An interventional study of Probiotic and Placebo in Osteoporosis, Postmenopausal and Bone Density, Low, sponsored by Nordic Biotic Sp. z o.o.. Completed at 3 sites in Poland. Open to female participants. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Nordic Biotic Sp. z o.o. · Not applicable, Interventional, and Treatment
Osteoporosis is a systemic condition characterized by low bone mass and altered bone tissue microarchitecture, with the resulting greater bone fragility leading to fractures. Osteoporosis develops as a result of genetic and environmental factors, with the patient's lifestyle playing an important role. Recent years saw an emergence of reports on the significance of the intestinal microbiota in the development of osteoporosis, thus new ways of modifying the composition and activity of microbiota have been sought, and the potential role of probiotics has been considered. Probiotics are defined as live microorganisms, which-when administered at appropriate doses-are beneficial to the host's health. Probiotics both modify the gut microbiota composition and directly affect the human body. Recently published clinical studies demonstrated that probiotics may facilitate osteoporosis treatment and prevention. The current randomized double-blind placebo-controlled study will assess the effect of a dietary intervention via oral supplementation of Lactobacillus plantarum and Lactobacillus paracasei in a population of Polish postmenopausal women on their bone mineral density assessed via bone densitometry-derived T-scores of the lumbar segment of the spine (L1-L4). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months.
The main purpose of the study is to assess the effect of oral probiotic supplementation on bone mineral density in postmenopausal women. A total of 170 female subjects who meet all the inclusion criteria and none of the exclusion criteria are to be included and randomized to one of two arms (the probiotic arm or the placebo arm) at a ratio of 1:1.
The subjects who provide their written informed consent will receive oral probiotic formulation containing a mixture of two strains Lactobacillus plantarum and Lactobacillus paracasei or placebo. The probiotic formulation and placebo will be provided by Nordic Biotic Ltd. (the company will also ensure study drug blinding). Study subjects will take the provided probiotic formulation/placebo orally once daily for 12 months.
The study timeline spans 54 weeks and involves 13 visits, including:
All subjects included in the study will undergo:
At each visit, whether conducted at the doctor's office or remotely, subjects will be asked about their use of the study drug and any gastrointestinal symptoms (number of bowel movements, stool consistency, bloating, abdominal pain), and the use of any other medications (including antibiotics). Each time, the subjects will be also asked about any side effects. Stool consistency will be assessed with the Bristol Stool Form Scale, and abdominal pain, bloating, and nausea will be assessed with a 5-grade Likert scale.
Blood samples will be collected from all subjects during the screening period, after 6 months of intervention and at the completion of intervention (i.e. at month 12).
The following blood tests will be conducted:
325 studies on the registry are indexed under Osteoporosis, Postmenopausal; 28 are open to participants now.
This study's enrollment of 170 is above the median of 110 across 255 interventional studies indexed under Osteoporosis, Postmenopausal.
Browse Osteoporosis, Postmenopausal studies →Nordic Biotic Sp. z o.o. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A dietary supplement in the form of capsules containing probiotic bacterial strains.
Dietary Supplement: Probiotic
Placebo capsules with the same appearance and weight as probiotic capsules.
Other: Placebo
The patients who give their consent to take part in this study, will receive one time per day for a period of 12 month a capsule containing ten billions of Lactobacillus plantarum (LP 140 NORDBIOTIC™) and Lactobacillus paracasei (LPC 100 NORDBIOTIC™).
The patients who give their consent to take part in this study, will receive one time per day for a period of 12 months a capsule containing maltodextrin.
The effect of intervention on bone mineral density
Bone mineral density (BMD) of the lumbar segment of the spine (L1-L4) will be measured by two densitometry scans (DEXA) and presented as T-score. T-score is measured in standard deviations and reflects the difference between the patient's measured BMD and the mean value of BMD in healthy, young, matched controls (30-year-old women).
Time frame: From baseline and after 12 months of intervention
Changes in the level of calcium
The level of calcium will be measured in serum and expressed in mg/dL.
Time frame: From baseline and after 6 and 12 months of intervention
Changes in the level of phosphorus
The level of phosphorus will be measured in serum and expressed in mg/dL.
Time frame: From baseline and after 6 and 12 months of intervention
Changes in the level of alkaline phosphatase
The level of alkaline phosphatase will be measured in serum and expressed in U/L.
Time frame: From baseline and after 6 and 12 months of intervention
Changes in the level of vitamin D
The level of vitamin D will be measured in serum and expressed in ng/mL.
Time frame: From baseline and after 12 months of intervention
Changes in the level of C-reactive protein
The level of C-reactive protein will be measured in serum and expressed in mg/L.
Time frame: From baseline and after 6 and 12 months of intervention
Changes in Body Mass Index (BMI)
Weight and height will be combined to report BMI in kg/m2.
Time frame: From baseline and after 6 and 12 months of intervention
Changes in type of stools
The stool type will be assessed with the Bristol Stool Formation Scale. The Bristol Stool Formation Scale is designed to classify faeces into seven groups: type 1-2 indicate constipation, type 3-4 are "normal" stools; type 5-7 indicate diarrhea.
Time frame: From baseline for 12 months of intervention in 1 month intervals
Changes in the number of bowel movements
The number of bowel movements per day will be assessed as mean of bowel movements during the last 7 days before visit.
Time frame: From baseline for 12 months of intervention in 1 month intervals
Changes in severity of abdominal pain
The severity of pain will be assessed with a patient-defined 5 point Linkert scale: point 0 - no pain, and 1-4 the severity of pain with higher scores indicating worse pain.
Time frame: From baseline for 12 months of intervention in 1 month intervals
Changes in severity of bloating
The bloating will be assessed with a patient-defined 5 point Linkert scale: point 0 - no bloating, and 1-4 the severity of bloating with higher scores indicating worse bloating.
Time frame: From baseline for 12 months of intervention in 1 month intervals
Occurrence of adverse events
Adverse events will be recorded and described throughout the intervention period
Time frame: For 12 months of intervention in 1 month intervals
Satisfaction with the intervention
Satisfaction with the intervention will be assessed by a questionnaire consisting of 6 questions regarding satisfaction with the form of the preparation, ease of administration, benefits, and course of treatment on a scale of 1-7, with the higher the score, the higher the satisfaction.
Time frame: At months 2, 6, 10, and 12 of the intervention
Plan to share: No
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Nordic Biotic Sp. z o.o.