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

Autism Spectrum Disorders Clinical Trial

Official title:

Understanding Gastrointestinal Conditions in Children With ASD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675414
• Other study ID #: Grant 2037
• Status: Completed
• Phase: N/A
• First received: April 19, 2012
• Last updated: August 29, 2012
• Start date: September 2008
• Est. completion date: February 2011

Study information

• Verified date: August 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: February 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Exclusion Criteria:

• Diagnoses of Rett Syndrome, Childhood Disintegrative Disorder, or other genetic disorders (e.g. Fragile X, Down syndrome, etc.).

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Autism Spectrum Disorders
• Child Development Disorders, Pervasive
• Digestive System Diseases
• Disease
• Gastrointestinal Diseases
• Gastrointestinal Disorders

Intervention

Other:
• evaluation visit by a pediatric gastroenterologist
medical history, physical exam completed by pediatric gastroenterologist

Locations

Country	Name	City	State
United States	LADDERS, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Autism Speaks, Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No