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The Gluten Free and Casein Free (GFCF) Diet: A Double Blind, Placebo Controlled Challenge Study

Posted May 19 2010 2:27pm

This study has been a long time coming. I’ve been hearing about it for years: a study on the GFCF diet for autistics. The study, led by Dr. Susan Hyman of the University of Rochester , has been on since August 2004.

The concept was fairly simple: get children on a GFCF diet. Monitor their diet for proper nutrition. Once the child is on the diet, give the child small snacks, some with small amounts of gluten or casien or both and some without. Track behaviors. The parents and children and most of the researchers were “blind” to which snacks had the gluten and or casien.

The results, as Kev has already blogged , are finally in. The result: autistic children, in general, are not affected by gluten or casien. The “autism is just a leaky gut” theory was never very well supported.

Does this mean that no autistic children have sensitivities to gluten or casien? Hardly. Being autistic is not a shield against food sensitivities. What this does tell us is that autism is not caused by these nutrients.

The abstract is up on the IMFAR website:

S. Hyman , Strong Center for Developmental Disabilities, Pediatrics, University of Rochester, Rochester, NY
P. A. Stewart , General Clinical Research Center, University of Rochester, Rochester, NY
T. Smith , Strong Center for Developmental Disabilities, University of Rochester, Rochester, NY
J. Foley , Pediatrics, University of Rochester, Rochester, NY
U. Cain , General Clinical Research Center, University of Rochester, Rochester, NY
R. Peck , General Clinical Research Center, University of Rochester, Rochester, NY
D. D. Morris , Pediatrics, University of Rochester, Rochester, NY
H. Wang , Biostatistics and Computational Biology, University of Rochester, Rochester, NY
Background: Approximately 1/3 of children with ASD receive dietary interventions. While families report dramatic clinical effects, two prior trials do not confirm these positive outcomes. Neither examined nutritional sufficiency or controlled for other interventions. This study was undertaken to examine the behavioral and physiologic effects of the GFCF diet and assess its nutritional adequacy.
Objectives: To evaluate the nutritional adequacy, physiological effects, and efficacy of the GFCF diet on symptoms of ASD using randomized double blind placebo controlled challenges in preschool children with ASD. Methods: ADI-R/ADOS positive children ages 30-54 months receiving at least 10 hours/week of early intensive behavioral intervention (EIBI) were recruited. They were screened for milk/wheat allergies, celiac disease, and anemia/iron status by RAST, TTG and CBC/ferritin respectively. After a strict GFCF diet for at least 4 weeks, they received weekly, grouped, randomized double blind challenges containing either 20 g wheat flour, 20 g evaporated milk, both, or neither on three separate occasions over 12 weeks . The challenges appeared identical and were similar in taste and texture. Laboratory monitoring and BMI recording occurred at baseline, 6,18,and 30 weeks. Behavioral data was collected at these times plus the day before then 2 and 24 hours after each challenge, Measures included: Bristol Stool Scale, Sleep Diaries, Actigraphy, Conners Abbreviated Rating Scale, and Target Symptoms Scale. Ritvo Freeman Real Life Rating Scales (RFRLRS) were recorded at 2 and 24 hours post challenge. Challenges occurred only if measures were at baseline levels. Data were analyzed by group and for individual children comparing baseline with 4 weeks on diet and then pre/post challenges.
Results: Twenty one children were recruited. Two were excluded for positive TTG, one for anemia. Four additional children were unable to establish the diet or left EIBI. Group data on the 14 successful participants (43.5 months, range 35-54 ; 12 males) demonstrated no statistical change in frequency or quality of stools, sleep, actigraphy for activity, or parent/teacher/observer scores of attention/activity for baseline/ diet or in pre/post challenge ratings. The group RFRLRS data 2 hours post challenge were higher after placebo than after challenges of casein (p=.013), gluten (p=0.024) or gluten + casein (p= 0.021). These differences were not present 24 hours post challenge. Single case analysis will be presented. All children were maintained within acceptable ranges for micro/macronutrients with intense weekly dietary monitoring.
Conclusions: This is the first study to examine the behavioral effects of a nutritionally monitored GFCF diet on attention, sleep, stool pattern, and core symptoms of ASD. While no favorable effects of the GFCF diet on attention, sleep and stool patterns were identified in group analyses, such effects may occur for individuals or for subgroups of children (e.g. with significant GI disease), providing the basis for positive anecdotal reports. Future studies need to address the potential effects of nutrition on behavior in children with ASD and be powered to evaluate subtle changes in core symptoms.
Funded by STAART NIMH PO1HD35466 and National Center for Research Resources (NCRR) NIH UL1RR024160; Autism Treatment Network/Autism Speaks – AIRP Network(HRSA)

The study has been picked up by a number of news outlets, including the LA Times , USA Today and ABC News .

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