Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT05794620
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-09-19
First Post:
2023-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings
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_WITHOUT_DNA', 'description': 'Faecal samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-06', 'studyFirstSubmitDate': '2023-03-20', 'studyFirstSubmitQcDate': '2023-03-30', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Gut microbiota', 'timeFrame': '6 weeks', 'description': 'Gut microbiota composition of faeces of children with ASD'}], 'primaryOutcomes': [{'measure': 'Gut microbiota', 'timeFrame': '0 weeks', 'description': 'Gut microbiota composition of faeces of children with ASD'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autism Spectrum Disorder', 'Autism']}, 'descriptionModule': {'briefSummary': 'This study aims to accurately characterise the gut microbiota composition of faeces of children with ASD and compare it with the gut microbiota composition of their neurotypical siblings. In addition it aims to also characterise the metagenome and metabolome of the faeces of both ASD and neurotypical siblings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with ASD', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children of both sexes who are diagnosed with ASD and under the care of ESNEFT who have a neurotypical sibling (either full or half sibling), who share their living environment. This is due to the study requiring stool samples that are from siblings, to control for genes and environment where possible.\n* Aged 3 years to 10 years old (at time of consent)\n* Parent/guardian able to consent to participate\n* Parent/guardian able to complete required surveys (or with accommodated adjustments)\n\nExclusion Criteria:\n\n* Use of antibiotics in the previous 4 weeks\n* Not under the care of ESNEFT\n* Children \\<3 years old and \\>10 years old\n* Children that don't have half or full siblings\n* Parent/guardian unable to provide informed consent or complete surveys, despite reasonable adjustments being implemented"}, 'identificationModule': {'nctId': 'NCT05794620', 'acronym': 'FAMILY', 'briefTitle': 'Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings', 'organization': {'class': 'OTHER', 'fullName': 'East Suffolk and North Essex NHS Foundation Trust'}, 'officialTitle': 'Faecal Microbiota Analysis in Neurotypical and Autism Syndrome Disorder Siblings: FAMILY', 'orgStudyIdInfo': {'id': '22/045'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with Autism', 'description': 'A child with a diagnosis of Autism', 'interventionNames': ['Other: Stool sample']}, {'label': 'Neurotypical siblings', 'description': 'A full sibling of the child with Autism', 'interventionNames': ['Other: Stool sample']}], 'interventions': [{'name': 'Stool sample', 'type': 'OTHER', 'description': 'Stool sample', 'armGroupLabels': ['Children with Autism', 'Neurotypical siblings']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Colchester', 'country': 'United Kingdom', 'facility': 'East Suffolk and North Essex Nhs Foundation Trust', 'geoPoint': {'lat': 51.88921, 'lon': 0.90421}}], 'overallOfficials': [{'name': 'Ben Marlow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Suffolk and North Essex NHS Foundation Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Suffolk and North Essex NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Quadram Institute Bioscience', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}