Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126185
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2023-11-06
Brief Title:
Open-label Pilot Study Synbiotic Treatment for Autism Spectrum Disorder
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Synbiotic Treatment for Neuropsychiatric Symptom of Autism Spectrum Disorder an Open-label Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None