An interventional study of Probiotic group and Placebo group in Bone Loss, Post Menopausal Osteoporosis and Mineralization, sponsored by Poznan University of Life Sciences. Completed at 1 site in Poland. Open to female participants aged 45 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Poznan University of Life Sciences · Not applicable, Interventional, and Treatment
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.
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.
334 studies on the registry are indexed under Osteoporosis, Postmenopausal; 28 are open to participants now.
This study's enrollment of 90 is below the median of 119 across 264 interventional studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal studies →Poznan University of Life Sciences is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Compared within Osteoporosis, Postmenopausal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Bone Diseases, Metabolic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Dietary Supplement: Probiotic group
The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks
Dietary Supplement: Placebo group
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)
The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)
Calcium
measure the calcium concentration in serum and hair
Time frame: 2 years
DXA
bone densitometry analysis
Time frame: 2 years
Body Mass
measure body mass in kilograms
Time frame: 2 years
Calcium Intake
assessing calcium intake with the questionnaire
Time frame: 2 years
Biomarkers of Bone Turnover: CTX
measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum
Time frame: 2 years
Biomarkers of Bone Turnover: TRAP5b
measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum
Time frame: 2 years
Biomarkers of Bone Resorption: BSAP
measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum
Time frame: 2 years
Biomarkers of Bone Resorption: PINP
measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum
Time frame: 2 years
| Milestone | Probiotic Group | Placebo Group |
|---|---|---|
| Started | 32 | 32 |
| Completed | 30 | 25 |
| Not completed | 2 | 7 |
measure the calcium concentration in serum and hair
| mmol/L | Probiotic Group | Placebo Group |
|---|---|---|
| Calcium | 1.88 ± 0.44 | 2.04 ± 0.09 |
bone densitometry analysis
| g/cm2 | Probiotic Group | Placebo Group |
|---|---|---|
| DXA | 1.12 ± 0.12 | 1.15 ± 0.11 |
measure body mass in kilograms
| kg | Probiotics Group | Placebo Group |
|---|---|---|
| Body Mass | 72.22 ± 15.21 | 73.88 ± 13.45 |
assessing calcium intake with the questionnaire
| gram | Probiotics Group | Placebo Group |
|---|---|---|
| Calcium Intake | 1,115.81 ± 529.76 | 894.72 ± 381.84 |
measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum
| pg/ml | Probiotics Group | Placebo Group |
|---|---|---|
| Biomarkers of Bone Turnover: CTX | 5.67 ± 0.52 | 5.11 ± 0.52 |
measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum
| ng/ml | Probiotics Group | Placebo Group |
|---|---|---|
| Biomarkers of Bone Turnover: TRAP5b | 26.09 ± 9.31 | 21.13 ± 6.33 |
measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum
| ng/ml | Probiotics Group | Placebo Group |
|---|---|---|
| Biomarkers of Bone Resorption: BSAP | 10.90 ± 1.56 | 11.38 ± 1.96 |
measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum
| ng/ml | Probiotics Group | Placebo Group |
|---|---|---|
| Biomarkers of Bone Resorption: PINP | 2.64 ± 0.52 | 2.66 ± 0.52 |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Probiotic Group | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Placebo Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
Postmenopausal women aged 45-70 with a BMI of 27.0-34.9 kg/m² were recruited, meeting criteria of amenorrhea for 12+ months. Exclusions included diabetes, secondary obesity, GI diseases, recent dietary supplements, pharmacotherapy for lipid issues, smoking, alcohol/drug abuse, or recent antibiotic use. Of 64 eligible participants, 55 completed the 12-week intervention, randomized in a double-blind design to probiotic or placebo groups.
| Age, Categorical(Participants) | Probiotic Group | Placebo Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 32 | 32 | 64 |
| Age, Continuous(years) | Probiotic Group | Placebo Group | Total |
|---|---|---|---|
| Mean | 59.6 ± 6.5 | 56.5 ± 5.8 | 58.1 ± 6.3 |
| Sex: Female, Male(Participants) | Probiotic Group | Placebo Group | Total |
|---|---|---|---|
| Female | 32 | 32 | 64 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Probiotic Group | Placebo Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Probiotic Group | Placebo Group | Total |
|---|---|---|---|
| Poland | 32 | 32 | 64 |
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
Osteoporosis, Postmenopausal →
Poznan University of Life Sciences