- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02442115
Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
The MET Signaling System, Autism and Gastrointestinal Dysfunction
Study Overview
Status
Intervention / Treatment
Detailed Description
Children ages 7 years 0 months to 12 years 11 months will be recruited into 1 clinical group (ASD+/FC+), utilizing the following clinics in Southern California:
CHLA-affiliated Clinics
- Boone-Fetter Clinic, home of the CHLA Autism Treatment Network
- University Center of Excellence on Developmental Disabilities (UCEDD) Clinic at CHLA - UC Irvine/Orange County-affiliated clinics
- Center for Autism and Neurodevelopmental Disorders in Orange County
- Children's Hospital of Orange County Exclusion criteria include a diagnosed syndromic disorder, prematurity, failure to meet standard birth weight, not enrolled in any ASD treatment program. For each child, the Questionnaire on Pediatric Gastrointestinal Symptoms (QPGS)-Rome III is administered and the child is seen by a board-certified pediatric gastroenterologist. The child will be seen at baseline, 3, 6 and 12 months for their research visits. Treatment of FC in children with ASD is based on the Autism Treatment Network (ATN) modified protocol of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) and includes the following: 1) a thorough dietary history is reviewed and adjusted for introducing a diet rich in fiber (or supplements if able to be tolerated by the child; typically this will be in older children in the study); 2) assessment of abdominal pain, perianal skin tags, hemorrhoids, fissures, rectal exam if needed, frequency of stooling, quality of stool, rectal bleeding, other possible associated symptoms such as reflux/dyspepsia, vomiting, headaches, increase or decrease in appetite; 3) behavioral techniques, such as toileting after meal times, and other strategies are added; and 4) medicine and dietary adjustments are made. At each visit, the following instruments/questionnaires will be administered by a clinical psychologist: 1) social responsiveness scale; 2) Kaufman Brief Intelligence Test; 3) Child Behavior Checklist; 4) Aberrant Behavior Checklist; 5) Pediatric Quality of Life Inventory (Peds QL); 6) Repetitive Behavioral Scale-Revised; 7) Autism Impact Measure; 8) Pearson Short Sensory Profile. The Vineland will be administered at baseline and 12 months. The ADOS-2 will be used at baseline to ensure an ASD diagnosis.
At each visit, subject urine is collected and stored until an assay for the oxidative stress marker F2-isoprostane is measured.
A buccal swab is collected and DNA extracted for future genetic studies.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90027
- Children's Hospital Los Angeles
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Santa Ana, California, United States, 92705
- The Center for Autism & Neurodevelopmental Disorders
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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:
- English or Spanish-speaking of any ethnicity
Boys or girls aged 5 years 0 months to 17 years 11 months
- A clinical diagnosis of functional constipation (FC) for the ASD+/FC+ group, with or without encopresis
- Clinical assessment of ASD using Diagnostic and Statistical Manual of Mental Disorders (DSM IV or V criteria)
- ADOS-validated diagnosis of ASD
- Gestational age between 36 and 42 weeks
Birth weight of at least 2500 grams
Children with suspected or an existing clinical diagnosis of ASD and FC will be recruited and consented for the study. Assessments and clinical diagnosis may be completed and confirmed through the Baseline study visit for subjects to be eligible.
- Teacher participation is not required for child participation. However, teacher participation will be requested around the time of child enrollment.
Exclusion Criteria:
- severe sensory or motor impairments (deafness, blindness;
- identified inherited metabolic, syndromic, or progressive neurological disorders (including epilepsy, Down Syndrome, Rett Syndrome, Tuberous Sclerosis, Neurofibromatosis, Fragile X Syndrome);
- a non-functional GID, such as ulcerative colitis, Celiac disease or Hirschsprung's disease;
- failure to meet birth weight/gestational age as noted above
- participation in another ASD research study at the same time
- not enrolled in an ASD intervention program
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ASD with GID
Children with Autism Spectrum Disorder with Functional Constipation will be treated with standard of care defined by NASPGHAN by a pediatric gastroenterologist, and evaluated at 4 visits over 1 year for their medical condition.
These children will be enrolled in some ASD treatment program by their parents.
The treatment program is not part of the current study.
Measures of ASD symptoms will be done at each visit to determine social communication, emotional and cognitive improvement due to the FC treatment.
Measures of F2-isoprostane, a marker of oxidative stress, will be done at each visit to determine if FC treatment and ASD symptom improvement relates to improvement in a child's physiology.
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The NASPGHAN protocol is used by pediatric gastroenterologist to treat functional constipation.
Status is monitored at 4 visits and adjustments to treatment are made based on clinical standards and judgment.
Other Names:
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ASD without GID
Children Autism Spectrum Disorder without Functional Constipation will be evaluated for their ASD symptoms at 4 times over 1 year.
These children will be enrolled in some ASD treatment program by their parents.
The treatment program is not part of the current study.
Measures of F2-isoprostane, a marker of oxidative stress, will be done at each visit to determine if ASD symptom improvement relates to improvement in a child's physiology.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in F2-IsoProstanes (IsoPs) oxidative stress biomarker
Time Frame: 1 year
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1 year
|
Reduction in T-score from Social Responsiveness Scale (SRS-2) (Teacher questionnaire)
Time Frame: 1 year
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1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pat Levitt, PhD, Children's Hospital Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-00212
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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