Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT06906068
Eligibility Criteria:
Inclusion Criteria:
* Being an autistic child with normal intelligence as documented by a neuropsychology assessment at the time of ASD diagnosis based on the ADOS score and the clinical impression of a multidisciplinary team of experts in autism diagnosis in the Department of Psychiatry;
* Being between the ages of 4 and 11 years;
* Acceptance and ability of the child to consume the probiotics product.
Exclusion Criteria:
* Epilepsy;
* Autism in the context of a genetic syndrome such as Fragile X or Bourneville sclerosis;
* Known presence of cancer, diabetes, celiac disease or inflammatory bowel disease (Crohn's disease or ulcerative colitis);
* Genetic disorder such as trisomy 21 or 14;
* Immune system disorder;
* Intolerance or allergy to Bio-K+ pea-based probiotics;
* Having taken antibiotics or probiotics in the previous 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
11 Years
Study:
NCT06906068
Study Brief:
Protocol Section:
NCT06906068