Blood tests to identify biomarkers in children with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.