Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-01 @ 11:29 PM
Study NCT ID:
NCT03460392
Status:
UNKNOWN
Last Update Posted:
2018-03-09
First Post:
2018-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Human Microbiota in Healthy and Pathological Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000890', 'term': 'Anti-Infective Agents'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D003358', 'term': 'Cosmetics'}], 'ancestors': [{'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D006795', 'term': 'Household Products'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Stool samples;\n* bone and tissue biopsies;\n* tissues samples.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'targetDuration': '3 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-02', 'studyFirstSubmitDate': '2018-02-15', 'studyFirstSubmitQcDate': '2018-03-02', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bacterial abundances calculated by mean of Operational Taxonomic Unit (OTU) count', 'timeFrame': 'Up to 24 weeks', 'description': 'It is a measure of the bacterial amount'}], 'secondaryOutcomes': [{'measure': "Chao's indices estimated on the total OTU amount", 'timeFrame': 'Up to 24 weeks', 'description': 'It is a measure of bacterial diversity'}, {'measure': "Simpson's index (D) estimated on the total OTU amount", 'timeFrame': 'Up to 24 weeks', 'description': 'It is a measure of bacterial diversity'}, {'measure': "Shannon's index estimated on the total OTU amount", 'timeFrame': 'Up to 24 weeks', 'description': 'It is a measure of bacterial diversity'}, {'measure': "The OTU abundances will be used to calculate an adjacency matrix based on the Spearman's correlation coefficient (rs) among different bacterial genus", 'timeFrame': 'up to 24 weeks', 'description': 'It is a measure of strength of linear association between different bacterial genera'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Human microbiota'], 'conditions': ['Microbial Colonization']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to characterize the bacterial composition (microbiota) colonizing to the human body in different physio - pathological conditions (lifestyle, motor activity, surgical operations, probiotic and prebiotic consumption, antibiotic therapies, chemotherapeutic therapies), nervous and musculoskeletal diseases, gastrointestinal and metabolic disorders , oral and vaginal diseases, etc.). In particular, they will be investigate:\n\n* the changes in the bacterial abundance\n* the potential microbial interactions with the human host\n* the microbial networks describing on the bacterial interactions within a specific composition of the human microbiota', 'detailedDescription': 'The main objective of this study is to deepen the knowledge about the bacterial communities associated to the human organism. In particular, the present study aims to evaluate how the microbiota (intestinal, cutaneous, vaginal, nasal, bronchial, breast milk, salivary, oral, etc.) is subject to quantitative and qualitative changes consequently to different events involving the human host. The project trys to highlight which microorganisms may be involved in the onset or progression of certain pathological condition, as well as to identify which bacterial genera can be more subject to variations due to specific non-pathological events.\n\nSecondary objectives of this study are:\n\n* To define a "healthy microbiome", that is to understand which are the main bacteria that commonly compose the human microbiome in physiological conditions, differentiating it from that present in certain pathological conditions.\n* To characterize the physiological effects that bacterial changes of the human microbiota have on the host.\n* To evaluate whether the use of probiotics, prebiotics, dietary and nutritional factors, cosmetics, and oral, nasal, vaginal, or pharmacological therapies of any kind can influence the microbial network of the human microbiota associated to different body districts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'For each cohoort 15 healthy subjects will be enrolled (controls), for a total of 90 subjects.\n\nThe study involves the recruitment of 180 subjects (90 pathological and 90 healthy and recruited', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects suffering from neurological/behavioral diseases;\n* subjects suffering of bone diseases;\n* subjects affected of dysmetabolic / or endocrine disorders;\n* subjects with physical activities at a competitive level;\n* subjects affected of gastrointestinal disorders;\n* subjects with prolonged antibiotic therapies and undergoing surgery\n\nExclusion Criteria:\n\n* no use of probiotics in the month prior the sampling;\n* no use of antibiotics in the month prior the sampling;\n* no consumption of yogurt in the month prior the sampling;'}, 'identificationModule': {'nctId': 'NCT03460392', 'acronym': 'MicroSP', 'briefTitle': 'Study of Human Microbiota in Healthy and Pathological Conditions', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Study of Human Microbiota in Healthy and Pathological Conditions', 'orgStudyIdInfo': {'id': 'MiscoSP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neurological and behavioral disorders', 'description': 'Subjects with neurological or behavioral disorders such as Tourette syndrome are enrolled.', 'interventionNames': ['Drug: Antibiotic therapy']}, {'label': 'Subjects affected by bone diseases', 'description': 'Subjects affected by bone diseases such as infective osteomyelitis or osteoporosis are enrolled.', 'interventionNames': ['Drug: Antibiotic therapy']}, {'label': 'Dysmetabolic and/or endocrine disorders', 'description': 'Patients with endocrine disorders, such as thyroid disfunctions, or with metabolic disorders, including diabetes mellitus,are enrolled.'}, {'label': 'Subjects performing agonistic activity', 'description': 'Subjects performing physical activity at agonistic level are enrolled.'}, {'label': 'Gastroenteric disorders', 'description': 'Subjects affected by gastric and/or enteric disorders are enrolled.'}, {'label': 'Prolonged antibiotic therapy', 'description': 'Patients subjected to prolonged antibiotic therapies and undergone a variety of surgical procedures are enrolled.', 'interventionNames': ['Drug: Antibiotic therapy']}, {'label': 'Healthy subjects', 'description': 'Subjects without any known ongoing disease are enrolled.'}], 'interventions': [{'name': 'Antibiotic therapy', 'type': 'DRUG', 'otherNames': ['Probiotics, dietary factors, cosmetics and adjuvants'], 'description': 'To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time;', 'armGroupLabels': ['Neurological and behavioral disorders', 'Prolonged antibiotic therapy', 'Subjects affected by bone diseases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20161', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'IRCCS Istituto Ortopedico Galeazzi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'overallOfficials': [{'name': 'Lorenzo Drago, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Galeazzi Orthopedic Institute, Milan, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}