NCT06126185Completed
Open-label Pilot Study Synbiotic Treatment for Autism Spectrum Disorder
Synbiotic Treatment for Neuropsychiatric Symptom of Autism Spectrum Disorder: an Open-label Pilot Study
Source: ClinicalTrials.gov · Last updated 2 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 30 (actual)
- First submitted
- 6 Nov 2023
- Start date
- 1 Dec 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Chinese University of Hong Kong
- Diseases
- Autism
- NCT number
- NCT06126185
What you commit to
- Study type: Interventional
- Participants enrolled: 30
- From 1 Dec 2023 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- On special diet such as being a vegetarian
Who the study is looking for
- 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)
Age in the registry: 2 years to 12 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.