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NCT02442115 · ClinicalTrials.gov registry record
Impact of Improving Gastrointestinal Symptoms on Autism Symptoms and Oxidative Stress
A clinical trial, sponsored by Children's Hospital Los Angeles.
- Completed
- Registry status
- 100
- Enrollment target
NCT02442115: Completed study, sponsored by Children's Hospital Los Angeles.
NCT02442115 is a clinical trial that has completed, run by Children's Hospital Los Angeles. The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02442115 has completed, sponsored by Children's Hospital Los Angeles.
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
The clinical manifestation of autism spectrum disorder (ASD) is complex, with medical and mental health disruptions that occur with the three core behavioral criteria used for diagnosis (social behavior, communication, restricted interests/repetitive behavior). Co-occurring medical conditions, such as gastrointestinal dysfunction (GID), often are overlooked when designing research strategies to understand the mechanisms underlying the expression of ASD. This study was initially a collaboration between Children's Hospital Los Angeles (CHLA) and the Children's Hospital at Vanderbilt University. The current research project proposes to recruit subject at CHLA and the Center for Autism and Developmental Disorders (CAND), a Children's Hospital of Orange County and University of California Irvine (UCI) Health collaborative program. In Aim 1, the investigators will characterize GID in pediatric populations with ASD. Over a 12 month period, subjects will receive standard of care for their GID, typically functional constipation. The study population will be characterized with a standardized instrument for diagnosing functional GI disorders in children, the Questionnaire on Pediatric Gastrointestinal Symptoms, and with the clinical acumen of an experienced pediatric gastroenterologist. Nutritional information also will be collected to determine whether there are patterns of GIDs that correlate with dietary and nutritional status. The in-depth characterization and treatment of GIDs in children with ASD will provide a unique way of determining if ASD symptom and GID symptom improvement are related to each other. In Aim 2, the investigators will do in-depth assessment of each subjects functional status for social communication, emotional regulation, cognitive function, speech-language, sensory integration, and a biomarker of oxidative stress. The latter will be measured in urine samples over the course of one year. There are no direct interventions for autism symptoms in this st
Interventions
- OTHER Treatment of Functional Constipation by
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2015-04-29 |
| Est. Completion | 2019-02-06 |
What the finished NCT02442115 record still lists
NCT02442115 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Treatment of Functional Constipation by is the first listed.
NCT02442115 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02442115 about?
NCT02442115 is a clinical study titled "Impact of Improving Gastrointestinal Symptoms on Autism Symptoms and Oxidative Stress". The clinical manifestation of autism spectrum disorder (ASD) is complex, with medical and mental health disruptions that occur with the three core behavioral criteria used for diagnosis (social behavior, communication, restricted interests/repetitive behavior). Co-occurring medical conditions, such ...
What is the current status of trial NCT02442115?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2015-04-29. Estimated completion is 2019-02-06.
What interventions are being tested in trial NCT02442115?
The interventions under investigation include: Treatment of Functional Constipation by (OTHER).
Who is sponsoring clinical trial NCT02442115?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
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