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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 16, 2016
First Posted Date  ICMJE March 30, 2016
Last Update Posted Date April 17, 2018
Study Start Date  ICMJE April 2016
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Osteopenia
Intervention  ICMJE
  • Dietary Supplement: Placebo
    The intervention consists of capsules containing placebo.
  • Dietary Supplement: : Probiotic capsules
    The intervention consists of capsules containing probiotics.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Capsules
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Active
    Capsules.
    Intervention: Dietary Supplement: : Probiotic capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2018)
249
Original Estimated Enrollment  ICMJE
 (submitted: March 29, 2016)
250
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 45 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02722980
Other Study ID Numbers  ICMJE ProBone16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Probi AB
Study Sponsor  ICMJE Probi AB
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dan Curiac Gothenburg
PRS Account Probi AB
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP