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Open-label Pilot Study Synbiotic Treatment for Autism Spectrum Disorder
RECRUITINGN/ASponsored by Chinese University of Hong Kong
Actively Recruiting
PhaseN/A
SponsorChinese University of Hong Kong
Started2023-12-01
Est. completion2024-12-31
Eligibility
Age2 Years – 12 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06126185
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 children with ASD. The investigators hypothesise that the course of synbiotic will feasible and tolerable, and that there will be a reduction in anxiety symptoms in ASD children after the 12-week course of synbiotic.
Eligibility
Age: 2 Years – 12 YearsHealthy volunteers accepted
Inclusion Criteria: 1. 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. 2. Elevated anxiety level, as measured by Anxiety Scale for Children-Autism Spectrum Disorder (ASC-ASD) 3. Presence of sensory hyperresponsiveness, as measured by Sensory Experience Questionnaire (SEQ) Exclusion Criteria: 1. Co-occurring mental retardation, neurological, psychosis, depression or other severe mental illness. 2. History of non-functional gastrointestinal disorders such as inflammatory bowel disease and Hirschsprung's disease. 3. Presence of other significant physical illness, including but not limited to: current active malignancy, immunosuppression, organ failure and epilepsy 4. Exposure to antibiotics within 1 months of the study or history of using probiotics. 5. On special diet such as being a vegetarian
Conditions2
AnxietyAutism Spectrum Disorder
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Actively Recruiting
PhaseN/A
SponsorChinese University of Hong Kong
Started2023-12-01
Est. completion2024-12-31
Eligibility
Age2 Years – 12 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06126185