Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT03955159
Status:
UNKNOWN
Last Update Posted:
2020-01-27
First Post:
2019-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Probiotic Supplementation in Hypertensive Women on Menopause
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D064806', 'term': 'Dysbiosis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-08-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2019-04-15', 'studyFirstSubmitQcDate': '2019-05-16', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Autonomic Nervous System', 'timeFrame': '3 months', 'description': 'The data will be collected through the system of acquisition of pressure waves in a continuous and non-invasive way by the Finometer® system, through a cuffing installed in the middle finger, taking this signal to an analog-to-digital signal converter. The pulse pressure signal will be acquired at 1000 Hz, continuously and non-invasively, supine (10 minutes) in a quiet environment, with controlled temperature (± 23 ° C) and illumination.\n\nThe collected data will be saved in the software BeatsScope® and LabChart®, from which will be extracted the syistograms for analysis.\n\nThe autonomic nervous system will be assessed at baseline and after 3 months of intervention.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Arterial Hypertension', 'Menopause', 'Dysbiosis', 'Autonomic Nervous System Imbalance']}, 'descriptionModule': {'briefSummary': 'In postmenopausal women, cardiovascular risk is increased and the mechanisms involving imbalance of the Autonomic Nervous System should be extensively investigated. Recent data suggest a link with intestinal microbiota dysbiosis and probiotic supplementation could be a useful strategy for treating women with increased cardiovascular risk.', 'detailedDescription': 'After randomization, subjects will be included in their intervention group for a period of three months with initial and final evaluations.\n\nThe study will evaluate the effects and possible benefits of probiotic supplementation on the functioning of the Autonomic Nervous System and vascular changes in hypertension in menopausal women.\n\nThe intervention groups will be as follows:\n\n1. \\- Menopausal women with hypertension + Probiotic supplementation\n2. \\- Menopausal women with hypertension + Placebo supplementation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hypertensive\n* At least 1 year of menopause\n* Sedentary\n\nExclusion Criteria:\n\n* Smoker\n* Use of psychiatric medications\n* Cardiovascular events\n* Recent surgeries\n* Diabetic\n* Use of beta blockers'}, 'identificationModule': {'nctId': 'NCT03955159', 'briefTitle': 'Effects of Probiotic Supplementation in Hypertensive Women on Menopause', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiologia do Rio Grande do Sul'}, 'officialTitle': 'Effects of Probiotic Supplementation on Autonomic Nervous System Imbalance and Vascular Changes in Hypertensive Menopausal Women: RANDOMIZED CLINICAL TRIAL', 'orgStudyIdInfo': {'id': '549019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Probiotic supplementation', 'description': 'The probiotic is composed of the combination of Lactobacillus acidophilus and Bifidobacterium lactis, at the concentration of 109 CFU. This product presents no known hazards associated with its use. On the contrary, the use of this supplement is associated with a rebalancing of the intestinal microbiota with potential secondary benefits to the reconstitution of the intestinal symbiosis. Patients will receive 1 sachet of 1 gram per day and will be advised to dilute in 100 mL in water at room temperature for administration.', 'interventionNames': ['Dietary Supplement: Probiotic supplementation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo comparator', 'description': 'The placebo that will be used in the present study is maltodextrin, which is a food supplement based on carbohydrate powder.', 'interventionNames': ['Dietary Supplement: Probiotic supplementation']}], 'interventions': [{'name': 'Probiotic supplementation', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The probiotic is composed of the combination of Lactobacillus acidophilus and Bifidobacterium lactis, at the concentration of 109 CFU. This product presents no known hazards associated with its use. On the contrary, the use of this supplement is associated with a rebalancing of the intestinal microbiota with potential secondary benefits to the reconstitution of the intestinal symbiosis. Patients will receive 1 sachet of 1 gram per day and will be advised to dilute in 100 mL in water at room temperature for administration.', 'armGroupLabels': ['Experimental: Probiotic supplementation', 'Placebo comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90040371', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Liliana Fortini Cavalheiro Boll, Msc', 'role': 'CONTACT', 'email': 'liliana.lic@cardiologia.org.br', 'phone': '051 32303600', 'phoneExt': '4070'}], 'facility': 'Instituto de Cardiologia do Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Aline Dalmazo, Especialist', 'role': 'CONTACT', 'email': 'aline@dalmazo.com', 'phone': '+5551999774646'}, {'name': 'Maria Claudia Irigoyen, PhD', 'role': 'CONTACT', 'email': 'hipirigoyen@gmail.com', 'phone': '+555132303600'}], 'overallOfficials': [{'name': 'Maria Claudia Irigoyen, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto de Cardiologia - Fundação Universitária de Cardiologia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Cardiologia do Rio Grande do Sul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Aline Dalmazo', 'investigatorAffiliation': 'Instituto de Cardiologia do Rio Grande do Sul'}}}}