A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
This study is currently recruiting participants.
Verified May 2013 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
Collaborator:
Nutricia North America
Information provided by (Responsible Party):
Harland S. Winter, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01116388
First received: May 3, 2010
Last updated: May 7, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Autism Gastrointestinal Symptoms |
Other: GFCF product with GFCF diet Other: product containing gluten and casein (milk protein) with GFCF diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]The effect of a GFCF diet on the dietary management of GI symptoms associated with autism is the primary outcome measure in the study.
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
test product
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. Other Names:
|
|
control product
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 Other Names:
|
Eligibility| Ages Eligible for Study: | 2 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116388
Contacts
| Contact: Katherine F Murray, BSN | 617-724-2004 | kmurray8@partners.org |
| Contact: Marie A Washek, RD | 617-724-2004 | mawashek@partners.org |
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Sub-Investigator: Timothy M Buie, MD | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Sub-Investigator: Timothy M Buie, MD | |
| Sub-Investigator: Aeri Moon, M.D. | |
Sponsors and Collaborators
Massachusetts General Hospital
Nutricia North America
Investigators
| Principal Investigator: | Harland S Winter, MD | Massachusetts General Hospital |
More Information
No publications provided
| Responsible Party: | Harland S. Winter, MD, Director, Pediatric Inflammatory Bowel Disease Center, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT01116388 History of Changes |
| Other Study ID Numbers: | 2008-P-002385 |
| Study First Received: | May 3, 2010 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Massachusetts General Hospital:
|
Autism Gastrointestinal Disorders Food Allergy Gluten free, casein free diet Diarrhea |
Constipation Reflux Abdominal pain Pain after eating Self injurious behavior |
Additional relevant MeSH terms:
|
Autistic Disorder Digestive System Diseases Gastrointestinal Diseases Signs and Symptoms, Digestive Child Development Disorders, Pervasive Mental Disorders Diagnosed in Childhood |
Mental Disorders Signs and Symptoms Caseins Chelating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013