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

Autism Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116388
• Other study ID #: 2008-P-002385
• Status: Completed
• Phase: N/A
• First received: May 3, 2010
• Last updated: April 7, 2015
• Start date: April 2010
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder
• Digestive System Diseases
• Gastrointestinal Diseases
• Gastrointestinal Symptoms

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Baylor College of Medicine / Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Nutricia North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks	No