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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: : Probiotic capsules

• Study Type: Interventional
• Enrollment (Actual): 249
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
  • Uppsala, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Probi AB
• Investigators: Principal Investigator: Dan Curiac, Gothenburg

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: March 16, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): March 30, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 12, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: ProBone16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO