Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE May 3, 2010
First Posted Date  ICMJE May 5, 2010
Last Update Posted Date April 8, 2015
Study Start Date  ICMJE April 2010
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2012)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01116388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
Official Title  ICMJE A Study to Assess the Role of a Gluten Free-Casein Free Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism
  • Gastrointestinal Symptoms
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 7, 2015)
65
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2010)
30
Actual Study Completion Date  ICMJE April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01116388
Other Study ID Numbers  ICMJE 2008-P-002385
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Harland S. Winter, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Nutricia North America
Investigators  ICMJE
Principal Investigator: Harland S Winter, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date April 2015

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