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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)

Primary Purpose

Autism, Gastrointestinal Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GFCF product with GFCF diet
product containing gluten and casein (milk protein) with GFCF diet
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Autism, Gastrointestinal Disorders, Food Allergy, Gluten free, casein free diet, Diarrhea, Constipation, Reflux, Abdominal pain, Pain after eating, Self injurious behavior

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Baylor College of Medicine / Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

test product

control product

Arm Description

product free of gluten and casein

product containing gluten and milk protein

Outcomes

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
The effect of a GFCF diet on the dietary management of GI symptoms associated with autism is the primary outcome measure in the study.

Secondary Outcome Measures

Full Information

First Posted
May 3, 2010
Last Updated
April 7, 2015
Sponsor
Massachusetts General Hospital
Collaborators
Nutricia North America
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1. Study Identification

Unique Protocol Identification Number
NCT01116388
Brief Title
A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
Acronym
GFCF
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Nutricia North America

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism, Gastrointestinal Symptoms
Keywords
Autism, Gastrointestinal Disorders, Food Allergy, Gluten free, casein free diet, Diarrhea, Constipation, Reflux, Abdominal pain, Pain after eating, Self injurious behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
test product
Arm Type
Other
Arm Description
product free of gluten and casein
Arm Title
control product
Arm Type
Other
Arm Description
product containing gluten and milk protein
Intervention Type
Other
Intervention Name(s)
GFCF product with GFCF diet
Other Intervention Name(s)
test product, GFCF, gluten free- casein free diet
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
product containing gluten and casein (milk protein) with GFCF diet
Other Intervention Name(s)
control product, product containing gluten and casein, GFCF diet
Intervention Description
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
Primary Outcome Measure Information:
Title
A study to assess the role of a gluten free-casein free diet in the dietary management of autism associated gastrointestinal disorders
Description
The effect of a GFCF diet on the dietary management of GI symptoms associated with autism is the primary outcome measure in the study.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harland S Winter, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Baylor College of Medicine / Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States

12. IPD Sharing Statement

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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

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