Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT03518268
Status:
UNKNOWN
Last Update Posted:
2019-01-17
First Post:
2018-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Vivomixx for Prevention of Bone Loss in Women With Breast Cancer Treated With an Aromatase Inhibitor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-16', 'studyFirstSubmitDate': '2018-04-25', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collagen type 1 cross-linked C-telopeptide (CTX)', 'timeFrame': '3-6 months', 'description': 'Change in percent in CTX in serum compared to placebo'}, {'measure': 'Serum type 1 procollagen (N-terminal) P1NP', 'timeFrame': '3-6 months', 'description': 'Change in percent in serum in P1NP compared to placebo'}], 'secondaryOutcomes': [{'measure': 'Alkaline phosphatase/ bone specific alkaline phosphatase', 'timeFrame': '3-6 months', 'description': 'Change in percent in alkaline phosphatase/ bone specific alkaline phosphatase in serum compared to placebo'}, {'measure': 'Osteocalcin', 'timeFrame': '3-6 months', 'description': 'Change in percent in osteocalcin in serum compared to placebo'}, {'measure': 'Sclerostin', 'timeFrame': '3-6 months', 'description': 'Change in percent in sclerostin in serum compared to placebo'}, {'measure': 'Tumor-necrosis factor-alpha', 'timeFrame': '3-6 months', 'description': 'Change in percent in tumor-necrosis factor-alpha in serum compared to placebo'}, {'measure': 'Interleukin-17', 'timeFrame': '3-6 months', 'description': 'Change in percent in interleukin-17 in serum compared to placebo'}, {'measure': 'Receptor activator of nuclear factor kappa B ligand (RANK-ligand)', 'timeFrame': '3-6 months', 'description': 'Change in percent in RANK-ligand in serum compared to placebo'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['probiotics', 'aromatase inhibitors', 'bone mass', 'postmenopausal'], 'conditions': ['Breast Cancer', 'Osteoporosis, Osteopenia']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of the probiotic food supplement Vivomixx in the prevention of bone loss occurring in post menopausal women with breast cancer treated with an aromatase inhibitor. Half of the participants will receive Vivomixx while the other half will receive a placebo. The primary endpoint is to assess changes of bone turnover markers during the period of 6 months.', 'detailedDescription': 'Aromatase inhibitors function to reduce estrogen levels. They are considered first-line treatment for postmenopausal women with estrogen receptor-positive breast cancer. Estrogen depletion leads to significant loss of bone mineral density and an increased fracture risk. One contributing mechanism to "estrogen deficiency associated bone loss" is the increase in systemic and local gut inflammatory responses upon estrogen deficiency. Probiotics have been shown to decrease inflammatory cytokine formation in both the systemic circulation and gut.\n\nVivomixx is a high potency probiotic medical food designated for the dietary management of inflammatory gut conditions in adults and children and is currently being studied in clinical trials in a wide variety of inflammatory conditions such as asthma and diabetes. In preclinical studies Vivomixx has been shown to protect from estrogen deficient bone loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Age≥ 35 years\n2. Breast cancer stages 1-3 (non metastatic)\n3. Under treatment with aromatase inhibitors\n4. In menopausal status for ≤10y\n5. Estrogen receptor positive tumor\n6. CTX ≥300 pg/ml\n\nExclusion criteria\n\n1. Distant metastases\n2. Additional active primary malignancy\n3. Metabolic bone disease (primary hyperparathyroidism, hyperthyroidism, paget, osteomalacia etc)\n4. Glucocorticoid treatment (chronic or high dose \\>7.5 mg in the last three months)\n5. Bisphosphonate treatment for more than 3 months in the last 2 years\n6. Bone densitometry (DXA) T-Score \\<-2 unless not a candidate for antiresorptive therapy (unwilling/unable to take treatment)\n7. Lactose intolerant subjects'}, 'identificationModule': {'nctId': 'NCT03518268', 'briefTitle': 'Vivomixx for Prevention of Bone Loss in Women With Breast Cancer Treated With an Aromatase Inhibitor', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'The Efficacy of the Probiotic Supplement Vivomixx on Prevention of Bone Loss in Early Menopausal Women With Breast Cancer Treated With an Aromatase Inhibitor', 'orgStudyIdInfo': {'id': '0124-18-TLV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dietary supplement Vivomixx', 'description': 'Vivomixx sachets contains a mixture of 450 billion viable lyophilized bacteria from 8 strains: Lactobacillus paracasei DSM 24733, Lactobacillus plantarum DSM 24730, Lactobacillus acidophilus DSM 24735, Lactobacillus delbrueckii subspecies bulgaricus DSM 24734, Bifidobacterium longum DSM 3 24736, Bifidobacterium infantis DSM 24737, Bifidobacterium breve DSM 24732, and Streptococcus thermophilus DSM 24731', 'interventionNames': ['Drug: Vivomixx']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The placebo sachets contain the inactive ingredients maltose and silicon dioxides', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vivomixx', 'type': 'DRUG', 'description': 'The intervention consists of 2 sachets a day containing the probiotic Vivomixx, for 6 months', 'armGroupLabels': ['Dietary supplement Vivomixx']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'The intervention consists of 2 sachets a day of placebo, for 6 months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sigal Shaklai, M.D, Ph.D', 'role': 'CONTACT', 'email': 'Sigal.shaklai@gmail.com', 'phone': '+972-3-6973732'}, {'name': 'Vanessa Rouach, M.D', 'role': 'CONTACT', 'email': 'vanessar@tlvmc.gov.il', 'phone': '+972-3-6973732'}], 'overallOfficials': [{'name': 'Naftali Stern, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tel-Aviv Sourasky Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Perrigo Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director General for R&D', 'investigatorFullName': 'michal roll', 'investigatorAffiliation': 'Tel-Aviv Sourasky Medical Center'}}}}