Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-01-06 @ 2:45 PM
Study NCT ID:
NCT05565651
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2022-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study of Intestinal Microbiota in Association With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064806', 'term': 'Dysbiosis'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 334}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-29', 'studyFirstSubmitDate': '2022-09-23', 'studyFirstSubmitQcDate': '2022-09-29', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome percentage Phyla', 'timeFrame': '2020-2022', 'description': 'Change in the percentage of Proteobacteria in type 2 diabetic patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microbiote', 'Dysbiosis'], 'conditions': ['Dysbiosis Symptoms Linked to Pathology']}, 'descriptionModule': {'briefSummary': 'The microbiota interacts with several human organs and influences the physiological process in the host. The predominant Phyla of species in the gut microbiota are Bacteroidetes (B) and Firmicutes (F), accounting for 60-80%, and Proteobacteria (P) and Actinobacteria (A) in minority. When some of the bacterial Phyla species are unbalanced, the pathological state of dysbiosis occurs. A laboratory index used for clinical analyzes is the F / B ratio \\<0.8, which characterizes an intestinal dysbiotic state.\n\nMany causes can affect the intestinal microbiota, thus altering it in a dysbiotic state, first of all the diet. In fact, dysbiosis can be characterized both by the severity with which it manifests itself and is also distinguished in putrefactive and fermentative dysbiosis.\n\nFurthermore, the variation in the "normal" percentages of the Phyla is also related to some pathological alterations.\n\nThe aim of this study will be to monitor the population and heterogeneity of the microbiota in the Italian population. Knowing the complex implications of dysbiosis and the extensive data on it, this study will want to detail the state of the gut microbiota in the previously indicated population, focusing attention on peculiar profiles that could reflect a pathogenic spectrum or metabolic disturbances.\n\nThe study aims to investigate the diffusion and state of the microbiota in the Italian territory and if it occurs in association with certain pathologies and / or diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '16 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '334 fecal samples from Lifebrain Cerba Healthcare Italian laboratory network were analyzed to perform a gut microbiota genetic test, accompanied by filling an attachment to provide a medical history useful for the interpretation of the results obtained and to provide a correct diagnosis using a specific test kit for the stool sample collection. The samples were collected from people aged between 2 and 87 years old.', 'genderDescription': 'Male and Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 16 and 80 years old,\n* Patients with completed questionnare\n* Dysbiosis symptoms\n\nExclusion Criteria:\n\n* Under 16 years old,\n* over 80 years old,\n* patients misidentified'}, 'identificationModule': {'nctId': 'NCT05565651', 'briefTitle': 'Retrospective Study of Intestinal Microbiota in Association With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'Retrospective Study for the Characterization of the Intestinal Microbiota in Association With Pathologies and Diet in the Italian Population', 'orgStudyIdInfo': {'id': '8/14/2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fecal microbiota analysis', 'type': 'OTHER', 'description': 'Data analysis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00012', 'city': 'Guidonia', 'state': 'Roma', 'country': 'Italy', 'facility': 'Lifebrain Cerba Healthcare laboratory network', 'geoPoint': {'lat': 41.99232, 'lon': 12.71876}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Palermo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'FRANCESCA DI GAUDIO', 'investigatorAffiliation': 'University of Palermo'}}}}