Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-10 @ 5:11 PM
Study NCT ID:
NCT01148667
Status:
COMPLETED
Last Update Posted:
2010-06-22
First Post:
2010-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-21', 'studyFirstSubmitDate': '2010-06-21', 'studyFirstSubmitQcDate': '2010-06-21', 'lastUpdatePostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'severity of atopic dermatitis', 'timeFrame': 'March 2007 - July 2008', 'description': 'Severity of atopic dermatitis of the study infants will be assessed by SCORAD index'}], 'secondaryOutcomes': [{'measure': 'Maturation of humoral immune responses', 'timeFrame': 'March 2007 - July 2008', 'description': 'Determination of proportions of immunoglobulin secreting cells among peripheral blood mononuclear cells was carried out by ELISPOT assay. The proportions of CD 19+ memory B cells was carried out by flow cytometry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atopic dermatitis', 'barrier function', 'gut', 'probiotics', 'skin'], 'conditions': ['Gut Microbiota', 'Skin Microbiota', 'Humoral Immune Responses', 'Severity of Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '21121981', 'type': 'DERIVED', 'citation': 'Nermes M, Kantele JM, Atosuo TJ, Salminen S, Isolauri E. Interaction of orally administered Lactobacillus rhamnosus GG with skin and gut microbiota and humoral immunity in infants with atopic dermatitis. Clin Exp Allergy. 2011 Mar;41(3):370-7. doi: 10.1111/j.1365-2222.2010.03657.x. Epub 2010 Dec 1.'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis: Probiotics have been used as novel adjunct therapeutic approach in atopic dermatitis. In addition to balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary infections which typically cause sustained symptoms.\n\nThirty-nine infants with atopic dermatitis,randomized for a three-month-period in a double-blind design to receive extensively hydrolysed casein formula (NutramigenR, Mead-Johnson, USA) supplemented with (n=19) or without (n=20) Lactobacillus rhamnosus GG (ATCC 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu.\n\nSampling (blood and faecal samples, cotton swab from the skin) and clinical examination of the infant, including SCORAD assessment to determine the severity of atopic dermatitis, at each study visit (at entry and one month and three months thereafter).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '4 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of atopic dermatitis\n* age 4 we - 18 mo\n\nExclusion Criteria:\n\n* skin infection or severe infection at the time of enrollment'}, 'identificationModule': {'nctId': 'NCT01148667', 'briefTitle': 'Lactobacillus Rhamnosus GG: Interaction With Human Microbiota and Immunity', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turku University Hospital'}, 'officialTitle': 'Interaction of Orally Administered Lactobacillus Rhamnosus GG With Skin and Gut Microbiota and Humoral Immunity in Infants With Atopic Dermatitis', 'orgStudyIdInfo': {'id': '12/2006 1 531'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Infants drink formula added with LGG', 'description': 'Infants have been randomized (1:1) to get casein hydrolysate with or without LGG', 'interventionNames': ['Dietary Supplement: Casein hydrolysate added with LGG']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Infants drink casein hydrolysate without LGG', 'description': 'Infants get extensively hydrolysed casein formula', 'interventionNames': ['Dietary Supplement: Infants drink casein hydrolysate without LGG']}], 'interventions': [{'name': 'Casein hydrolysate added with LGG', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infants drink extensively hydrolysed casein formula supplemented with LGG (ATCC 53103) 5.0 x 10 7 cfu/g to achieve a daily intake of 3.4 10 9 cfu.', 'armGroupLabels': ['Infants drink formula added with LGG']}, {'name': 'Infants drink casein hydrolysate without LGG', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infants drink extensively hydrolysed casein formula without added LGG', 'armGroupLabels': ['Infants drink casein hydrolysate without LGG']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Central Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turku University Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Academy of Finland', 'class': 'OTHER'}, {'name': 'Mead Johnson Nutrition', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Prof. Erika Isolauri', 'oldOrganization': 'University of Turku'}}}}