A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders (GFCF)
|ClinicalTrials.gov Identifier: NCT01116388|
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : April 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Autism Gastrointestinal Symptoms||Other: GFCF product with GFCF diet Other: product containing gluten and casein (milk protein) with GFCF diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Study to Assess the Role of a Gluten Free-Casein Free Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|