Autism Clinical Risk Factors Investigation With Microbiome and Metabolome Profiling
Investigating Autism Clinical Risk Factors With Profiling the Intestinal Microbiome and Metabolome Analysis and Their Impact on Disease Severity and Clinical Outcomes in Autistic Egyptian Children
1 other identifier
observational
100
1 country
1
Brief Summary
The role of gut microbiome was recently raised in the pathogenesis of neurodevelopmental disorders including autism spectrum disorder (ASD). In view of these evidences, together with poor conductance of researches on gut microbiota in ASD patients in Egypt, in addition to the absence of definite medical test or biological marker for diagnosis of ASD, the present study is designed to study clinical risk factor of autism and the predominant gut microbiome in autistic children in an attempt to identify gut bacteria which are likely related to ASD and to correlate these bacteria and clinical variables with the severity of autism. Interestingly, the totality of the studies focusing on the fecal metabolome features in ASD has investigated the differences between subjects with and without this disorder, while ignoring potential correlations between microbiome, metabolome and ASD severity
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedFirst Posted
Study publicly available on registry
May 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2024
CompletedMay 8, 2023
May 1, 2023
1 year
April 14, 2023
May 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Autism clinical risk factors
prenatal, Natal and postnatal history then regression analysis
1 year
Secondary Outcomes (2)
Intestinal microbiome
1 year
metabolome Analysis
1 year
Interventions
no intervention
Eligibility Criteria
Autistic children aged between 3-9 years based on DSM V with variable degrees of disease severity
You may qualify if:
- a) Autistic children aged between 3-9 years based on DSM V
You may not qualify if:
- Past or present history of seizures or any other neurological illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ain shams University Hospitals (Unit of Phoniatrics-Otorhinolaryngology department )
Cairo, Egypt
Related Publications (1)
Ahmed SA, Elhefnawy AM, Azouz HG, Roshdy YS, Ashry MH, Ibrahim AE, Meheissen MA. Study of the gut Microbiome Profile in Children with Autism Spectrum Disorder: a Single Tertiary Hospital Experience. J Mol Neurosci. 2020 Jun;70(6):887-896. doi: 10.1007/s12031-020-01500-3. Epub 2020 Feb 15.
PMID: 32062762RESULT
Biospecimen
Stool Sample collection and storage * DNA Extraction * DNA amplification and amplicon sequencing * Bioinformatics processing of amplicon data
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
sara Eladawy, PhD
MSa university
- STUDY DIRECTOR
amira Abdeldaim, PhD
MSA university
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2023
First Posted
May 8, 2023
Study Start
May 1, 2023
Primary Completion
May 1, 2024
Study Completion
May 1, 2024
Last Updated
May 8, 2023
Record last verified: 2023-05