The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women

NCT06375668 | Completed

• 1 other identifier: CT/NB/140/2020/PR-MS
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Bone Density, Low; Osteoporosis, Postmenopausal

Keywords

bone mineral density; osteoporosis; probiotics

Outcome Measures

Primary Outcomes (1)

• 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).

  From baseline and after 12 months of intervention

Secondary Outcomes (12)

• Changes in the level of calcium

  From baseline and after 6 and 12 months of intervention

• Changes in the level of phosphorus

  From baseline and after 6 and 12 months of intervention

• Changes in the level of alkaline phosphatase

  From baseline and after 6 and 12 months of intervention

• Changes in the level of vitamin D

  From baseline and after 12 months of intervention

• Changes in the level of C-reactive protein

  From baseline and after 6 and 12 months of intervention

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

A dietary supplement in the form of capsules containing probiotic bacterial strains.

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Placebo capsules with the same appearance and weight as probiotic capsules.

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

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™).

Probiotic

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women (between 2 and 5 years after their last menstrual period)
• A dual-energy X-ray absorptiometry (DEXA) scan-based T-score of the lumbar spine (L1-L4) of less than -1.49 (i.e. a normal value according to the World Health Organization)
• Body mass index (BMI) between 18 and 30
• Vitamin 25 (OH)D levels between 31-50 ng/mL

You may not qualify if:

• The last menstrual period less than 2 or more than 5 years before study recruitment
• BMI under 18 or above 30
• Oral or transdermal hormone therapy with estrogens and/or progestogens within the last 6 months
• Corticosteroid or thyroid hormone therapy within the last 6 months
• History of osteopenia or osteoporosis
• Neoplastic disease treated with cytostatic agents within the last 12 months
• Autoimmune disorders, including rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis; malabsorption syndromes, including celiac disease; chronic kidney disease; chronic liver failure; endocrine disorders, including Hashimoto thyroiditis, Graves' disease, Cushing disease or syndrome, hyperparathyroidism, hypogonadism, hyperprolactinemia, acromegaly, diabetes mellitus; and other chronic conditions affecting bone metabolism
• Antibiotic therapy within the last 2 months prior to study recruitment
• Probiotic use within the last 2 months prior to study recruitment
• Calcium and vitamin D supplementation within the 2 months prior to study recruitment
• Treatment with antidepressant or antipsychotic agents involving a change of the agents or dosage within the last 3 months
• Substance use disorder (alcohol, drugs, nicotine)
• History of organ transplantation
• Exposure to the SARS-Cov-2 virus within 14 days prior to study recruitment (based on patient declaration)
• An acute COVID-19 infection within 14 days prior to study recruitment (based on patient declaration)

Sponsors & Collaborators

• Nordic Biotic Sp. z o.o.: lead

Study Sites (3)

Private Specialist Practice

Bytom, 41-902, Poland

Location

Specialist Practice

Katowice, 40-750, Poland

Location

Clinical Research Center

Poznan, 60-773, Poland

Location

Related Publications (1)

• Glogowska-Szelag J, Palka-Kisielowska I, Porawska W, Bierla JB, Szczepankowska AK, Aleksandrzak-Piekarczyk T, Cukrowska B. The Effect of Lacticaseibacillus paracasei LPC100 and Lactiplantibacillus plantarum LP140 on Bone Mineral Density in Postmenopausal Women: A Multicenter, Randomized, Placebo-Controlled Study. J Clin Med. 2024 Oct 8;13(19):5977. doi: 10.3390/jcm13195977.

  PMID: 39408038 DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal; Bone Diseases, Metabolic; Osteoporosis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Joanna Głogowska-Szeląg, MD, PhD

  Private Specialist Practice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: March 15, 2022
• Primary Completion: January 15, 2024
• Study Completion: June 15, 2024
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3)