Evaluating synbiotic treatment for anxiety in children with autism
Synbiotic Treatment for Neuropsychiatric Symptom of Autism Spectrum Disorder: an Open-label Pilot Study
This study is testing if a new treatment using synbiotics can help reduce anxiety in children with autism who are under 12 years old.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 2 Years to 12 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06126185 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the feasibility, tolerability, and preliminary efficacy of a 12-week synbiotic treatment in improving anxiety symptoms among children diagnosed with Autism Spectrum Disorder (ASD). The study will recruit 30 children under 12 years of age from a regional psychiatric clinic, focusing on those with elevated anxiety levels and sensory hyperresponsiveness. Participants will undergo a course of synbiotic, with outcomes measured through standardized questionnaires and analysis of fecal microbiome changes at weeks 6 and 12.
Who should consider this trial
Good fit: Ideal candidates are Chinese children under 12 years old diagnosed with ASD and exhibiting elevated anxiety levels.
Not a fit: Patients with co-occurring severe mental illnesses or significant physical health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel approach to alleviating anxiety symptoms in children with autism, potentially improving their overall quality of life.
How similar studies have performed: While the approach of using synbiotics for anxiety in ASD is relatively novel, emerging evidence suggests potential benefits from gut microbiota interventions in related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hong Kong
- The Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Wing Ho Wong, MBChB — Chinese University of Hong Kong
- Study coordinator: Wing Ho Wong, MBChB
- Email: oscarwhwong@cuhk.edu.hk
- Phone: 85226076034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.