Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-13 @ 7:48 AM
Study NCT ID:
NCT02519556
Status:
COMPLETED
Last Update Posted:
2021-01-28
First Post:
2015-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}, {'id': 'C008315', 'term': 'maltodextrin'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2015-08-04', 'studyFirstSubmitQcDate': '2015-08-06', 'lastUpdatePostDateStruct': {'date': '2021-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SCORAD', 'timeFrame': '1 year', 'description': 'Change from baseline in SCORAD every 3 months for 1 year'}], 'secondaryOutcomes': [{'measure': 'Skin prick test (immediate awareness)', 'timeFrame': '1 year'}, {'measure': 'Inflammation composite', 'timeFrame': '1 year', 'description': 'ɣ - IFN, IL-1β, IL -4 , IL -6, IL-8 and tumor necrosis factor'}, {'measure': 'Immune tolerance composite', 'timeFrame': '1 year', 'description': 'IL-10, TGF - β and IL -17'}, {'measure': 'Total serum IgE', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Probiotics', 'Inflammation', 'Awareness', 'Immune tolerance'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'Atopic dermatitis (AD) is an immune disorder, characterized by chronic skin inflammation or relapsing, whose prevalence is increasing worldwide. Its exact etiology remains unknown. The hypothesis that an appropriate early stimulation of the intestinal flora contributes to the establishment of the immune system balance has led to the use of probiotics in the prevention and treatment of AD in several clinical and experimental studies.\n\nTherefore, the objectives of this study will evaluate the clinical efficacy of the mixture of probiotics (Lactobacillus and Bifidobacterium) in children with AD through the SCORAD (scoring atopic dermatitis) and to evaluate the effects of this medication in the following laboratory parameters: skin prick test, total serum immunoglobulin E (IgE), inflammation composite (interferon gamma \\[ɣ - IFN\\], interleukins \\[IL1-β, IL-4, IL-6, IL-8\\] and tumor necrosis factor alpha) and immune tolerance composite (IL-10, IL-17 and transforming growth factor beta \\[TGF - β\\]).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Atopic Dermatitis\n* Children over 6 months.\n* Teens lower than 19 years\n\nNo inclusion / Exclusion Criteria:\n\n* Diagnostic presence or clinical signs suggesting acute or chronic skin diseases, as well as pertinent to the study, which may affect the outcome of the research.\n* Being in use of drugs that can affect systemically in the course of the disease, such as systemic corticosteroids and immunosuppressants, for at least 30 days.\n* Allergy or severe adverse reactions attributable to the administration of the probiotic.\n* Non adherence to treatment (ie not present regular use, as prescribed) for at least one continuous month.\n* Lack of attendance by more than 50% of ratings (clinical and/or laboratory) to be held during the search.\n* Patient's request (or responsible's request)"}, 'identificationModule': {'nctId': 'NCT02519556', 'briefTitle': 'Trial on Effectiveness Combined Probiotics in Atopic Dermatitis in Children', 'organization': {'class': 'OTHER', 'fullName': 'Casa Espirita Terra de Ismael'}, 'officialTitle': 'Randomized, Double Blind, Controlled Trial on Effectiveness Combined Probiotics in the Treatment of Atopic Dermatitis in Children', 'orgStudyIdInfo': {'id': 'ProbioticsAD2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiatop', 'description': 'Probiotic comprising the mixture of strains: Lactobacillus rhamnosus, Lactobacillus acidophilus, Lactobacillus paracasei and Bifidobacterium lactis, at a dose of 1 gram sachet, once a day for 6 months', 'interventionNames': ['Drug: Probiatop']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo of Maltodextrin in sachet', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Probiatop', 'type': 'DRUG', 'otherNames': ['Probiotics'], 'description': 'Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months.', 'armGroupLabels': ['Probiatop']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Maltodextrin'], 'description': '1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14048-900', 'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas FMRP-USP', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}], 'overallOfficials': [{'name': 'Paula A Andrade, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HCFMRP-USP'}, {'name': 'Persio Roxo-Junior, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HCFMRP-USP'}, {'name': 'Vanessa Carregaro, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'USP-RP'}, {'name': 'Jorgete Maria e Silva, MD, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'HCFMRP-USP'}, {'name': 'Luciana Roberti', 'role': 'STUDY_CHAIR', 'affiliation': 'FMRP-USP'}, {'name': 'Laís Sacramento, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'USP-RP'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Casa Espirita Terra de Ismael', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sao Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University of Sao Paulo', 'investigatorFullName': 'Fabio Carmona', 'investigatorAffiliation': 'Casa Espirita Terra de Ismael'}}}}