A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Psychiatric, Gastrointestinal, Autism, Digestive Disease |
| Therapuetic Areas: | Gastroenterology, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 2 - 17 |
| Updated: | 3/16/2015 |
| Start Date: | April 2010 |
| End Date: | October 2014 |
| Contact: | Katherine F Murray, BSN |
| Email: | kmurray8@partners.org |
| Phone: | 617-724-2004 |
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.
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.
Inclusion Criteria:
- Informed consent / Assent, as applicable must be signed prior to executing any study
related procedure
- Children, male or female, 2 to 17 years old (inclusive)
- Confirmed diagnosis of ASD according to the diagnostic measures:
- DSM-IV Symptom Checklist
- Autism Diagnostic Observation Schedule(ADOS)&/or Autism Diagnostic Interview
Revised(ADI-R)within 18 months prior to entry into the study
- Subjects must present with a current history of at least two of the following
persistent GI symptoms as confirmed by the study physician:
- Diarrhea, as characterised by three or more loose stools a day for at least 8
out of 14 days
- Constipation as characterised by less than 3 bowel movements per week, for at
least a 2-week period
- Esophageal reflux, as characterised by 3 or more episodes of regurgitation per
day on 10 out of 14 days
- Abdominal pain manifested as pain after eating or self injurious behavior on at
least 8 out of 14 days
- Suspected food allergy which is confirmed by a physician, as characterized as a
recurrent reaction or association with specific foods
- Subject able to consume 3 tablespoons of study powder mixed in food daily for 12
weeks
Exclusion Criteria:
- Children with a history of anaphylaxis to dietary milk and wheat proteins
- Children with severe concurrent illness
- Children who are prescribed systemic steroids
- Children currently receiving chelation therapy, hyperbaric or antifungal treatment
within 1 month of entry into the study and during the study period.
- Children with a confirmed diagnosis of celiac disease
- Subjects who have previously tried dietary elimination of casein and gluten for at
least 1 month period and failed to demonstrate a response by parent perception
- Children who are unable to consume 3 tablespoons of study powder mixed in food daily
for 12 weeks daily
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