Autistic DisorderNCT02442115
Impact of Improving Gastrointestinal Symptoms on Autism Symptoms and Oxidative Stress
An observational study of Autistic Disorder and Constipation, run by Children's Hospital Los Angeles at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Autistic Disorder, Constipation, Gastrointestinal Diseases
- What is being tested?
- Treatment of Functional Constipation by
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Apr 2015to 6 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with Autism Spectrum Disorders with and without functional constipation
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Los Angeles
Los Angeles, California, 90027
The Center for Autism & Neurodevelopmental Disorders
Santa Ana, California, 92705
About this study
Official title: The MET Signaling System, Autism and Gastrointestinal Dysfunction
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 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.
Read the 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.
- Conditions
- Autistic Disorder, Constipation, Gastrointestinal Diseases
- Being tested
- Treatment of Functional Constipation by
- Keywords
- Autism, Autism Spectrum Disorder (ASD), Tummy Troubles, Constipation, GI Disorders, Gastrointestinal Disorders, Gastrointestinal, Oxidative Stress, Stomach problems, Behaviors, Autistic, ASD, MET gene, GID, Pediatric, Pediatric GI disorders, Children with Autism, functional constipation
- Medical subject headings
- Autistic Disorder, Constipation, Gastrointestinal Diseases, Autism Spectrum Disorder, Digestive System Diseases, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of Functional Constipation byOther
Also called NASPGHAN standard of care
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Treatment of Functional Constipation by | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Reduction in F2-IsoProstanes (IsoPs) oxidative stress biomarker
Measured: 1 year
Reduction in T-score from Social Responsiveness Scale (SRS-2) (Teacher questionnaire)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study start29 Apr 2015
- Primary completion14 Feb 2018
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pat Levitt, PhD, Children's Hospital Los Angeles
- Investigators
- Pat Levitt, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02442115
- Sponsor's protocol ID
- CCI-09-00212
- Status last verified
- Dec 2024
- First submitted
- 25 Mar 2015
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MET Signaling System, Autism and Gastrointestinal Dysfunction
- ClinicalTrials.gov ID
- NCT02442115
- Acronym / sponsor ID
- CCI-09-00212
- Conditions
- Autistic Disorder, Constipation, Gastrointestinal Diseases
- Keywords
- Autism, Autism Spectrum Disorder (ASD), Tummy Troubles, Constipation, GI Disorders, Gastrointestinal Disorders, Gastrointestinal, Oxidative Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 29 Apr 2015 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 13 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 (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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD with GID | – | Other: Treatment of Functional Constipation byChildren 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. |
| 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with Autism Spectrum Disorders with and without functional constipation
Key inclusion criteria (9 listed)
- English or Spanish-speaking of any ethnicity
- Boys or girls aged 5 years 0 months to 17 years 11 months
- Gestational age between 36 and 42 weeks
- Birth weight of at least 2500 grams
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment of Functional Constipation byAlso: NASPGHAN standard of careThe 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 | ASD with GID |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pat Levitt, PhD principal investigator
Children's Hospital Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Disorder and Constipation, run by Children's Hospital Los Angeles at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in F2-IsoProstanes (IsoPs) oxidative stress biomarker (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.