Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419530
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-13
Brief Title:
A Study on Probiotic Formula in Autistic Children
Sponsor:
Third Military Medical University
Organization:
Third Military Medical University
Study Overview
Official Title:
A Double-blind Randomized Clinical Trail Study on the Effectiveness and Safety of Probiotic Formula in Autistic Children With Gastrointestinal Symptoms
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
A Randomized controlled double-blind clinical study on the effectiveness and safety of probiotic formula in Autistic children with gastrointestinal symptoms
Detailed 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 formulaFMTplacebo 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 ChecklistABCChildhood Autism Rating ScaleCARSGastrointestinal Symptom Rating ScaleGSRSSocial Responsiveness ScaleSRSSelf-Rating Anxiety ScaleSAS and Autism Diagnostic Observation ScheduleADOS and blood and fecal samples collection
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