Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT04603456
Status:
COMPLETED
Last Update Posted:
2020-10-29
First Post:
2020-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
miRNA-155 Assay Before and After Immunotherapy and Probiotics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group I included 15 cases who received probiotics only. Group II included 15 children who received SLIT. Group III included 15 children who received probiotics and SLIT.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-27', 'studyFirstSubmitDate': '2020-10-11', 'studyFirstSubmitQcDate': '2020-10-20', 'lastUpdatePostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total nasal symptom score between before and after treatment', 'timeFrame': '6 months', 'description': 'Total Nasal Symptom Score was evaluated for the three groups at the start of the study and after 6 months. TNSS is the sum of scores for each of nasal obstruction, sneezing, nasal itching, and rhinorrhea at each time point, by means of a four-point scale (0-3) . TNSS is estimated by addition of the score for each of the symptoms to a total out of 12'}], 'secondaryOutcomes': [{'measure': 'Serum miR-155 expression at the start and end of the study', 'timeFrame': '6 months', 'description': 'Serum miR-155 expression was measured for the three groups by quantitative real time PCR'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '11846609', 'type': 'BACKGROUND', 'citation': 'Livak KJ, Schmittgen TD. Analysis of relative gene expression data using real-time quantitative PCR and the 2(-Delta Delta C(T)) Method. Methods. 2001 Dec;25(4):402-8. doi: 10.1006/meth.2001.1262.'}, {'pmid': '18417051', 'type': 'BACKGROUND', 'citation': 'Cox L. Sublingual immunotherapy and allergic rhinitis. Curr Allergy Asthma Rep. 2008 Apr;8(2):102-10. doi: 10.1007/s11882-008-0019-5.'}]}, 'descriptionModule': {'briefSummary': 'The investigators aimed to explore miRNA-155 change in response to sublingual immunotherapy (SLIT), probiotics and combined treatment with SLIT and probiotics in AR children.', 'detailedDescription': 'Allergic rhinitis (AR) is an inflammatory state characterized by a disturbance of immunoregulatory mechanisms that leads to an amplified T helper "Th-2" response. Micro-RNAs (miRNAs) are short single-stranded RNA molecules that post transcriptionally control gene expression and can mediate allergic process. The aim of this study was to explore miRNA-155 change in response to sublingual immunotherapy (SLIT), probiotics and combined treatment with SLIT and probiotics in AR children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 5-18 years\n* Diagnosed as having AR\n* With positive skin test to grass pollen\n\nExclusion Criteria:\n\n* Anatomical abnormalities of upper respiratory tract,\n* Previous immunotherapy,\n* Clinically significant inflammatory diseases,\n* Malignancies,\n* Chronic treatment with systemic corticosteroids or immune suppressive drugs'}, 'identificationModule': {'nctId': 'NCT04603456', 'briefTitle': 'miRNA-155 Assay Before and After Immunotherapy and Probiotics', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'MicroRNA-155 Assay in Childhood Allergic Rhinitis Before and After Combined Sublingual Immunotherapy and Probiotics', 'orgStudyIdInfo': {'id': 'miR-155 in allergic rhinitis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic Group', 'description': 'consisted of 15 cases who received probiotics only. A drug called Lacteol fort (Rameda Company) . A sachet was taken once daily for three months. Each sachet contains 10 billions lactobacilli.', 'interventionNames': ['Drug: Lacteol fort']}, {'type': 'EXPERIMENTAL', 'label': 'SLIT Group', 'description': 'included 15 children who received SLIT for 6 months. Standardized Timothy Grass Pollen (Phleum pratense)', 'interventionNames': ['Drug: Standardized Timothy Grass Pollen']}, {'type': 'EXPERIMENTAL', 'label': 'Combined treatment Group', 'description': 'included 15 children who received probiotics and SLIT. A drug called Lacteol fort was administered A sachet was taken once daily for 3 months . Standardized Timothy Grass Pollen was taken for 6 months', 'interventionNames': ['Drug: Lacteol fort and Standardized Timothy Grass Pollen']}], 'interventions': [{'name': 'Lacteol fort', 'type': 'DRUG', 'description': 'Lacteol fort is a drug containing lactobacilli', 'armGroupLabels': ['Probiotic Group']}, {'name': 'Standardized Timothy Grass Pollen', 'type': 'DRUG', 'description': 'SLIT includes 2 phases build up and maintenance phases. (Jubilant HollisterStier LLC 14110 Collections Drive, Chicago USA) .', 'armGroupLabels': ['SLIT Group']}, {'name': 'Lacteol fort and Standardized Timothy Grass Pollen', 'type': 'DRUG', 'description': 'Lacteol fort is a drug containing lactobacilli and the Standardized Timothy Grass Pollen includes 2 phases build up and maintenance phases.', 'armGroupLabels': ['Combined treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Zagazig university', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Randa Sedeek', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical Microbiology and Immunology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant lecturer', 'investigatorFullName': 'Fedaa Nabil', 'investigatorAffiliation': 'Zagazig University'}}}}