The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women (NCT06375668) | Clinical Trial Compass
CompletedNot Applicable
The Effect of the Probiotic Strains on Bone Mineral Density in Postmenopausal Women
Poland170 participantsStarted 2022-03-15
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The effect of intervention on bone mineral density
Timeframe: From baseline and after 12 months of intervention