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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: Completed study of Autism Spectrum Disorders and Gastrointestinal Disorders, sponsored by Massachusetts General Hospital.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • OTHER evaluation visit by a pediatric gastroenterologist

Study Locations (1)

Massachusetts

  • LADDERS, Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 131 participants
Start Date 2008-09
Est. Completion 2011-02
Massachusetts General Hospital

2,032 total trials

What the finished NCT01675414 record still lists

NCT01675414 is an observational study that tracks outcomes without assigning an intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 162-participant average among 20 other Autism Spectrum Disorders trials with a reported enrollment target (19% lower).

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 a single indexed study location in 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.

Similar trials for Autism Spectrum Disorders

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01675414's enrollment target sits among peer trials

131 6th of 20 higher than 15 of 20 other Autism Spectrum Disorders trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Autism Spectrum Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01675414, the US trial registry maintained by the National Library of Medicine. NCT01675414 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.