- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01675414
Understanding Gastrointestinal Conditions in Children With Autism Spectrum Disorder (ASD)
Understanding Gastrointestinal Conditions in Children With 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02412
- LADDERS, Massachusetts General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months after initial evaluation by pediatric gastroenterologist
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harland S Winter, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Grant 2037
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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