ALLOGENEIC FAECAL MICROBIOTA for Autism spectrum disorder

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- Congenital GIT defect or primary GIT disease, incl. medically confirmed coeliac disease (gluten enteropathy)\n- Newly initiated or recently changed formal behavioural, cognitive or cognitive-behavioural therapy (less than 30 days before enrolment)\n- Early reaction to food in the patient’s medical history\n- Expected inability to undergo bowel preparation (e.g. child’s inability to use liquid medication declared by parent)\n- Contraindication for common sedative medication, or serious complications of sedation in the patient’s medical history\n- Use of systemic immunosuppressants at present or in the last 3 months, or present medically confirmed immunocompromised status\n- Use of antiplatelet drugs, anticoagulants, or systemic antibiotics at present or in the last 3 months\n- Use of probiotics, prebiotics, or postbiotics at present or in the last 3 months\n- 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)\n- Newly initiated or recently changed pharmacotherapy (less than 30 days before enrolment)"}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Defined as a change of ±2 calibrated severity scores (CSS) on the ADOS-2, Module 1 examination which quantifies core symptom intensity."}

Secondary endpoints

• {"endpoint_text":"- Adverse events of FMT","definition_or_measurement_approach":"Collection and reporting of adverse events related to FMT (no further definition provided)."}
• {"endpoint_text":"- Bristol stool scale score, ATN-GISSI-17 questionnaire score","definition_or_measurement_approach":"Measured using the Bristol Stool Scale and the ATN-GISSI-17 questionnaire scores."}
• {"endpoint_text":"- PEDS-QL questionnaire score","definition_or_measurement_approach":"Measured using the PEDS-QL questionnaire score."}
• {"endpoint_text":"- Scores in CARS2, SEQ and SDQ questionnaires","definition_or_measurement_approach":"Measured using CARS2, SEQ and SDQ questionnaire scores."}

Czechia

Earliest CTIS Part Ii Submission Date

25-02-2026

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

20

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Masarykova Univerzita

Organisation Type

Educational Institution

Country Of Registered Address

Czechia

Third parties

• {"country":"Czechia","full_name":"Agency for Health Research of the Czech Republic (Ministry of Health of the Czech Republic)","duties_or_roles":"Source of monetary support / funder","organisation_type":""}
• {"country":"Czechia","full_name":"Masaryk University","duties_or_roles":"Source of monetary support / funder","organisation_type":""}