Autism Clinical Risk Factors Investigation With Microbiome and Metabolome Profiling

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05849233
• Other study ID #: RSPL 1.6
• Status: Not yet recruiting
• Start date: May 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2023
• Source: October University for Modern Sciences and Arts
• Contact: sara eladawy, PhD
• Phone: 01222124567
• Email: smeladway[@]msa.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Autism spectrum disorder (ASD) is a group of neurodevelopmental disorders characterized by impairment in communication and social interaction, and repetitive behaviors. 1%-1.5% of children in developed nations has ASD, This rate is said to range between 0.15% and 0.8% in low- and middle-income countries. Over the past decades, the prevalence of ASD has increased worldwide. Scientists have been trying to explore the molecular mechanisms behind the pathology of ASD. Several evidence suggests that genetic factors such as chromosomal abnormalities and environmental factors like diet and stress are involved in the pathogenesis and advancement of ASD. Accumulating research has demonstrated the gut-brain axis or multiple biochemical signaling pathways that take place between the gastrointestinal tract (GI tract) and the central nervous system (CNS), and its possible association with ASD. Mounting evidence explains that gut microbial dysbiosis is implicated in the pathogenesis of multiple diseases, including inflammatory bowel disease (IBS), coeliac disease (CD), and ASD. A Recent Egyptian study showed that an evidence of changes in the gut microbiome of ASD children compared to the unrelated controls. However, the microbiome profile of siblings was more like that of autistic children than that of unrelated controls. These observations may highlight the importance of the interplay between environmental and host genetic factors in shaping the gut microbiome. The study also emphasized the importance of identification of microbiome and specific microorganisms' changes that can be targeted for diagnosis as well as for treatment of ASD. This study aims to investigate clinical risk factors of autism and to elucidate the changes in gut microbiome in Egyptian autistic children and their possible correlation with clinical outcomes and the severity of the disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

Inclusion criteria:

a) Autistic children aged between 3-9 years based on DSM V

Exclusion criteria:

1. Past or present history of seizures or any other neurological illness

2. Past or present history of any psychiatric illness Those patient will be excluded to avoid confounders because those diseases also affected by microbiome The inclusion and exclusion criteria will be determined by the medical history taken from the parents of the children before test application.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
Egypt	Ain shams University Hospitals (Unit of Phoniatrics-Otorhinolaryngology department )	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
October University for Modern Sciences and Arts	Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & 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/s12 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Autism clinical risk factors	prenatal, Natal and postnatal history then regression analysis	1 year
Secondary	Intestinal microbiome	Stool Sample collection then intestinal microbiome investigation	1 year
Secondary	metabolome Analysis	fecal metabolome analysis	1 year