Effect of faecal microbiota transplant on the expression of autism spectrum disorder core symptoms in children – open-label phase II clinical trial (FMT-PAS)
Key facts
- Where
- Brno, CsehországSee the site
- Phase
- 2. fázis
Where in Csehország
- Fakultni nemocnice BrnoBrno, CsehországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Masarykova Univerzita
- Trial code
- EU 2025-524673-16-00
- Record updated
- 2026. március 17.
- Original description
The primary objective of the trial is to describe the effect of faecal microbiota transplant (FMT) on autism spectrum disorder core symptoms.Read full original descriptionShow less
The primary objective of the trial is to describe the effect of faecal microbiota transplant (FMT) on autism spectrum disorder core symptoms.
Inclusion: 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.
Exclusion: 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); 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); 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.