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The aim of the current study is to evaluate the efficacy of a probiotic product on bone mineral density (BMD) in healthy early post-menopausal women, compared to placebo. The primary endpoint is to assess changes of BMD at lumbar spine after an intervention period of 12 months. Changes in BMD at the femoral neck (hip) will also be measured as well as changes in bone turnover markers during the period of 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Capsules |
|
| Active | Active Comparator | Capsules. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | The intervention consists of capsules containing placebo. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BMD at lumbar spine following an intervention period of 12 months and measured by DXA. | Change in BMD from baseline to 12 months |
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Inclusion Criteria:
For inclusion in the study, subjects must fulfil the following criteria:
Exclusion Criteria:
Subjects must not enter the study if any of the following exclusion criteria are fulfilled:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Curiac | Gothenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gothenburg | Sweden | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38229392 | Derived | Jansson PA, Curiac D, Lazou Ahren I, Hansson F, Martinsson Niskanen T, Sjogren K, Ohlsson C. Probiotic treatment using a mix of three Lactobacillus strains for lumbar spine bone loss in postmenopausal women: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet Rheumatol. 2019 Nov;1(3):e154-e162. doi: 10.1016/S2665-9913(19)30068-2. Epub 2019 Oct 23. |
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| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| : Probiotic capsules |
| Dietary Supplement |
The intervention consists of capsules containing probiotics. |
|
| Uppsala |
| Sweden |
| D019602 |
| Food and Beverages |