Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase (ProBone16)
Primary Purpose
Osteopenia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Placebo
: Probiotic capsules
Sponsored by
About this trial
This is an interventional prevention trial for Osteopenia
Eligibility Criteria
Inclusion Criteria:
For inclusion in the study, subjects must fulfil the following criteria:
- Willing and able to give written informed consent for participation in the study.
- 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).
- BMI ≥ 18 and ≤ 30 at screening.
- BMD T-score in the lumbar spine (L1-L4) > -2.5, as measured by DXA.
- Commitment not to use any products that may influence the study outcome in the opinion of the Investigator.
- 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:
- Relevant history of >1 previous fracture after 50 years of age, as judged by the Investigator.
- T-score ≤ - 2.5, in the total hip or lumbar spine (L1-L4). These subjects should be forwarded to a GP for further investigation.
- History of metabolic bone disease.
- Unstable weight (± five [5] kg) during the last six (6) months.
- History of hyperthyroidism or unstable hypothyroidism.
- 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.
- Known history of rheumatoid arthritis, clinically significant kidney or heart disease, as judged by the Investigator.
- Gastric bypass surgery performed.
- History of immunodeficiency or immunosuppressive treatment.
- Chronic or acute diarrheal disease.
- Recently diagnosed malignancy (within the last five [5] years).
- Use of products containing probiotic bacteria (more than once per week) within four (4) weeks prior to baseline.
- Per-oral use of corticosteroids.
- Use of calcium and/or vitamin D supplements within one (1) month prior to baseline.
- Use of any anti-resorptive therapy, including e.g. systemic hormone replacement therapy, bisphosphonates (currently or during last 12 months)
- Use of any bone-formation stimulating therapy (currently or during the last 12 months).
- Use of antibiotics during the last two (2) months.
- Frequent user of antibiotics (>2 courses during the last 12 months) due to inter-current infection episodes.
- Smoking or use of nicotine-containing products (currently or during the last six [6] months).
- History of alcohol abuse, or excessive intake of alcohol, as judged by the Investigator.
- Consumption of alcohol within 24 hours prior to the Baseline Visit.
- Participation in any other clinical interventional study during the last three (3) months.
- 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
- Known hypersensitivity to any of the ingredients in the IP or the placebo (maltodextrin, silicon dioxide, capsule [hypromellose, water] ± bacterial culture).
- Blood or plasma donation within three (3) months prior to baseline.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Active
Arm Description
Capsules
Capsules.
Outcomes
Primary Outcome Measures
Change in BMD at lumbar spine following an intervention period of 12 months and measured by DXA.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02722980
Brief Title
Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase
Acronym
ProBone16
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 Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Probi AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
249 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Capsules
Arm Title
Active
Arm Type
Active Comparator
Arm Description
Capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
The intervention consists of capsules containing placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
: Probiotic capsules
Intervention Description
The intervention consists of capsules containing probiotics.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
For inclusion in the study, subjects must fulfil the following criteria:
Willing and able to give written informed consent for participation in the study.
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).
BMI ≥ 18 and ≤ 30 at screening.
BMD T-score in the lumbar spine (L1-L4) > -2.5, as measured by DXA.
Commitment not to use any products that may influence the study outcome in the opinion of the Investigator.
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:
Relevant history of >1 previous fracture after 50 years of age, as judged by the Investigator.
T-score ≤ - 2.5, in the total hip or lumbar spine (L1-L4). These subjects should be forwarded to a GP for further investigation.
History of metabolic bone disease.
Unstable weight (± five [5] kg) during the last six (6) months.
History of hyperthyroidism or unstable hypothyroidism.
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.
Known history of rheumatoid arthritis, clinically significant kidney or heart disease, as judged by the Investigator.
Gastric bypass surgery performed.
History of immunodeficiency or immunosuppressive treatment.
Chronic or acute diarrheal disease.
Recently diagnosed malignancy (within the last five [5] years).
Use of products containing probiotic bacteria (more than once per week) within four (4) weeks prior to baseline.
Per-oral use of corticosteroids.
Use of calcium and/or vitamin D supplements within one (1) month prior to baseline.
Use of any anti-resorptive therapy, including e.g. systemic hormone replacement therapy, bisphosphonates (currently or during last 12 months)
Use of any bone-formation stimulating therapy (currently or during the last 12 months).
Use of antibiotics during the last two (2) months.
Frequent user of antibiotics (>2 courses during the last 12 months) due to inter-current infection episodes.
Smoking or use of nicotine-containing products (currently or during the last six [6] months).
History of alcohol abuse, or excessive intake of alcohol, as judged by the Investigator.
Consumption of alcohol within 24 hours prior to the Baseline Visit.
Participation in any other clinical interventional study during the last three (3) months.
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
Known hypersensitivity to any of the ingredients in the IP or the placebo (maltodextrin, silicon dioxide, capsule [hypromellose, water] ± bacterial culture).
Blood or plasma donation within three (3) months prior to baseline.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Curiac
Organizational Affiliation
Gothenburg
Official's Role
Principal Investigator
Facility Information:
City
Gothenburg
Country
Sweden
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase
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