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

Prior treatment

• Newly initiated or recently changed formal behavioural, cognitive or cognitive-behavioural therapy (less than 30 days before enrolment)
• Expected inability to undergo bowel preparation (e.g. child’s inability to use liquid medication declared by parent)
• Contraindication for common sedative medication, or serious complications of sedation in the patient’s medical history
• Use of antiplatelet drugs, anticoagulants, or systemic antibiotics at present or in the last 3 months
• Newly initiated or recently changed pharmacotherapy (less than 30 days before enrolment)

Other illness

• Congenital GIT defect or primary GIT disease, incl. medically confirmed coeliac disease (gluten enteropathy)
• Severe co-morbid conditions (e.g. psychosis, epilepsy uncontrolled by medication, presence of severe visual or hearing impairment) that may interact with study procedures (at discretion of the investigator)

Other

• Early reaction to food in the patient’s medical history
• Use of systemic immunosuppressants at present or in the last 3 months, or present medically confirmed immunocompromised status
• Use of probiotics, prebiotics, or postbiotics at present or in the last 3 months

• Age 3–12 years
• Diagnosis of ASD confirmed by a clinical psychologist or psychiatrist
• Previous ADOS-2 examination result in the ASD range
• Only minimum verbal ability (i.e. corresponding to ADOS-2, Module 1)
• Informed consent of the parent (legal representative) and willingness to follow all planned study visits and instructions, especially for bowel preparation