Clinical trial NCT01116388: A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Nutricia North America
First posted: 2010-05-05
Enrollment: 65
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: A study to assess the role of a gluten free-casein free diet in the dietary management of autism associated gastrointestinal disorders
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Houston
country: United States
facility: Baylor College of Medicine / Texas Children's Hospital
state: Texas
Study officials:
affiliation: Massachusetts General Hospital
name: Harland S Winter, MD
role: PRINCIPAL_INVESTIGATOR
References: