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Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase (ProBone16)

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ClinicalTrials.gov Identifier: NCT02722980
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Probi AB

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteopenia Dietary Supplement: Placebo Dietary Supplement: : Probiotic capsules Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study Aiming to Evaluate the Efficacy on BMD and Safety of a Probiotic Product in a Population of Healthy Women in Early Post-menopausal Phase, During an Intervention Period of 12 Months
Study Start Date : April 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menopause

Arm Intervention/treatment
Placebo Comparator: Placebo
Capsules
Dietary Supplement: Placebo
The intervention consists of capsules containing placebo.

Active Comparator: Active
Capsules.
Dietary Supplement: : Probiotic capsules
The intervention consists of capsules containing probiotics.




Primary Outcome Measures :
  1. Change in BMD at lumbar spine following an intervention period of 12 months and measured by DXA. [ Time Frame: Change in BMD from baseline to 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For inclusion in the study, subjects must fulfil the following criteria:

  1. Willing and able to give written informed consent for participation in the study.
  2. Healthy women in early post-menopausal phase (at least two [2] years but a maximum of 12 years since the last menstruation and at least one [1] year since the last intake of hormone replacement therapy).
  3. BMI ≥ 18 and ≤ 30 at screening.
  4. BMD T-score in the lumbar spine (L1-L4) > -2.5, as measured by DXA.
  5. Commitment not to use any products that may influence the study outcome in the opinion of the Investigator.
  6. Ability to understand and comply with the requirements of the study, as judged by the Investigator.

Exclusion Criteria:

Subjects must not enter the study if any of the following exclusion criteria are fulfilled:

  1. Relevant history of >1 previous fracture after 50 years of age, as judged by the Investigator.
  2. T-score ≤ - 2.5, in the total hip or lumbar spine (L1-L4). These subjects should be forwarded to a GP for further investigation.
  3. History of metabolic bone disease.
  4. Unstable weight (± five [5] kg) during the last six (6) months.
  5. History of hyperthyroidism or unstable hypothyroidism.
  6. Diagnosed with disease causing secondary osteoporosis within the last year, including primary hyperparathyroidism, chronic obstructive pulmonary disease, inflammatory bowel disease (IBD), celiac disease or diabetes.
  7. Known history of rheumatoid arthritis, clinically significant kidney or heart disease, as judged by the Investigator.
  8. Gastric bypass surgery performed.
  9. History of immunodeficiency or immunosuppressive treatment.
  10. Chronic or acute diarrheal disease.
  11. Recently diagnosed malignancy (within the last five [5] years).
  12. Use of products containing probiotic bacteria (more than once per week) within four (4) weeks prior to baseline.
  13. Per-oral use of corticosteroids.
  14. Use of calcium and/or vitamin D supplements within one (1) month prior to baseline.
  15. Use of any anti-resorptive therapy, including e.g. systemic hormone replacement therapy, bisphosphonates (currently or during last 12 months)
  16. Use of any bone-formation stimulating therapy (currently or during the last 12 months).
  17. Use of antibiotics during the last two (2) months.
  18. Frequent user of antibiotics (>2 courses during the last 12 months) due to inter-current infection episodes.
  19. Smoking or use of nicotine-containing products (currently or during the last six [6] months).
  20. History of alcohol abuse, or excessive intake of alcohol, as judged by the Investigator.
  21. Consumption of alcohol within 24 hours prior to the Baseline Visit.
  22. Participation in any other clinical interventional study during the last three (3) months.
  23. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
  24. Known hypersensitivity to any of the ingredients in the IP or the placebo (maltodextrin, silicon dioxide, capsule [hypromellose, water] ± bacterial culture).
  25. Blood or plasma donation within three (3) months prior to baseline.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722980


Locations
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Sweden
Gothenburg, Sweden
Uppsala, Sweden
Sponsors and Collaborators
Probi AB
Investigators
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Principal Investigator: Dan Curiac Gothenburg

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Responsible Party: Probi AB
ClinicalTrials.gov Identifier: NCT02722980     History of Changes
Other Study ID Numbers: ProBone16
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases