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

NCT ID: NCT01116388

Last Updated: 2015-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2015-04-30

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.

Conditions

Autism; Gastrointestinal Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

test product

product free of gluten and casein

Group Type: OTHER

GFCF product with GFCF diet

Intervention Type: OTHER

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.

control product

product containing gluten and milk protein

Group Type: OTHER

product containing gluten and casein (milk protein) with GFCF diet

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

test product; GFCF; gluten free- casein free diet; control product; product containing gluten and casein; GFCF diet

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nutricia North America

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Harland S. Winter, MD

Director, Pediatric Inflammatory Bowel Disease Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Harland S Winter, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

2008-P-002385

Identifier Type: -

Identifier Source: org_study_id