OsteopeniaProBone16NCT02722980
Efficacy of a Probiotic Product on Bone Mineral Density (BMD) in Healthy Women in Early Post-menopausal Phase
A study testing : Probiotic capsules in people with Osteopenia, run by Probi AB at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- : Probiotic capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 249 participants
- Where
- 2 sitesSweden
- Study dates
- Apr 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- Conditions
- Osteopenia
- Being tested
- Placebo, : Probiotic capsules
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
The intervention consists of capsules containing placebo.
: Probiotic capsulesDietary supplement
The intervention consists of capsules containing probiotics.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Capsules Receives: Dietary Supplement: Placebo |
| Active | Active comparator | Capsules. Receives: Dietary Supplement: : Probiotic capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BMD at lumbar spine following an intervention period of 12 months and measured by DXA.
Measured: Change in BMD from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- Probi AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Curiac, Principal investigator, Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722980
- Sponsor's protocol ID
- ProBone16
- Acronym
- ProBone16
- Status last verified
- Apr 2018
- First submitted
- 16 Mar 2016
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jansson PA, Curiac D, Lazou Ahren I, Hansson F, Martinsson Niskanen T, Sjogren K, Ohlsson C. Probiotic treatment using a mix of three Lactobacillus strains for lumbar spine bone loss in postmenopausal women: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet Rheumatol. 2019 Nov;1(3):e154-e162. doi: 10.1016/S2665-9913(19)30068-2. Epub 2019 Oct 23.
PubMed 38229392
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02722980
- Acronym / sponsor ID
- ProBone16 / ProBone16
- Conditions
- Osteopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- Probi ABIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboCapsules |
| Active | Active comparator | Dietary Supplement: : Probiotic capsulesCapsules. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboThe intervention consists of capsules containing placebo. | Dietary supplement | Placebo |
| : Probiotic capsulesThe intervention consists of capsules containing probiotics. | Dietary supplement | Active |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 38229392Jansson PA, Curiac D, Lazou Ahren I, Hansson F, Martinsson Niskanen T, Sjogren K, Ohlsson C. Probiotic treatment using a mix of three Lactobacillus strains for lumbar spine bone loss in postmenopausal women: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet Rheumatol. 2019 Nov;1(3):e154-e162. doi: 10.1016/S2665-9913(19)30068-2. Epub 2019 Oct 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dan Curiac principal investigator
Gothenburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing : Probiotic capsules in people with Osteopenia, run by Probi AB at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.