Skip to content

Clinical study of the effect of intravenous human immunoglobulin in the treatment of autistic children with high expression of serum inflammatory factors

Clinical study of the effect of intravenous human immunoglobulin in the treatment of autistic children with high expression of serum inflammatory factors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500111846
Enrollment
Unknown
Registered
2025-11-06
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Interventions

Experimental group:Intravenous Immunoglobulin

Sponsors

The First Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Conform to The Diagnostic criteria for ASD in the Diagnostic and Statistical Manual of Mental Disorders- Fifth Edition (DSM-V); 2. Age: 3 to 12 years old, gender not limited. 3. After ruling out active inflammation in other parts, the serum cytokine test shows that any one of the cytokines IL-1, IL-2, IL-6, IL-8, IL-10 or TNF-a is more than 1.5 times higher than the upper limit of normal. 4. No known immune deficiency diseases, and no major functional abnormalities in blood routine, liver, kidney, heart or lung. 5. Clinical research participants and/or guardians can fully understand the informed consent content of this study and voluntarily sign the informed consent form; 6. Improve the preoperative eight items of serum and humoral immunity tests, and rule out contraindications for hepatitis C.

Exclusion criteria

Exclusion criteria: 1. The patient has a history of tumors or tumors (including hematological tumors and solid tumors); 2. There is a history of severe allergic reactions and blood product allergies in the past; 3. Autism caused by clear single-gene diseases, chromosomal abnormalities, or abnormal brain development; 4. Accompanied by other mental disorders besides autism spectrum disorder; 5. Participated in other clinical studies or experimental treatments related to ASD in the past half year; 6. Situations where other researchers consider it inappropriate to be included in the group.

Design outcomes

Primary

MeasureTime frame
SRS score results;Results of ABC scores on the Vineland scale;

Secondary

MeasureTime frame
Incidence of adverse events during treatment;The changes in serum inflammatory factor levels after treatment;The changes in serum metabolomics indicators after treatment;

Countries

China

Contacts

Public ContactGuang Yang

The First Medical Center of PLA General Hospital

yangg301@126.com+86 138 1019 2267

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 21, 2026