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OpenTrials
Completed

NCT Number: NCT01675414

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

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.

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Key information

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

LADDERS, Massachusetts General Hospital

Boston, Massachusetts, 02412, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

evaluation visit by a pediatric gastroenterologist

Other

medical history, physical exam completed by pediatric gastroenterologist

Other names: autism, ASD, pediatric, gastrointestinal

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

    Time frame: 6 months after initial evaluation by pediatric gastroenterologist

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Autism Speaks
  • Columbia University

Registry information

Official study title

Understanding Gastrointestinal Conditions in Children With ASD

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Aug 30, 2012
Registry last updated
Aug 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.