Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT03277820
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2017-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010034', 'term': 'Otitis Media with Effusion'}], 'ancestors': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Investigator does not know which subjects administered probiotics'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2017-09-07', 'studyFirstSubmitQcDate': '2017-09-07', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiome differences', 'timeFrame': '4 years', 'description': 'After Illumina MiSeq sequencing, bio-informatic tools will be used to cluster bacteria into operational taxonomic units (OTUs). Based on these OTUs, we will compare the composition of the bacteria in the sampled niches and compare this composition between patient with and without intake of probiotics. We will specifically screen for OTUs that are over- or underrepresented in both populations. Furthermore, special attention will go to screen for the typical nasopharyngeal pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis... and also to beneficial microbes such as lactic acid bacteria.'}], 'secondaryOutcomes': [{'measure': 'Differences in absolute concentration of otitis media pathogens', 'timeFrame': '4 years', 'description': 'After DNA extraction of the biological samples, the absolute concentration of the administered probiotics and otitis media pathogens will be monitored via qPCR. This will give information about the capacity of the probiotics to colonise the nasopharynx and to alter the concentration of pathogens.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Otitis Media With Effusion', 'Probiotics', 'Adenoid Vegetations']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether the microbiota in the upper respiratory tract (nasopharynx, adenoids and middle ear fluid) of otitis media with effusion (OME) patients is changed after 4 weeks of probiotic product intake. Therefore, bacterial DNA from swabs, fluid and tissue will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Furthermore, the concentration of specific pathogens will be monitored via qPCR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children with otitis media with effusion\n* children with adenoid hypertrophy\n\nExclusion Criteria:\n\n* no patients with trisomy 21'}, 'identificationModule': {'nctId': 'NCT03277820', 'briefTitle': 'Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Effect of Probiotics on Microbiome of Adenoid Tissue and Middle Ear Fluid of Children With Otitis Media With Effusion', 'orgStudyIdInfo': {'id': 'B300201731908'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic group', 'description': 'Intake of 1 portion (=6 droplets) Probactiol Mini during 4 weeks.', 'interventionNames': ['Dietary Supplement: Probactiol Mini']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No intake of Probactiol Mini'}], 'interventions': [{'name': 'Probactiol Mini', 'type': 'DIETARY_SUPPLEMENT', 'description': '6 droplets of Probactiol Mini contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)', 'armGroupLabels': ['Probiotic group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'country': 'Belgium', 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. dr. An Boudewyns, MD, PhD', 'investigatorFullName': 'ethisch.comite@uza.be', 'investigatorAffiliation': 'University Hospital, Antwerp'}}}}