Clareo Health | A Study to Assess the Role of a Gluten Free-dairy Free (GFCF) Diet in the Dietary Management of Autism Associated Gastrointestinal Disorders
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Massachusetts General Hospital
With
Nutricia North America
Age
2–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
