A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders (GFCF)
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.
- 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.
|Autism Gastrointestinal Symptoms||Other: GFCF product with GFCF diet Other: product containing gluten and casein (milk protein) with GFCF diet|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||A Study to Assess the Role of a Gluten Free-Casein Free Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders|
- A study to assess the role of a gluten free-casein free diet in the dietary management of autism associated gastrointestinal disorders [ Time Frame: 12 weeks ]The effect of a GFCF diet on the dietary management of GI symptoms associated with autism is the primary outcome measure in the study.
|Study Start Date:||April 2010|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
product free of gluten and casein
Other: GFCF product with GFCF diet
Group I: will receive the test product (product free of gluten and casein) with GFCF Diet for the 1st 6-weeks.
Group II: will receive the test product (product free of gluten and casein) with GFCF diet for the 2nd 6-weeks.
product containing gluten and milk protein
Other: product containing gluten and casein (milk protein) with GFCF diet
Group I: will receive the control product (product containing gluten and casein) with the GFCF diet for the 2nd 6-weeks.
Group II: will receive the control product (product containing gluten and casein) with the GFCF diet for the 1st 6-weeks
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116388
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Texas|
|Baylor College of Medicine / Texas Children's Hospital|
|Houston, Texas, United States, 77054|
|Principal Investigator:||Harland S Winter, MD||Massachusetts General Hospital|