Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-25 @ 7:11 PM
Study NCT ID:
NCT00224432
Status:
COMPLETED
Last Update Posted:
2006-09-27
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-09', 'completionDateStruct': {'date': '2002-09'}, 'lastUpdateSubmitDate': '2006-09-26', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2006-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Significant decrease of SCORAD score in treated infants compared to placebo'}], 'secondaryOutcomes': [{'measure': 'IL-4, IL-5 and IFN-gamma production of stimulated peripheral blood mononuclear cells'}, {'measure': 'change in fecal TNF-α and α-1-antitrypsin, urinary EDN'}, {'measure': 'effect on faecal bacteria after probiotics'}]}, 'conditionsModule': {'keywords': ['Atopic Dermatitis', 'SCORAD', 'probiotics', 'cytokines', 'Infant'], 'conditions': ['Atopic Dermatitis', 'Atopic Eczema', 'Infantile Eczema']}, 'referencesModule': {'references': [{'pmid': '16839405', 'type': 'RESULT', 'citation': 'Brouwer ML, Wolt-Plompen SA, Dubois AE, van der Heide S, Jansen DF, Hoijer MA, Kauffman HF, Duiverman EJ. No effects of probiotics on atopic dermatitis in infancy: a randomized placebo-controlled trial. Clin Exp Allergy. 2006 Jul;36(7):899-906. doi: 10.1111/j.1365-2222.2006.02513.x.'}]}, 'descriptionModule': {'briefSummary': 'To study the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA and to compare effectiveness of different strains of probiotics.', 'detailedDescription': "* To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological parameters in infants with AD with and without CMA\n* To determine the effect of supplementation of a hydrolyzed formula with probiotic bacteria on clinical and immunological reactivity to cow' milk challenge in infants with AD with CMA\n* To compare the effectiveness of different strains of probiotic bacteria in improving clinical and immunological outcome in these infants"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Months', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Term infants fulfilling the Hanifin (1989) criteria for atopic dermatitis\n\n * Suggestive of CMA (one additional symptom)\n * Scorad index (total) \\>20 at study entry\n * Below 5 months of age\n * Formula, not breast fed\n * Written informed consent from the parents\n\nExclusion Criteria:\n\n* • Previous or current use of anti-histamines, oral corticosteroids, probiotics\n\n * Use of systemic antibiotic or anti-mycotic drugs in the previous 4 weeks\n * Congenital intestinal abnormality (eg. Hirschsprung's disease, intestinal atresia)\n * Other GI disease with intestinal inflammation and/or increased intestinal permeability\n * Skin disorder, not atopic dermatitis\n * Participation in another clinical study"}, 'identificationModule': {'nctId': 'NCT00224432', 'briefTitle': 'Double-Blind, Parallel, Randomised Study to Investigate the Effect of Oral Probiotics in Infants With Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Groningen Research Institute for Asthma and COPD'}, 'officialTitle': "Double-Blind, Parallel, Randomised Study to Investigate the Clinical and Immunological Effects of Oral Administration of Probiotic Bacteria in Infants With Atopic Dermatitis With and Without Cow's Milk Allergy.", 'orgStudyIdInfo': {'id': 'METc/99/07/116'}}, 'armsInterventionsModule': {'interventions': [{'name': 'probiotics: Lactobacillus GG, lactobacillus Rhamnosus', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9700 RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': "Beatrix Children's Hospital, University Medical Center Groningen", 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Eric J Duiverman, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands'}, {'name': 'Marianne L Brouwer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Pediatric Pulmonology, University Medical Center Groningen, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groningen Research Institute for Asthma and COPD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Numico Research Wageningen, the Netherlands', 'class': 'UNKNOWN'}]}}}