ASC - Autism Study
Autism Spectrum Disorder, Gastrointestinal Dysfunction, Leaky Gut Syndrome
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Gastrointestinal microbiota, Gut-brain axis, Immunomodulation
Eligibility Criteria
Inclusion Criteria: Diagnosis of autism spectrum disorder. Ongoing gastrointestinal symptoms or previous gastrointestinal symptoms which disappeared or were reduced after dietary changes. Age 6 to 14 years. Exclusion Criteria: Known genetic syndrome or pathogenic mutation or copy number variation associated with autism spectrum disorder. Known CNS-infection (now or previously) and/or HIV positivity. Primary immunodeficiency disorder or autoimmune cytopenia. Current treatment with cytotoxic drugs or systemic administered glucocorticoids and/or immunosuppressive therapy or other antiinflammatory medication (except nonsteroidal anti-inflammatory drugs). Epilepsy or known seizure disorder (now or previously).
Sites / Locations
- Department of Child and Adolescent Psychiatry, Psychiatry Clinic South, Aalborg University Hospital, DenmarkRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
1 x 1000000 C2C_ASCs/kg body weight
2 x 1000000 C2C_ASCs/kg body weight
Trial participant 1 - 5 will be treated with 1 x 1000000 C2C_ASCs/kg body weight
Trial participant 6 - 10 will be treated with 2 x 1000000 C2C_ASCs/kg body weight