Ignite Creation Date:
2024-05-06 @ 4:03 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02442115
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-11-15
First Post:
2015-03-25
Brief Title:
Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
Sponsor:
Childrens Hospital Los Angeles
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
The MET Signaling System Autism and Gastrointestinal Dysfunction
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 interestsrepetitive 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 Childrens Hospital Los Angeles CHLA and the Childrens Hospital at Vanderbilt University The current research project proposes to recruit subject at CHLA and the Center for Autism and Developmental Disorders CAND a Childrens 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 study Rather subjects will receive standard of care for the GID diagnosis and secondary effects on ASD symptoms will be evaluated Our power calculation shows that the investigators will be adequately powered with the proposed study design and recruitment targets As part of the study the investigators have developed a collaboration with investigators in the University of Southern California USC School of Engineering in which the investigators will work with them to develop computational tools to assist in the characterization of videotaped Autism Diagnostic Observation Schedule ADOS-2 assessments
Detailed Description:
Children ages 7 years 0 months to 12 years 11 months will be recruited into 1 clinical group ASDFC 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 IrvineOrange County-affiliated clinics
Center for Autism and Neurodevelopmental Disorders in Orange County
Childrens 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 refluxdyspepsia 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 instrumentsquestionnaires 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
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 IrvineOrange County-affiliated clinics
Center for Autism and Neurodevelopmental Disorders in Orange County
Childrens 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 refluxdyspepsia 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 instrumentsquestionnaires 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None