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 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT06352203
Eligibility Criteria:
Inclusion Criteria:
* Children aged 3 to 7 years old.
* Diagnosed with autism spectrum disorder, according to the clinical criteria of the "Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)" and who meet criteria for ASD according to the ADOS-2 classification.
* Presenting one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, flatulence).
* Written informed consent signed by the parent or legal guardian with express or tacit consent of the other parent.
Exclusion Criteria:
* With intake of antibiotics in the last month.
* With intake of probiotics in the last two weeks.
* Diagnosed with short bowel syndrome or has undergone relevant surgery on the gastrointestinal tract.
* Exhibiting a defect in the intestinal epithelial barrier (e.g. inflammatory bowel disease (IBD)).
* Diagnosed with endocrinological diseases such as diabetes mellitus, hypo- and hyperthyroidism, Cushing's disease, Addison's disease, etc.
* Having heart failure and a cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).
* Congenital or acquired immunodeficiency.
* Immunocompromised (e.g., cancer and/or transplant patients taking certain immunosuppressive drugs, patients with inherited diseases that affect or may affect the immune system).
* Uncertainty on the part of the investigator about the willingness or ability of the minor's parents or legal guardian to comply with the requirements of the protocol.
* With oral hyper sensitivity impairments that prevent the uptake of the study product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
7 Years
Study:
NCT06352203
Study Brief:
Protocol Section:
NCT06352203