Autism Spectrum DisorderNCT05849233
Autism Clinical Risk Factors Investigation With Microbiome and Metabolome Profiling
An observational study of Autism Spectrum Disorder, run by October University for Modern Sciences and Arts at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Autism Spectrum Disorder
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Autistic children aged between 3-9 years based on DSM V with variable degrees of disease severity
Who may be able to join
- Autistic children aged between 3-9 years based on DSM V
Who cannot join
- Past or present history of seizures or any other neurological illness
- 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.
Trial locations and contacts
1 site in 1 country.
Amira Abdeldaim, PhD contact
Egypt1 site
Ain shams University Hospitals (Unit of Phoniatrics-Otorhinolaryngology department )
Cairo
Aya Adel, PhD, 01012688291
Amira Abdeldaim, PhD
About this study
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
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
Read the 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
- Being tested
- no intervention
- Keywords
- Autism clinical risk factors, autism, microbiome, metabolome
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Autism clinical risk factors
prenatal, Natal and postnatal history then regression analysis
Measured: 1 year
Secondary outcomes (2)
Intestinal microbiome
Stool Sample collection then intestinal microbiome investigation
Measured: 1 year
metabolome Analysis
fecal metabolome analysis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 May 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October University for Modern Sciences and Arts
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor
- Investigators
- sara Eladawy, PhD, Principal investigator, MSa universityamira Abdeldaim, PhD, Study director, MSA university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849233
- Sponsor's protocol ID
- RSPL 1.6
- Status last verified
- May 2023
- First submitted
- 14 Apr 2023
- Last updated
- 8 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32062762
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05849233
- Acronym / sponsor ID
- RSPL 1.6
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism clinical risk factors, autism, microbiome, metabolome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- October University for Modern Sciences and ArtsUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Autistic children aged between 3-9 years based on DSM V with variable degrees of disease severity
Key inclusion criteria (1 listed)
- Autistic children aged between 3-9 years based on DSM V
Key exclusion criteria (2 listed)
- Past or present history of seizures or any other neurological illness
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Autism clinical risk factors
Time frame: 1 year
prenatal, Natal and postnatal history then regression analysis
2 secondary outcomes
Intestinal microbiome
Time frame: 1 year
metabolome Analysis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Results publication: PubMed 32062762Ahmed 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amira Abdeldaim, PhD contact
sara Eladawy, PhD principal investigator
MSa university
amira Abdeldaim, PhD study director
MSA university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder, run by October University for Modern Sciences and Arts at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sara eladawy, PhD (01222124567, smeladway@msa.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism clinical risk factors (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05849233, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.