Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2025-12-28 @ 7:19 AM
Study NCT ID:
NCT01505361
Status:
UNKNOWN
Last Update Posted:
2012-01-12
First Post:
2012-01-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of a Probiotic Strain to Prevent Mastitis and to Eradicate GBS Colonization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2015-07-29', 'releaseDate': '2015-07-02'}], 'estimatedResultsFirstSubmitDate': '2015-07-02'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008413', 'term': 'Mastitis'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005079', 'term': 'Excipients'}], 'ancestors': [{'id': 'D014677', 'term': 'Pharmaceutical Vehicles'}, {'id': 'D010592', 'term': 'Pharmaceutic Aids'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-01-11', 'studyFirstSubmitDate': '2012-01-04', 'studyFirstSubmitQcDate': '2012-01-05', 'lastUpdatePostDateStruct': {'date': '2012-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of clinical mastitis confirmed by microbiological cultures and somatic cell counts', 'timeFrame': 'Weekly during the first 6 months after birth'}], 'secondaryOutcomes': [{'measure': 'Evidence of eradication og GBS colonization as confirmed by microbiological analysis of vaginal exudate and rectal swab', 'timeFrame': 'At weeks 30, 35, 40 of pregnancy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['probiotic', 'Lactobacillus salivarius', 'mastitis', 'prevention', 'group B streptococci', 'intrapartum prophylaxis'], 'conditions': ['Mastitis']}, 'referencesModule': {'references': [{'pmid': '20455694', 'type': 'BACKGROUND', 'citation': 'Arroyo R, Martin V, Maldonado A, Jimenez E, Fernandez L, Rodriguez JM. Treatment of infectious mastitis during lactation: antibiotics versus oral administration of Lactobacilli isolated from breast milk. Clin Infect Dis. 2010 Jun 15;50(12):1551-8. doi: 10.1086/652763.'}, {'pmid': '18539795', 'type': 'BACKGROUND', 'citation': 'Jimenez E, Fernandez L, Maldonado A, Martin R, Olivares M, Xaus J, Rodriguez JM. Oral administration of Lactobacillus strains isolated from breast milk as an alternative for the treatment of infectious mastitis during lactation. Appl Environ Microbiol. 2008 Aug;74(15):4650-5. doi: 10.1128/AEM.02599-07. Epub 2008 Jun 6.'}, {'pmid': '32987448', 'type': 'DERIVED', 'citation': 'Crepinsek MA, Taylor EA, Michener K, Stewart F. Interventions for preventing mastitis after childbirth. Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.'}, {'pmid': '26611780', 'type': 'DERIVED', 'citation': 'Fernandez L, Cardenas N, Arroyo R, Manzano S, Jimenez E, Martin V, Rodriguez JM. Prevention of Infectious Mastitis by Oral Administration of Lactobacillus salivarius PS2 During Late Pregnancy. Clin Infect Dis. 2016 Mar 1;62(5):568-573. doi: 10.1093/cid/civ974. Epub 2015 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'In previous studies, the investigators have seen that carefully-selected Lactobacillus strains are a good alternative to antibiotics for the treatment of lactational mastitis. The objective of this new study is to check if they can also have a preventive role when administered to women with a history of mastitis with one or more previous infants. Since the investigators have also realized that peripartum antibiotherapy (mainly GBS-targeting intrapartum prophylaxis)is a predisposing factor for mastitis (because of the selection of resistant bacteria), the investigators would also like to test if administration of the strains to GBS-colonized pregnant women may lead to GBS eradication. Therefore, a mastitis-predisposing factor would de avoid.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Normal pregnancy\n* Healthy women\n* Lactational mastitis in, at least, a previous lactation period\n* No symptomatic vaginal infections\n\nExclusion Criteria:\n\n* Any kind of health problems related to pregnancy\n* Symptomatic vaginal infections\n* Allergy to cow's milk protein\n* Intolerance to lactose\n* Antibiotic treatment"}, 'identificationModule': {'nctId': 'NCT01505361', 'acronym': 'PROBIOPREG', 'briefTitle': 'Study of a Probiotic Strain to Prevent Mastitis and to Eradicate GBS Colonization', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Oral Administration of a Probiotic Strain to Pregnant Women: Effects on the Prevention of Lactational Mastitis and on the Eradication of GBS Colonization', 'orgStudyIdInfo': {'id': 'PROBIOPREG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'description': 'Pregnant women at 30 week of pregnancy(n=50) receiving Lactobacillus salivarius PS2(9 log per day, until birth)', 'interventionNames': ['Biological: Lactobacillus salivarius PS2']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Pregnant women at 30 week of pregnancy(n=50) receiving the excipient (once a day, until birth)', 'interventionNames': ['Biological: Excipient (milk powder)']}], 'interventions': [{'name': 'Lactobacillus salivarius PS2', 'type': 'BIOLOGICAL', 'description': '9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth', 'armGroupLabels': ['Probiotic']}, {'name': 'Excipient (milk powder)', 'type': 'BIOLOGICAL', 'description': '100 mg/once a day from 30 week of pregnancy until birth', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Juan M Rodriguez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Leonides Fernández, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Public Primary Health Care Centers network', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Juan M Rodríguez, PhD', 'role': 'CONTACT', 'email': 'jmrodrig@vet.ucm.es', 'phone': '34913943837'}], 'overallOfficials': [{'name': 'Juan M Rodriguez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Complutense University of Madrid, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, PhD', 'investigatorFullName': 'Juan M. Rodríguez', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2015-07-02', 'type': 'RELEASE'}, {'date': '2015-07-29', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Juan M. Rodríguez, Professor, PhD, Universidad Complutense de Madrid'}}}}