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NCT01675414 · ClinicalTrials.gov registry record
Understanding Gastrointestinal Conditions in Children With Autism Spectrum Disorder (ASD)
A clinical trial of Autism Spectrum Disorders and Gastrointestinal Disorders, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 131
- Enrollment target
- 1
- Study location
NCT01675414 is a study of Autism Spectrum Disorders and Gastrointestinal Disorders that has completed, run by Massachusetts General Hospital. The registered enrollment target is 131 participants, below the 162-participant average among 20 other Autism Spectrum Disorders trials with a reported enrollment target (19% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01675414, a study of Autism Spectrum Disorders and Gastrointestinal Disorders, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 131 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- OTHER evaluation visit by a pediatric gastroenterologist
Study Locations (1)
Massachusetts
- LADDERS, Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2008-09 |
| Est. Completion | 2011-02 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01675414
The ClinicalTrials.gov registry entry for NCT01675414 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 162-participant average among 20 other Autism Spectrum Disorders trials with a reported enrollment target (19% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Autism Spectrum Disorders appearing as the primary indexed condition, and to 1 intervention - of which evaluation visit by a pediatric gastroenterologist is the first listed.
NCT01675414 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT01675414 about?
NCT01675414 is a clinical study titled "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 ce...
What is the current status of trial NCT01675414?
This trial is currently completed. The enrollment target is 131 participants. The study started on 2008-09. Estimated completion is 2011-02.
What conditions does trial NCT01675414 study?
This clinical trial studies the following conditions: Autism Spectrum Disorders, Gastrointestinal Disorders.
What interventions are being tested in trial NCT01675414?
The interventions under investigation include: evaluation visit by a pediatric gastroenterologist (OTHER).
Who is sponsoring clinical trial NCT01675414?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01675414 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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