Status:
RECRUITING
Open-label Pilot Study Synbiotic Treatment for Autism Spectrum Disorder
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Autism Spectrum Disorder
Anxiety
Eligibility:
All Genders
2-12 years
Phase:
NA
Brief Summary
The objective of this study is to conduct a open-label pilot study evaluating the feasibility, tolerability and preliminary efficacy of a 12-week course of synbiotic in improving anxiety symptoms in c...
Detailed Description
Autism spectrum disorder (ASD) is a neurodevelopmental disorder defined by the core features of social communication deficits and restricted and repetitive behaviour (RRB). One important treatment tar...
Eligibility Criteria
Inclusion
- ASD children of Chinese ethnicity aged \<12 with diagnosis made by child psychiatrists based on Diagnostic and Statistical Manual, Fifth Edition (DSM-5) diagnostic criteria.
- Elevated anxiety level, as measured by Anxiety Scale for Children-Autism Spectrum Disorder (ASC-ASD)
- Presence of sensory hyperresponsiveness, as measured by Sensory Experience Questionnaire (SEQ)
Exclusion
- Co-occurring mental retardation, neurological, psychosis, depression or other severe mental illness.
- History of non-functional gastrointestinal disorders such as inflammatory bowel disease and Hirschsprung's disease.
- Presence of other significant physical illness, including but not limited to: current active malignancy, immunosuppression, organ failure and epilepsy
- Exposure to antibiotics within 1 months of the study or history of using probiotics.
- On special diet such as being a vegetarian
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06126185
Start Date
December 1 2023
End Date
July 31 2025
Last Update
February 7 2024
Active Locations (1)
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1
The Chinese University of Hong Kong
Hong Kong, Hong Kong