protocolSection identificationModule nctId: NCT06375668, orgStudyIdInfo id: CT/NB/140/2020/PR-MS, briefTitle: The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2022-03-15, primaryCompletionDateStruct date: 2024-01-15, completionDateStruct date: 2024-06-15, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Nordic Biotic Sp. z o.o., class: INDUSTRY, descriptionModule briefSummary: Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures. Osteoporosis develops as a result of genetic and environmental factors, with the patient's lifestyle playing an important role. Recent years saw an emergence of reports on the significance of the intestinal microbiota in the development of osteoporosis, thus new ways of modifying the composition and activity of microbiota have been sought, and the potential role of probiotics has been considered. Probiotics are defined as live microorganisms, which-when administered at appropriate doses-are beneficial to the host's health. Probiotics both modify the gut microbiota composition and directly affect the human body. Recently published clinical studies demonstrated that probiotics may facilitate osteoporosis treatment and prevention. The current randomized double-blind placebo-controlled study will assess the effect of a dietary intervention via oral supplementation of Lactobacillus plantarum and Lactobacillus paracasei in a population of Polish postmenopausal women on their bone mineral density assessed via bone densitometry-derived T-scores of the lumbar segment of the spine (L1-L4). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months., conditionsModule conditions: Osteoporosis, Postmenopausal, conditions: Bone Density, Low, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 170, type: ACTUAL, armsInterventionsModule interventions name: Probiotic, interventions name: Placebo, outcomesModule primaryOutcomes measure: The effect of intervention on bone mineral density, secondaryOutcomes measure: Changes in the level of calcium, secondaryOutcomes measure: Changes in the level of phosphorus, secondaryOutcomes measure: Changes in the level of alkaline phosphatase, secondaryOutcomes measure: Changes in the level of vitamin D, secondaryOutcomes measure: Changes in the level of C-reactive protein, secondaryOutcomes measure: Changes in Body Mass Index (BMI), secondaryOutcomes measure: Changes in type of stools, secondaryOutcomes measure: Changes in the number of bowel movements, secondaryOutcomes measure: Changes in severity of abdominal pain, secondaryOutcomes measure: Changes in severity of bloating, secondaryOutcomes measure: Occurrence of adverse events, secondaryOutcomes measure: Satisfaction with the intervention, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Private Specialist Practice, city: Bytom, zip: 41-902, country: Poland, geoPoint lat: 50.34802, lon: 18.93282, locations facility: Specialist Practice, city: Katowice, zip: 40-750, country: Poland, geoPoint lat: 50.25841, lon: 19.02754, locations facility: Clinical Research Center, city: Poznań, zip: 60-773, country: Poland, geoPoint lat: 52.40692, lon: 16.92993, hasResults: False