Blood tests to identify biomarkers in children with autism
Proteomic Biomarker Tests in Blood Samples from Children with Autism Spectrum Disorder (ASD)
This study is testing whether blood, stool, and urine samples can help find signs of immune issues in children with autism to improve early diagnosis and understanding of the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 900 (estimated) |
| Ages | 10 Months to 19 Years |
| Sex | All |
| Sponsor | Cell El Ltd Industry-sponsored |
| Locations | 1 site (Jerusalem) |
| Trial ID | NCT02168868 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify immune abnormalities in children diagnosed with Autism Spectrum Disorder (ASD) by analyzing blood, stool, and urine samples. It will involve various cohorts, including young children with ASD, typically developing children, and high-risk infants with a family history of ASD. Parents will complete questionnaires about their child's development, and samples will be collected at different stages, including before any stem cell transplantation therapy. The goal is to develop objective diagnostic tests that could facilitate early intervention and improve understanding of ASD pathogenesis.
Who should consider this trial
Good fit: Ideal candidates include children aged 2-18 years diagnosed with ASD, high-risk infants with a sibling diagnosed with ASD, and typically developing children aged 2-12 years.
Not a fit: Patients who have recently undergone treatment with systemic steroids or immune suppressants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more objective diagnoses of autism, allowing for timely interventions.
How similar studies have performed: While there is ongoing research into biomarkers for ASD, this specific approach focusing on immune abnormalities is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male and female children 2. Child aged 2-12 years with diagnosed ASD according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV (299.00) or DSM-V (299.00) OR Child aged 2-18 years diagnosed ASD according to DSM-IV (299.00) or DSM-V (299.00) AND scheduled to undergo stem cell transplantation OR Child aged 10-19 months not diagnosed with ASD but with a sibling diagnosed with ASD according to (DSM)-IV (299.00) or DSM-V (299.00) (herein termed "high-risk infants") OR Mothers of recruited high-risk infants OR A typically developing child aged 2-12 years with no signs of ASD or history of ASD in the immediate family 3. Informed consent signed by the parent/legal guardian Exclusion Criteria: 1. Child and/or mother completed treatment with systemic steroids or immune suppressants less than 4 weeks before the screening visit 2. Child and/or mother diagnosed with severe infectious diseases or sepsis over the last 6 months 3. Child with ASD treated for a severe convulsive disorder (intractable seizures) 4. Child and/or mother with hematological or malignant disorder 5. For children in the SCT cohort: No new planned immune-modulating treatment (other than SCT) for at least 6 months before or after planned stem cell transplantation date 6. If the PI suspects that the participant will not comply with study requirements, the participant may be excluded.
Where this trial is running
Jerusalem
- Shaare Zedek Medical Center — Jerusalem, Israel (Recruiting)
Study contacts
- Principal investigator: Benjamin Gesundheit, MD — Cell El Ltd
- Study coordinator: Benjamin Gesundheit, M.D.
- Email: gesundheitmd@cell-el.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.