ClinicalTrials.gg
CompletedNCT05332626LaBonUpdated Jan 8, 2026Results posted

Lactobacillus Acidophilus and Postmenopausal Women

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.

Primary conditionOsteoporosis, PostmenopausalRegistry: Bone Diseases, MetabolicReclassifiedWhy we changed it
Registry
Bone Diseases, Metabolic — the first condition term the registry derived for this study.
ClinicalTrials.gg
Osteoporosis, Postmenopausal
Why
  1. The study's listed conditions name Osteoporosis, Postmenopausal, a narrower term within Bone Diseases, Metabolic.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Poznan University of Life Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Bone Loss
  • Post Menopausal Osteoporosis
  • Mineralization

Keywords

  • Probiotic
  • Lactobacillus acidophilus
  • Calcium status
  • Bone resorption
  • Bone formation
  • Post Menopausal Osteoporosis
03

In context

Osteoporosis, Postmenopausal Reclassified

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 →

Lead sponsor

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 →

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Women aged 45 to 70 years old with more than one year since last menstruation;
  2. (BMI): 27.0 kg/m2 to 34.9 kg/m2;
  3. All female participants who accepted bone densitometry measurement

Exclusion criteria

Exclusion Criteria:

  1. The secondary form of obesity, the pharmacological treatment for obesity (in the three months before the study), history of bariatric surgery;
  2. Other gastrointestinal disorders, especially: inflammatory bowel diseases, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of irritable bowel syndrome;
  3. Pharmacotherapy of lipid disorders or hypertension in the three months before enrollment
  4. acute inflammatory process (elevated hsCRP)
  5. Abnormal kidney function ( \<60mL/min/1,73m2);
  6. Participation in a body mass management study;
  7. The use of drugs known to modify body mass or food intake;
  8. Hormone replacement therapy;
  9. 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;
  10. History of use of any dietary supplements, including calcium, in the three months before the study;
  11. History of intake of antibiotics, probiotics, prebiotics (and synbiotics) within three months before the study;
  12. Type 2 diabetes - - requiring the introduction and/or change of pharmacological treatment in the 2 years before the trial or during intervention;
  13. Dyslipidemia - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
  14. Hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
  15. Another chronic pharmacotherapy: nonsteroidal anti-inflammatory drugs, proton pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
  16. Diseases requiring nutritional requirement and chronic supplementation;
  17. Alcohol (>20g/d), nicotine or drug abuse;
  18. Mental disorders, including eating disorders;
  19. Cancer, diseases;
  20. 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.
Terms in these criteria, in plain language(4)

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.

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Probiotic group

    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

  • Placebo comparator
    Placebo group

    The placebo group will receive a capsule that consists of the excipient (maize starch and maltodextrins) for 12 weeks

    Dietary Supplement: Placebo group

Interventions

  • Dietary supplementProbiotic 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)

  • Dietary supplementPlacebo group

    The group is assigned on the treatment of postmenopause osteoporosis women without probiotic intervention (30 people)

06

What researchers measure

Primary outcomes

  1. Calcium

    measure the calcium concentration in serum and hair

    Time frame: 2 years

  2. DXA

    bone densitometry analysis

    Time frame: 2 years

Secondary outcomes

  1. Body Mass

    measure body mass in kilograms

    Time frame: 2 years

  2. Calcium Intake

    assessing calcium intake with the questionnaire

    Time frame: 2 years

  3. Biomarkers of Bone Turnover: CTX

    measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum

    Time frame: 2 years

  4. Biomarkers of Bone Turnover: TRAP5b

    measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum

    Time frame: 2 years

  5. Biomarkers of Bone Resorption: BSAP

    measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum

    Time frame: 2 years

  6. Biomarkers of Bone Resorption: PINP

    measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum

    Time frame: 2 years

07

Results

Posted Jan 8, 2026

Participant flow

Participant flow — Overall Study
MilestoneProbiotic GroupPlacebo Group
Started3232
Completed3025
Not completed27

Outcome measures

PrimaryCalcium

measure the calcium concentration in serum and hair

Time frame:
2 years
Reported as:
Mean · mmol/L
Calcium
mmol/LProbiotic GroupPlacebo Group
Calcium1.88 ± 0.442.04 ± 0.09
PrimaryDXA

bone densitometry analysis

Time frame:
2 years
Reported as:
Mean · g/cm2
DXA
g/cm2Probiotic GroupPlacebo Group
DXA1.12 ± 0.121.15 ± 0.11
SecondaryBody Mass

measure body mass in kilograms

Time frame:
2 years
Reported as:
Mean · kg
Body Mass
kgProbiotics GroupPlacebo Group
Body Mass72.22 ± 15.2173.88 ± 13.45
SecondaryCalcium Intake

assessing calcium intake with the questionnaire

Time frame:
2 years
Reported as:
Mean · gram
Calcium Intake
gramProbiotics GroupPlacebo Group
Calcium Intake1,115.81 ± 529.76894.72 ± 381.84
SecondaryBiomarkers of Bone Turnover: CTX

measure the concentration of C-terminal telopeptide of type I collagen (CTX) in serum

Time frame:
2 years
Reported as:
Mean · pg/ml
Biomarkers of Bone Turnover: CTX
pg/mlProbiotics GroupPlacebo Group
Biomarkers of Bone Turnover: CTX5.67 ± 0.525.11 ± 0.52
SecondaryBiomarkers of Bone Turnover: TRAP5b

measure the concentration of tatrate-resistant acid phosphatase isoform-5b (TRAP5b) in serum

Time frame:
2 years
Reported as:
Mean · ng/ml
Biomarkers of Bone Turnover: TRAP5b
ng/mlProbiotics GroupPlacebo Group
Biomarkers of Bone Turnover: TRAP5b26.09 ± 9.3121.13 ± 6.33
SecondaryBiomarkers of Bone Resorption: BSAP

measure the concentration of bone-specific alkaline phosphatase (BSAP) in serum

Time frame:
2 years
Reported as:
Mean · ng/ml
Biomarkers of Bone Resorption: BSAP
ng/mlProbiotics GroupPlacebo Group
Biomarkers of Bone Resorption: BSAP10.90 ± 1.5611.38 ± 1.96
SecondaryBiomarkers of Bone Resorption: PINP

measure the concentration of N-terminal propeptide of type I procollagen (PINP) in serum

Time frame:
2 years
Reported as:
Mean · ng/ml
Biomarkers of Bone Resorption: PINP
ng/mlProbiotics GroupPlacebo Group
Biomarkers of Bone Resorption: PINP2.64 ± 0.522.66 ± 0.52

Adverse events

Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Probiotic Group0/30 (0%)0/30 (0%)0/30 (0%)
Placebo Group0/25 (0%)0/25 (0%)0/25 (0%)

Baseline characteristics

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
Age, Categorical(Participants)Probiotic GroupPlacebo GroupTotal
<=18 years000
Between 18 and 65 years000
>=65 years323264
Age, Continuous
Age, Continuous(years)Probiotic GroupPlacebo GroupTotal
Mean59.6 ± 6.556.5 ± 5.858.1 ± 6.3
Sex: Female, Male
Sex: Female, Male(Participants)Probiotic GroupPlacebo GroupTotal
Female323264
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Probiotic GroupPlacebo GroupTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Probiotic GroupPlacebo GroupTotal
Poland323264
08

Study locations

1 site
  • Poznan University of Life Sciences
    Poznan, Greater Poland Voivodeship 60-624, Poland
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05332626
Lead sponsor
Poznan University of Life Sciences
Responsible party
Iskandar Harahap (Principal Investigator, Poznan University of Life Sciences) — Principal investigator
First posted
Apr 18, 2022
Start date
Feb 1, 2022
Primary completion
Jul 1, 2024
Completion
Jul 1, 2024
Results posted
Jan 8, 2026
Last update
Jan 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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