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The Gluten-Free/Casein-Free Diet: A Double-Blind Challenge Trial in Children with Autism

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Abstract

To obtain information on the safety and efficacy of the gluten-free/casein-free (GFCF) diet, we placed 14 children with autism, age 3–5 years, on the diet for 4–6 weeks and then conducted a double-blind, placebo-controlled challenge study for 12 weeks while continuing the diet, with a 12-week follow-up. Dietary challenges were delivered via weekly snacks that contained gluten, casein, gluten and casein, or placebo. With nutritional counseling, the diet was safe and well-tolerated. However, dietary challenges did not have statistically significant effects on measures of physiologic functioning, behavior problems, or autism symptoms. Although these findings must be interpreted with caution because of the small sample size, the study does not provide evidence to support general use of the GFCF diet.

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Acknowledgments

The project described in this publication was funded by U54 MH066397 (NIH/NIMH Genotype and Phenotype of Autism, Principal Investigator: Patricia Rodier). It was also supported by the University of Rochester CTSA award UL1 RR024160 from the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. We thank the children and families who participated. We also thank Eileen Blakely, R.D., for assisting with nutritional monitoring; Emily Healy for assisting with data collection; Patricia Rodier, Ph.D. (deceased), for her leadership of the STAART Center; Caroline Magyar, Ph.D., and her staff for conducting intake assessments of participants; Christopher Stodgell, Ph.D., for directing data management of the project; and Loisa Bennetto, Ph.D., for her advice. We are grateful to the following agencies who referred participants to the study, participated in study implementation, and advised us: Stepping Stones Learning Center (Mariellen Cupini, Director; Dr. John McEachin, EIBI Consultant) and the Center for Autism and Related Disorders (Fairport, NY branch, Director: Denise Rhine; Dr. Doreen Granpeesheh, Executive Director).

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Authors and Affiliations

  1. Division of Neurodevelopmental and Behavioral Pediatrics, Department of Pediatrics, University of Rochester Medical Center, 265 Crittenden Blvd., Rochester, NY, 14620, USA

    Susan L. Hyman, Jennifer Foley, Usa Cain, Danielle D. Morris & Tristram Smith

  2. Department of Pediatrics and Clinical and Translational Sciences Institute, Saunders Research Building, University of Rochester Medical Center, 265 Crittenden Blvd., Rochester, NY, 14642, USA

    Patricia A. Stewart & Robin Peck

  3. Department of Biostatistics and Computational Biology, Saunders Research Building, University of Rochester Medical Center, 265 Crittenden Blvd., Rochester, NY, 14642, USA

    Hongyue Wang

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  1. Susan L. Hyman
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Correspondence to Susan L. Hyman.

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Hyman, S.L., Stewart, P.A., Foley, J. et al. The Gluten-Free/Casein-Free Diet: A Double-Blind Challenge Trial in Children with Autism. J Autism Dev Disord 46, 205–220 (2016). https://doi.org/10.1007/s10803-015-2564-9

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