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A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders (GFCF)

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ClinicalTrials.gov Identifier: NCT01116388
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : April 8, 2015
Sponsor:
Collaborator:
Nutricia North America
Information provided by (Responsible Party):
Harland S. Winter, MD, Massachusetts General Hospital

Study Description
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Brief Summary:

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
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
Study Start Date : April 2010
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Casein

Arms and Interventions
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Arm Intervention/treatment
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:
  • test product
  • GFCF
  • gluten free- casein free diet
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:
  • control product
  • product containing gluten and casein
  • GFCF diet


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116388


Locations
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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
Sponsors and Collaborators
Massachusetts General Hospital
Nutricia North America
Investigators
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Principal Investigator: Harland S Winter, MD Massachusetts General Hospital
More Information
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Responsible Party: Harland S. Winter, MD, Director, Pediatric Inflammatory Bowel Disease Center, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01116388    
Other Study ID Numbers: 2008-P-002385
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015
Keywords provided by Harland S. Winter, MD, 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:
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Gastrointestinal Diseases
Digestive System Diseases
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
 Mental Disorders
Caseins
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action