Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2025-12-25 @ 7:23 PM
Study NCT ID:
NCT01224132
Status:
COMPLETED
Last Update Posted:
2010-10-19
First Post:
2010-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Probiotics in the Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-18', 'studyFirstSubmitDate': '2010-10-18', 'studyFirstSubmitQcDate': '2010-10-18', 'lastUpdatePostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atopic dermatitis, probiotic, SCORAD index, prick tests, cytokines'], 'conditions': ['Atopic Dermatitis, Probiotics']}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the efficacy of probiotics in the treatment of atopic dermatitis. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.', 'detailedDescription': 'Frequently encountered in clinical practice, in the last 30 years, the prevalence of AD has rapidly increased as a result of industrialization. Thus, a new wave of quests for the treatment and prevention of AD has pushed forward. For the randomized, double-blinded, and placebo-controlled study this study was designed to evaluate the efficacy of probiotics in the treatment of AD. SCORAD positivity index of decline rates decline rates of the probiotic group of patients after treatment and skin prick tests were higher than that of the control group. While serum levels of IL-2-4-5-6-10, TNF-α, IFN-γ, ECP decreased in the probiotic group, only levels of IL-2-4-5, TNF-α decreased in the control group. The IgE decrease rate, the skin prick test, the serum total and specific of the probiotic group showed no difference from those of the control group. Probiotics in AD patients were effective in reducing SCORAD index levels, but not effective in skin prick test positivity, serum IL-2-4-5-6-10, TNF-α, IFN-γ, ECP, and serum total and specific IgE levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Weeks', 'minimumAge': '8 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:SCORAD (SCORing Atopic Dermatitis) index is based on medium-heavy (Carr 2006). Age range is 1-13 with no patient showing evidence of any other disease except the existent disease -\n\nExclusion Criteria:No drug was used for 14 (fourteen) days prior to study, including antihistamines and steroids. Also, no occurrence of malabsorption, such as gastrointestinal disease, was detected.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01224132', 'briefTitle': 'Effect of Probiotics in the Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Effect of Probiotics in the Treatment of Children With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'JID-2010-0484'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Probiotics', 'interventionNames': ['Drug: probiotic ® pur']}, {'type': 'NO_INTERVENTION', 'label': 'skim milk powder, dextrose', 'interventionNames': ['Drug: probiotic ® pur']}], 'interventions': [{'name': 'probiotic ® pur', 'type': 'DRUG', 'description': 'daily, four types of probiotic bacteria ( Bifidobacterium bifidity, Lactobacillus acidophilus, Lactobacillus casei and Lactobacillus salivarium) 2 bags (two billion bacteria) (probiotic ® pur) for a total of 8 (eight) weeks', 'armGroupLabels': ['Probiotics', 'skim milk powder, dextrose']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': "Yuzuncu Yıl of the University Rector's Office of Scientific Research Department", 'oldOrganization': "Yuzuncu Yıl of the University Rector's Office of Scientific Research Department"}}}}