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

NCT01675414 | Completed

• 1 other identifier: Grant 2037
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Disorders; Autism Spectrum Disorders

Keywords

ASD; autism; gastrointestinal; gastrointestinal conditions in children with ASD

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

evaluation visit by a pediatric gastroenterologist OTHER

medical history, physical exam completed by pediatric gastroenterologist

Also known as: autism, ASD, pediatric, gastrointestinal

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

131 nonselected subjects with ASD

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Autism Speaks: collaborator
• Columbia University: collaborator

Study Sites (1)

LADDERS, Massachusetts General Hospital

Boston, Massachusetts, 02412, United States

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Digestive System Diseases; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Harland S Winter, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pediatric Inflammatory Bowel Disease Center

Study Record Dates

• First Submitted: April 19, 2012
• First Posted: August 30, 2012
• Study Start: September 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: February 1, 2011
• Last Updated: August 30, 2012

Record last verified: 2012-08

Locations

US (1)