A Study on Probiotic Formula in Autistic Children

Status Not yet recruiting

Clinical Trial Summary

A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms.

Clinical Trial Description

Autism spectrum disorder (ASD) is a neurodevelopmental disorder of children with estimated prevalence of near 1% by WHO in 2022. To date, the cause and etiology of ASD is still unknown, and there is no proven effective pharmacological treatment for ASD. The gut microbiota has been proved to have great impact on neurological development, in this study, we aim to explore the effectiveness of safety of probiotic formula on ASD children, by comparing with placebo and fecal microbiota transplantation (FMT). This study will be a randomized, double-blind, placebo-controlled trial. Totally, 156 Autistic children with gastrointestinal symptoms will be enrolled and randomly allocated into three groups: probiotic formula group, fecal microbiota transplantation (FMT) group and placebo group. participants are treated with 4 probiotic formula/FMT/placebo capsules each day, for 84 days. Participants would be followed up at the 4th, 8th, 12th and 24th week after enrollment by simple physical examination, relevant scale questionaire (including Autism Behavior Checklist(ABC),Childhood Autism Rating Scale(CARS),Gastrointestinal Symptom Rating Scale(GSRS),Social Responsiveness Scale(SRS),Self-Rating Anxiety Scale(SAS) and Autism Diagnostic Observation Schedule(ADOS)), and blood and fecal samples collection. ;

Study Design

Related Conditions & MeSH terms

Autism Spectrum Disorder

Clinical Trial Details

NCT number	NCT06419530
Study type	Interventional
Source	Third Military Medical University
Contact	Yanling Wei, MD
Phone	15310354666
Email	lingzi016@126.com
Status	Not yet recruiting
Phase	N/A
Start date	June 2024
Completion date	June 2028

View Details

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