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The effects of probiotics on bone loss/bone mineral density in early postemenopausal women

The effectiveness of a lactobacilli- based probiotic food supplement on bone metabolism and bone mineral density in Australian early postmenopausal women: A double- blind randomised placebo- controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000810819
Acronym
Probone21
Enrollment
114
Registered
2021-06-28
Start date
2021-12-01
Completion date
2023-06-20
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Osteoporosis is a degenerative disease of the bone, which although occurs in older ages, has its roots in earlier life stages. Women are in general more susceptible to osteoporosis-related bone fractures than men, especially during the perimenopausal period, when the decrease in their oestrogen levels accelerates bone loss. Nevertheless, the increase of life expectancy in developed countries puts older men in a high risk of bone fractures too, especially after the age of 65 years. The adequate intake of certain nutrients that are essential for bone metabolism, such as calcium and vitamin D, plays an important role in maintaining bone mass. As such, supplementation with calcium and/or vitamin D has been reported to exert a significant favourable effect on bone metabolism and bone mineral density (BMD). Nevertheless, the low-grade inflammation induced by a shift in the balance of gut bacterial composition has been reported to impair the absorption of dietary calcium and other important nutrients, while at the same time it seems to stimulate bone resorption through an accelerated activity of osteoclasts. In this regard, it is now clear that the gut microbiome modulates bone haemostasis in mice, by regulating the immune system and osteoclast formation. The implication of this observation is that the modulation of the microbiome and/or inflammation may provide a new approach in the inhibition of age- and menopause-related bone loss and the prevention of osteoporosis. Aim: The aim of the proposed study is to examine the effect of a 12-month supplementation with a probiotic supplement that combines three strains of Lactobacillus on bone metabolism as well as on volumetric and areal BMD in Australian early postmenopausal females, aged 45-65 years, with an increased risk for osteoporosis.

Interventions

The intervention consists of capsules containing probiotic food supplement that combines a mix of selected probiotic bacteria (Lactobacillus - containing 10 billion CFU) in a dosage of one capsule daily for 12 months.

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

- Willingness to participate and availability throughout the study period - 10-year major fracture risk (based on FRAX score) ranging from 5% in 45-year-old women to 15% in 65-year-old women. - QUS heel BMD T-score greater than -2.5 standard deviation - Early postmenopausal women, i.e. < 6 years since menopause - Signed informed consent to participate to the study

Exclusion criteria

- QUS heel BMD T-score less than or equal to -2.5 (i.e. potential presence of osteoporosis) - Normal menstrual cycle or more than 6 years post menopause - Younger than 45 years old and older than 65 years old. - Medication that affects BMD - Presence of disease: diabetes, untreated hyperthyroidism or hypothyroidism, hyperparathyroidism, impaired renal and liver function, malignancy diagnosed during the last 5 years, inflammatory bowel disease, celiac disease, chronic obstructive pulmonary disease, rheumatoid arthritis. - Smoking or use of nicotine-containing products (currently or during the last six [6] months). - Alcohol consumption more than 4 units per day.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 6, 2026