Bone LossLaBonNCT05332626
Lactobacillus Acidophilus and Postmenopausal Women
A study testing Probiotic group in people with Bone Loss and Post Menopausal Osteoporosis, run by Poznan University of Life Sciences at 1 site in Poland.
Trial summary
This study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study. Read more about this study
- Who is it for?
- Ages 45 to 70 years, women only
- Conditions the study is for
- Bone Loss, Post Menopausal Osteoporosis, Mineralization
- What is being tested?
- Probiotic group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 45 to 70 years old with more than one year since last menstruation;
- Body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
- All female participants who accepted bone densitometry measurement
Who cannot join
- The secondary form of obesity, the pharmacological treatment for obesity (in the three months before the study), history of bariatric surgery;
- Other gastrointestinal disorders, especially: inflammatory bowel diseases, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of irritable bowel syndrome;
- Pharmacotherapy of lipid disorders or hypertension in the three months before enrollment
- Clinically significant acute inflammatory process (elevated hsCRP)
- Abnormal kidney function (GFR <60mL/min/1,73m2);
- Participation in a body mass management study;
Show all 20Show fewer
- The use of drugs known to modify body mass or food intake;
- Hormone replacement therapy;
- History of following alternative diets (diets with the altered amount of macronutrients, vegan or vegetarian diets, high-fiber diet, a diet with high quantities of fermented food (>400 g/day), diet fortified with prebiotics- and probiotics-functional food, elimination diets, low-calorie diets) within three months before the study;
- History of use of any dietary supplements, including calcium, in the three months before the study;
- History of intake of antibiotics, probiotics, prebiotics (and synbiotics) within three months before the study;
- Type 2 diabetes - - requiring the introduction and/or change of pharmacological treatment in the 2 years before the trial or during intervention;
- Dyslipidemia - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
- Hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
- Another chronic pharmacotherapy: nonsteroidal anti-inflammatory drugs, proton pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
- Diseases requiring nutritional requirement and chronic supplementation;
- Alcohol (>20g/d), nicotine or drug abuse;
- Mental disorders, including eating disorders;
- Cancer, autoimmune diseases;
- Any other condition that, in the opinion of the investigators, would make participation not in the best interest of the subject, or could prevent, limit, or confound the efficacy of the study any diseases, disorders, and therapies, which may influence on final results of the study or pose a risk for subjects health.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Life Sciences
Poznan, Greater Poland Voivodeship, 60-624
About this study
Official title: Can Lactobacillus Acidophilus Decrease the Risk of Postmenopausal in Women?
This study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study.
Read the detailed description
This study has three steps; namely, 1st step is to prepare the diet supplementation of probiotics and placebo. 2nd step is to perform the randomized, double-blind placebo-controlled clinical trial. 3rd step is to analyze the effects of L. acidophilus UALa-01™ in postmenopausal women.
- Conditions
- Bone Loss, Post Menopausal Osteoporosis, Mineralization
- Being tested
- Probiotic group, Placebo group
- Keywords
- Probiotic, Lactobacillus acidophilus, Calcium status, Bone resorption, Bone formation, Post Menopausal Osteoporosis
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, Postmenopausal, Calcinosis, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic groupDietary supplement
The probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people)
Placebo groupDietary supplement
The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Experimental | The probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10^9 CFU for 12 weeks Receives: Dietary Supplement: Probiotic group |
| Placebo group | Placebo comparator | The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks Receives: Dietary Supplement: Placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium
measure the calcium concentration in serum and hair
Measured: 2 years
DXA
bone densitometry analysis
Measured: 2 years
Secondary outcomes (6)
Body Mass
measure body mass in kilograms
Measured: 2 years
Calcium Intake
assessing calcium intake with the questionnaire
Measured: 2 years
Biomarkers of Bone Turnover: CTX
measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum
Measured: 2 years
Biomarkers of Bone Turnover: TRAP5b
measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum
Measured: 2 years
Biomarkers of Bone Resorption: BSAP
measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum
Measured: 2 years
Biomarkers of Bone Resorption: PINP
measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start1 Feb 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trail
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Life Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Responsible party
- Principal investigator, Iskandar Harahap, Poznan University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332626
- Sponsor's protocol ID
- 668/21
- Acronym
- LaBon
- Status last verified
- Dec 2025
- First submitted
- 23 Mar 2022
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Lactobacillus Acidophilus Decrease the Risk of Postmenopausal in Women?
- ClinicalTrials.gov ID
- NCT05332626
- Acronym / sponsor ID
- LaBon / 668/21
- Conditions
- Bone Loss, Post Menopausal Osteoporosis, Mineralization
- Keywords
- Probiotic, Lactobacillus acidophilus, Calcium status, Bone resorption, Bone formation, Post Menopausal Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Poznan University of Life SciencesUniversity, hospital or other
- Collaborators
- Poznan University of Medical Sciences
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Posted 8 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effect of Lactobacillus acidophilus supplementation on calcium status and bone densitometry in postmenopausal women in a randomized, double-blind placebo-controlled study.
Detailed description
This study has three steps; namely, 1st step is to prepare the diet supplementation of probiotics and placebo. 2nd step is to perform the randomized, double-blind placebo-controlled clinical trial. 3rd step is to analyze the effects of L. acidophilus UALa-01™ in postmenopausal women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized Controlled Trail
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Experimental | Dietary Supplement: Probiotic groupThe probiotic group will receive a supplement diet capsule consisting of Lactobacillus acidophilus UALa-01™ with a dose of 1x10^9 CFU for 12 weeks |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo groupThe placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women aged 45 to 70 years old with more than one year since last menstruation;
- Body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
- All female participants who accepted bone densitometry measurement
Key exclusion criteria (20 listed)
- The secondary form of obesity, the pharmacological treatment for obesity (in the three months before the study), history of bariatric surgery;
- Other gastrointestinal disorders, especially: inflammatory bowel diseases, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of irritable bowel syndrome;
- Pharmacotherapy of lipid disorders or hypertension in the three months before enrollment
- Clinically significant acute inflammatory process (elevated hsCRP)
- Abnormal kidney function (GFR <60mL/min/1,73m2);
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 |
|---|---|---|
| Probiotic groupThe probiotic gorup is focused on the treatment of postmenopause osteoporosis women with a capsule cointained 1x10^9 CFU of Lactobacillus acidophilus UALa-01™/day (30 people) | Dietary supplement | Probiotic group |
| Placebo groupThe group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people) | Dietary supplement | Placebo group |
Primary outcome
Calcium
Time frame: 2 years
measure the calcium concentration in serum and hair
DXA
Time frame: 2 years
bone densitometry analysis
6 secondary outcomes
Body Mass
Time frame: 2 years
Calcium Intake
Time frame: 2 years
Biomarkers of Bone Turnover: CTX
Time frame: 2 years
Biomarkers of Bone Turnover: TRAP5b
Time frame: 2 years
Biomarkers of Bone Resorption: BSAP
Time frame: 2 years
Biomarkers of Bone Resorption: PINP
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bone Loss
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
Active, not recruiting
AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone Density
Osteopenia
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic group in people with Bone Loss and Post Menopausal Osteoporosis, run by Poznan University of Life Sciences at 1 site in Poland.
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 3 inclusion and 20 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 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Calcium (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.