N/A
N=64
Lactobacillus Acidophilus and Postmenopausal Women
Bone Loss · Post Menopausal Osteoporosis · Mineralization
Bottom Line
View on ClinicalTrials.gov: NCT05332626 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Calcium — 1.88; 2.04 mmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Probiotic group (Dietary_supplement); Placebo group (Dietary_supplement)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Poznan University of Life Sciences
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Calcium |
1.88; 2.04 | — |
| PRIMARY DXA |
1.12; 1.15 | — |
| SECONDARY Body Mass |
72.22; 73.88 | — |
| SECONDARY Calcium Intake |
1,115.81; 894.72 | — |
| SECONDARY Biomarkers of Bone Turnover: CTX |
5.67; 5.11 | — |
| SECONDARY Biomarkers of Bone Turnover: TRAP5b |
26.09; 21.13 | — |
| SECONDARY Biomarkers of Bone Resorption: BSAP |
10.90; 11.38 | — |
| SECONDARY Biomarkers of Bone Resorption: PINP |
2.64; 2.66 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT05332626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.