Neurodevelopmental and Behavioral Pediatrics


Gluten-Free Casein-Free Diet

Individual data from a double-blind placebo-controlled challenge study.

Many families place their children with autism spectrum disorder (ASD) on specialized diets such as the gluten-free and casein-free (GFCF) diet. We conducted a double-blind placebo controlled challenge study to test the safety and efficacy of the GFCF diet in 14 children with ASD (12 boys), age 2.5-5.5 years. All children were receiving >10 hours/week of ABA therapy. Children were placed on the GFCF diet for >4 weeks and then received one dietary challenge per week for 12 weeks. Four challenge conditions were presented in random sequence in a single-case, multi-element experimental design: placebo, gluten only, casein only, and gluten + casein. Data for individual children were examined in two domains of a behavior observation measure, the Ritvo-Freeman Real Life Rating Scale: social interaction and communication. Visual inspection of these data revealed no consistent differences among conditions for any of the 14 children in either domain. Thus, no evidence for reliable behavior change was found. Because the study included a small sample based on stringent eligibility criteria, it remains possible that different results would be obtained in subgroups not represented.

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