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

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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.

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Acknowledgments

The authors would like to thank the subjects and parents for their participation in the study, the Southwest Autism Research and Resource Center for making its facility available during the study, and Janet Kirwan, RN and Monica McCabe, RN, OCN for their skill and dedication in ensuring that the study was conducted in compliance with the study protocol and regulatory guidelines. Funding for the study was provided by Protein Therapeutics, Inc.

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Author notes

  1. Cindy K. Schneider

    Present address: Center for Autism Research & Education, Phoenix, AZ, USA

  2. James A. Ostrem

    Present address: ImaRx Therapeutics, Inc.,, Tucson, AZ, USA

  3. F. Javier Enriquez

    Present address: UCB Clinical Development, Smyrna, GA, USA

Authors and Affiliations

  1. Southwest Autism Research and Resource Center, Phoenix, AZ, USA

    Cindy K. Schneider & Raun D. Melmed

  2. Protein Therapeutics, Inc.,, Tucson, AZ, USA

    Leon E. Barstow, F. Javier Enriquez & James A. Ostrem

  3. Cancer Center Biometry Unit, University of Arizona Health Sciences Center, University of Arizona, Tucson, AZ, USA

    James Ranger-Moore

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  1. Cindy K. Schneider
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  2. Raun D. Melmed
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Correspondence to James A. Ostrem.

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Schneider, C.K., Melmed, R.D., Barstow, L.E. et al. Oral Human Immunoglobulin for Children with Autism and Gastrointestinal Dysfunction: A Prospective, Open-Label Study. J Autism Dev Disord 36, 1053–1064 (2006). https://doi.org/10.1007/s10803-006-0141-y

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  • DOI: https://doi.org/10.1007/s10803-006-0141-y

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