Effect of faecal microbiota transplant on the expression of autism spectrum disorder core symptoms in children – open-label phase II clinical trial (FMT-PAS)

Condition studied

Autism spectrum disorder

Investigational medicinal product(s)

Eligibility

Primary endpoint

The treatment response (improvement/worsening) will be defined as ± 2 calibrated severity scores (CSS) in ADOS-2, Module 1 examination, which quantifies core symptoms intensity.

Endpoint detail

Adverse events of FMT, Bristol stool scale score, ATN-GISSI-17 questionnaire score, PEDS-QL questionnaire score, Scores in CARS2, SEQ and SDQ questionnaires