Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02442115|
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : January 10, 2019
|Condition or disease||Intervention/treatment|
|Autistic Disorder Constipation Gastrointestinal Diseases||Other: Treatment of Functional Constipation by|
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:
- 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 :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||The MET Signaling System, Autism and Gastrointestinal Dysfunction|
|Actual Study Start Date :||September 2009|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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.
Other: Treatment of Functional Constipation by
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 Name: NASPGHAN standard of care
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.
- Reduction in F2-IsoProstanes (IsoPs) oxidative stress biomarker [ Time Frame: 1 year ]
- Reduction in T-score from Social Responsiveness Scale (SRS-2) (Teacher questionnaire) [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442115
|Contact: Pat Levitt, PhD||TummyTroubles@chla.usc.edu|
|Contact: Sandra Figueroa, BSemail@example.com|
|United States, California|
|Children's Hospital Los Angeles||Recruiting|
|Los Angeles, California, United States, 90027|
|Contact: Pat Levitt, PhD Tummytroubles@chla.usc.edu|
|Contact: Sandra Figueroa 323-361-5284 firstname.lastname@example.org|
|The Center for Autism & Neurodevelopmental Disorders||Recruiting|
|Santa Ana, California, United States, 92705|
|Contact: John Donnelly, MD|
|Contact: Jennifer Phan 949- 267-0454 email@example.com|
|Principal Investigator:||Pat Levitt, PhD||Children's Hospital Los Angeles|