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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

NCT01116388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2015-04-08

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Nutricia North America

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Harland S Winter, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01116388 on ClinicalTrials.gov