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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 May 2013
• Main ID: NCT01116388
• Date of registration: 03/05/2010
• Primary sponsor: Massachusetts General Hospital
• Public title: A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders GFCF
• Scientific title: A Study to Assess the Role of a Gluten Free-Casein Free Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
• Date of first enrolment: April 2010
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01116388
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Katherine F Murray, BSN

• Name: Harland S Winter, MD
• Affiliation: Massachusetts General Hospital

Key inclusion & exclusion 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



Age minimum: 2 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Autism

Gastrointestinal Symptoms

Intervention(s)

Other: GFCF product with GFCF diet

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

Primary Outcome(s)

A study to assess the role of a gluten free-casein free diet in the dietary management of autism associated gastrointestinal disorders [Time Frame: 12 weeks]

Secondary ID(s)

2008-P-002385

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Nutricia North America