Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04922918
Status:
UNKNOWN
Last Update Posted:
2021-06-11
First Post:
2021-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ligilactobacillus Salivarius MP101 for Elderly in a Nursing Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-09', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Barthel index', 'timeFrame': '4 months', 'description': 'functional status score (daily activities)'}, {'measure': 'MNA score', 'timeFrame': '4 months', 'description': 'Nutritional status'}, {'measure': 'nasal and fecal immune profile', 'timeFrame': '4 months', 'description': '37-plex'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['covid-19', 'elderly', 'nursing home', 'probiotics'], 'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'The objective of this work was to investigate the effect of Ligilactobacillus salivarius MP101 on the functional (Barthel index), cognitive (GDS/FAST) and nutritional (MNA) status, and on the nasal and fecal inflammatory profiles of elderly living in a nursing home highly affected by COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '98 Years', 'minimumAge': '74 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Living in the nursing home\n* Informed consent obtained\n\nExclusion Criteria:\n\n* Absence of informed consent\n* Parenteral nutrition (exclusively)\n* Allergy to cow's milk protein"}, 'identificationModule': {'nctId': 'NCT04922918', 'acronym': 'PROBELDERLY', 'briefTitle': 'Ligilactobacillus Salivarius MP101 for Elderly in a Nursing Home', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Administration of Ligilactobacillus Salivarius MP101 in an Elderly Nursing Home During the COVID Pandemics', 'orgStudyIdInfo': {'id': 'CEIC 20/263-E_COVID'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic arm', 'description': 'Administration of Ligilactobacillus salivarius MP101 (\\>9 log10cfu, daily) for 4 months', 'interventionNames': ['Biological: Ligilactobacillus salivarius MP101']}], 'interventions': [{'name': 'Ligilactobacillus salivarius MP101', 'type': 'BIOLOGICAL', 'description': 'Administration of the strain through a fermented milk', 'armGroupLabels': ['Probiotic arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28411', 'city': 'Moralzarzal', 'state': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Isabel Malder, MD', 'role': 'CONTACT', 'email': 'cpmsantaisabel@cpmsantaisabel.com', 'phone': '34918421099'}], 'facility': 'Centro Para Mayores Santa Isabel, S.L.', 'geoPoint': {'lat': 40.67816, 'lon': -3.9707}}], 'centralContacts': [{'name': 'Juan Miguel Rodriguez, PhD', 'role': 'CONTACT', 'email': 'jmrodrig@ucm.es', 'phone': '34913943749'}, {'name': 'Leonides Fernández, PhD', 'role': 'CONTACT', 'email': 'leonides@ucm.es', 'phone': '34913943745'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head', 'investigatorFullName': 'Juan M. RodrÃguez', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}