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

Probi AB0 sites249 target enrollmentApril 2016

ConditionsOsteopenia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Osteopenia
Sponsor: Probi AB
Enrollment: 249
Primary Endpoint: Change in BMD at lumbar spine following an intervention period of 12 months and measured by DXA.
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

January 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Probi AB

Responsible Party

Sponsor

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.