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

April 7, 2015 updated by: Harland S. Winter, MD, Massachusetts General Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Texas
      • Houston, Texas, United States, 77054
        • Baylor College of Medicine / Texas Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Nutricia North America

Investigators

  • Principal Investigator: Harland S Winter, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-P-002385

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autism

Clinical Trials on GFCF product with GFCF diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe