NCT06126185

Open-label Pilot Study Synbiotic Treatment for Autism Spectrum Disorder

Synbiotic Treatment for Neuropsychiatric Symptom of Autism Spectrum Disorder: an Open-label Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Accepted

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.

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 target of ASD children is co-occurring neuropsychiatric disorders, which would interact with the core symptoms to further jeopardize their social and educational development. In pre-pubertal children, anxiety disorder is one of the commonest co-occurring psychiatric disorders without effective therapeutics. Anxiety symptoms is related to sensory hyperresponsiveness, and emerging evidence has shown that sensory atypicality in ASD could be contributed by the altered gut microbiota. Thus, intervention that targets the gut microbiota may improve the clinical anxiety symptoms in ASD children. In this study, a pilot open-label trial will be conducted. It is planned that 30 ASD children who are below 12 years of age will be recruited from a regional children psychiatric specialist clinic to undergo a 12-week course of synbiotic. Feasibility, tolerability and preliminary efficacy of the synbiotic will be investigated using standardised parent-filled questionnaires. Changes in fecal microbiome and metabolites will be observed. The outcomes will be measured at weeks 6 and 12 of the 12-week course of synbiotic. The results of the proposed study will provide insights with regards to the design and implementation of the main randomised controlled trial (RCT), contributing to the generation of evidence to the real-life efficacy the synbiotic. Physiological measurements of gut metagenomics and metabolomics will shed light on the specific mechanisms underlying clinical efficacies, which could inform the development of novel therapeutics targeting the microbiota-gut-brain axis in ASD.

Conditions

• Autism Spectrum Disorder
• Anxiety

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	12-week course of synbiotic	A 12-week-course of synbiotic, which contains containing 5 billion colony-forming unit (CFU) of a combination of 4 probiotic species belonging to the genus of Lactobacillus, Bifidobacterium and Streptococcus, and 3 prebiotics, will be given to participants to take daily through oral route.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-12-31
• Completion: 2025-07-31
• First posted: 2023-11-13
• Last updated: 2026-04-02

Locations

1 site across 1 country: Hong Kong