Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-29 @ 3:54 AM
Study NCT ID:
NCT05849233
Status:
UNKNOWN
Last Update Posted:
2023-05-08
First Post:
2023-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autism Clinical Risk Factors Investigation With Microbiome and Metabolome Profiling
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000067877', 'term': 'Autism Spectrum Disorder'}, {'id': 'D001321', 'term': 'Autistic Disorder'}], 'ancestors': [{'id': 'D002659', 'term': 'Child Development Disorders, Pervasive'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Stool Sample collection and storage\n\n* DNA Extraction\n* DNA amplification and amplicon sequencing\n* Bioinformatics processing of amplicon data'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-05', 'studyFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2023-05-05', 'lastUpdatePostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autism clinical risk factors', 'timeFrame': '1 year', 'description': 'prenatal, Natal and postnatal history then regression analysis'}], 'secondaryOutcomes': [{'measure': 'Intestinal microbiome', 'timeFrame': '1 year', 'description': 'Stool Sample collection then intestinal microbiome investigation'}, {'measure': 'metabolome Analysis', 'timeFrame': '1 year', 'description': 'fecal metabolome analysis'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autism clinical risk factors', 'autism', 'microbiome', 'metabolome'], 'conditions': ['Autism Spectrum Disorder']}, 'referencesModule': {'references': [{'pmid': '32062762', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Autistic children aged between 3-9 years based on DSM V with variable degrees of disease severity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\na) Autistic children aged between 3-9 years based on DSM V\n\nExclusion criteria:\n\n1. Past or present history of seizures or any other neurological illness\n2. 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.'}, 'identificationModule': {'nctId': 'NCT05849233', 'briefTitle': 'Autism Clinical Risk Factors Investigation With Microbiome and Metabolome Profiling', 'organization': {'class': 'OTHER', 'fullName': 'October University for Modern Sciences and Arts'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RSPL 1.6'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Aya Adel, PhD', 'role': 'CONTACT', 'phone': '01012688291'}, {'name': 'Amira Abdeldaim, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sara Eladawy, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ain shams University Hospitals (Unit of Phoniatrics-Otorhinolaryngology department )', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'sara eladawy, PhD', 'role': 'CONTACT', 'email': 'smeladway@msa.edu.eg', 'phone': '01222124567'}, {'name': 'Amira Abdeldaim, PhD', 'role': 'CONTACT', 'phone': '01275055635'}], 'overallOfficials': [{'name': 'sara Eladawy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MSa university'}, {'name': 'amira Abdeldaim, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MSA university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October University for Modern Sciences and Arts', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ain Shams University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}