Autism Clinical Risk Factors Investigation With Microbiome and Metabolome Profiling

NCT ID: NCT05849233

Last Updated: 2023-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-05-01

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

Detailed 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.

Conditions

Autism Spectrum Disorder

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Interventions

no intervention

no intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: collaborator

October University for Modern Sciences and Arts

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

sara Eladawy, PhD

Role: PRINCIPAL_INVESTIGATOR

MSa university

amira Abdeldaim, PhD

Role: STUDY_DIRECTOR

MSA university

Locations

Ain shams University Hospitals (Unit of Phoniatrics-Otorhinolaryngology department )

Cairo, , Egypt

Countries

Egypt

Central Contacts

sara eladawy, PhD

Role: CONTACT

smeladway@msa.edu.eg

01222124567

Amira Abdeldaim, PhD

Role: CONTACT

01275055635

Facility Contacts

Aya Adel, PhD

Role: primary

01012688291

References

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.

Reference Type: RESULT

PMID: 32062762 (View on PubMed)

Other Identifiers

RSPL 1.6

Identifier Type: -

Identifier Source: org_study_id