Autism Clinical Risk Factors Investigation With Microbiome and Metabolome Profiling

May 5, 2023 updated by: October University for Modern Sciences and Arts

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Amira Abdeldaim, PhD
  • Phone Number: 01275055635

Study Locations

  • Egypt
      • Cairo, Egypt
        • Ain shams University Hospitals (Unit of Phoniatrics-Otorhinolaryngology department )
        • Contact:
          • Aya Adel, PhD
          • Phone Number: 01012688291
        • Sub-Investigator:
          • Amira Abdeldaim, PhD
        • Sub-Investigator:
          • Sara Eladawy, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Autistic children aged between 3-9 years based on DSM V with variable degrees of disease severity

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autism clinical risk factors
Time Frame: 1 year
prenatal, Natal and postnatal history then regression analysis
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intestinal microbiome
Time Frame: 1 year
Stool Sample collection then intestinal microbiome investigation
1 year
metabolome Analysis
Time Frame: 1 year
fecal metabolome analysis
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

October University for Modern Sciences and Arts

Collaborators

Ain Shams University

Investigators

  • Principal Investigator: sara Eladawy, PhD, MSA University
  • Study Director: amira Abdeldaim, PhD, MSA University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2023

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

April 14, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 5, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RSPL 1.6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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