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:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT06448767
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of ASD according to the Diagnostic and Statistical Manual of Mental Disorders, the fifth edition (DSM-5) or International Classification of Diseases, Tenth Revision (ICD-10).
2. Children either not taking any medication or receiving the same medication for the last 2 months.
3. Patients, or their parents/caregivers, are willing to provide written informed consent, proceed with nutritional supplements throughout the 3-month trial, refrain from starting any kind of special diet for the duration of the study, and complete the questionnaires at two time points during the study.
Exclusion Criteria:
1. Use of antibiotics in the previous 2 months before enrolling (excluding topical antibiotics).
2. Use of probiotics or synbiotics within the previous 2 months.
3. History of intolerance or allergy to probiotics, synbiotics or any other study product component.
4. Surgery with bowel resection or short bowel syndrome.
5. Children with severe immunodeficiency.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
15 Years
Study:
NCT06448767
Study Brief:
Protocol Section:
NCT06448767