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CompletedNCT01675414Updated Aug 30, 2012

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

An observational study in Gastrointestinal Disorders and Autism Spectrum Disorders, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2012-08-30.

Sponsored by Massachusetts General Hospital · Observational

Study type
Observational
Model
Cohort
Enrollment
131
Ages
2 Years to 17 Years
Sex
All
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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.

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Conditions studied

  • Gastrointestinal Disorders
  • Autism Spectrum Disorders

Keywords

  • ASD
  • autism
  • gastrointestinal
  • gastrointestinal conditions in children with ASD
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In context

Gastrointestinal Diseases

628 studies on the registry are indexed under Gastrointestinal Diseases; 129 are open to participants now.

This study's enrollment of 131 is below the median of 325 across 190 observational studies indexed under Gastrointestinal Diseases.

Browse Gastrointestinal Diseases studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

131 nonselected subjects with ASD

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

Exclusion Criteria:

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

Observational model
Cohort
Enrollment
131 participants (actual)

Interventions

  • Otherevaluation visit by a pediatric gastroenterologist

    medical history, physical exam completed by pediatric gastroenterologist

    Also known as: autism, ASD, pediatric, gastrointestinal

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What researchers measure

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

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Study locations

1 site
  • LADDERS, Massachusetts General Hospital
    Boston, Massachusetts 02412, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01675414
Lead sponsor
Massachusetts General Hospital
Collaborators
Autism Speaks, Columbia University
Responsible party
Harland S. Winter, MD (Director, Pediatric Inflammatory Bowel Disease Center, Massachusetts General Hospital) — Principal investigator
First posted
Aug 30, 2012
Start date
Sep 2008
Primary completion
Jun 2010
Completion
Feb 2011
Last update
Aug 30, 2012

Study contacts

Harland S Winter, MD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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