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. (see Contacts and Locations)
Verified May 2013 by Massachusetts General Hospital
Sponsor:
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

May 3, 2010
May 7, 2013
April 2010
October 2014   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01116388 on ClinicalTrials.gov Archive Site
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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
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Autism
  • Gastrointestinal Symptoms
  • 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
  • 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
  • test product
    product free of gluten and casein
    Intervention: Other: GFCF product with GFCF diet
  • control product
    product containing gluten and milk protein
    Intervention: Other: product containing gluten and casein (milk protein) with GFCF diet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
2 Years to 17 Years
No
Contact: Katherine F Murray, BSN 617-724-2004 kmurray8@partners.org
Contact: Marie A Washek, RD 617-724-2004 mawashek@partners.org
United States
 
NCT01116388
2008-P-002385
No
Harland S. Winter, MD, Massachusetts General Hospital
Massachusetts General Hospital
Nutricia North America
Principal Investigator: Harland S Winter, MD Massachusetts General Hospital
Massachusetts General Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP