Understanding Gastrointestinal Conditions in Children With Autism Spectrum Disorder (ASD)

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01675414

Collaborator

Autism Speaks (Other), Columbia University (Other)

131

Enrollment

Location

Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to help us learn if children with Autism Spectrum Disorder (ASD) have gastrointestinal (stomach and intestine) problems more frequently than children without ASD do. The investigators hope to learn if children with ASD and gastrointestinal (GI) disorders have certain Problem Behaviors (PB), such as self-injury and aggression, more than children with ASD but no GI disorders do. The investigators want to learn if the Gastrointestinal Symptoms Questionnaire (GIQ) can help us tell which children with ASD also have gastrointestinal disorders.

Hypothesis 1: Children with ASD exhibit high rates of symptomatic GI dysfunction that are not identified by current diagnostic evaluation.

Hypothesis 2: Painful or discomfort-causing gastrointestinal dysfunctions contribute to an elevated incidence or severity of PB in an identifiable subpopulation of PB-expressing children. The investigators anticipate that the proposed study will raise the standard of medical care for children with ASD by improving current methods of identifying GI dysfunction and determining whether there is a significant relationship between GI dysfunction and PB in this population.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Disorders Autism Spectrum Disorders	Other: evaluation visit by a pediatric gastroenterologist

Study Design

Study Type:

Observational

Actual Enrollment :

131 participants

Observational Model:

Cohort

Official Title:

Understanding Gastrointestinal Conditions in Children With ASD

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Jun 1, 2010

Actual Study Completion Date :

Feb 1, 2011

Outcome Measures

Primary Outcome Measures

diagnosis of active gastrointestinal disorder/dysfunction based on the medical history reviewed by and the physical examination performed by a pediatric gastroenterologist [6 months after initial evaluation by pediatric gastroenterologist]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Children who are ATN Registry subjects between 2 and 17 years old (inclusive)
Meet criteria for an ASD according to the diagnostic measures Autism Diagnostic Observation Schedule (ADOS) and DSM-IV Symptom Checklist, which were conducted at an established ATN center within the last 18 months