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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524673-16-00

Enrollment

Registered

2026-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism spectrum disorder

Brief summary

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.

Detailed description

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

Interventions

DRUGSUSPENSION FOR FAECAL MICROBIOTA TRANSPLANTATION

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

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

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 18, 2026