Autism Clinical Trial
Official title:
A Study to Assess the Role of a Gluten Free-Casein Free Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
Doctors at MassGeneral Hospital for Children (MGHfC) are doing a research study to learn if
a gluten free-dairy free (GFCF) diet is helpful in improving gastrointestinal symptoms
associated with autism.
Hypothesis: The gluten free/casein free diet (GFCF) will result in a higher proportion of
subjects having reduction in gastrointestinal (GI) symptoms associated with autism spectrum
disorders (ASD).
Primary Study Objective:
- To assess the effect of a GFCF diet on GI symptoms associated with ASD.
Secondary Objectives:
- To assess if improvements in GI symptoms result in improvements in autistic behavior
when using a GFCF diet in the dietary management of GI symptoms associated with ASD
- To determine the nutritional impact of a GFCF restrictive diet
- To assess the role of food allergies in the manifestation of GI symptoms
This is a 14-week study that requires between 5 & 9 office visits. All study related
activities -including physical exams, blood samples and allergy testing - and an amino acid
based supplement drink, are at no cost. Research study visits will take place at MGHfC in
Boston, or at Newton Wellesley Hospital in Newton, or at Lurie Center/LADDERS in Lexington.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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