CompletedNot Applicable

Open-label Pilot Study Synbiotic Treatment for Autism Spectrum Disorder

Hong Kong30 participantsStarted 2023-12-01

Plain-language 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.

Who can participate

Age range2 Years – 12 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Incidence of adverse events and side effect

Timeframe: At week 6 and week 12 of the 12-week course of synbiotic

Trial details

NCT IDNCT06126185

SponsorChinese University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Autism Spectrum Disorder trials