysfunction in autistic patients when immunoglobulin was administered orally. The authors postulated that the oral administration of immunoglobulin helped to address an underlying deficiency in the mucosal immunity in these autistic individuals.…”

Immunological Dysfunction in Autism Spectrum Disorder: A Potential Target for Therapy

“…Schneider et al [102] administered oral immunoglobulin in a pilot study with 12 male ASD subjects, considering the chronic GI disturbances in ASD due to an underlying deficiency in mucosal immunity. By the fourthweek assessment, 50% of subjects had improvements in GI symptoms.…”