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:
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
  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:
  • 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

  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 April 21, 2014