This study evaluates the effect of two different doses of Lactobacillus reuteri ATCC PTA 6475 (L.reuteri 6475) on bone loss in early postmenopausal women. One third of the participants will be randomised to the lower dose, one third to the higher dose and one third to placebo.
We have previously shown that daily supplementation of the probiotic Lactobacillus reuteri ATCC PTA 6475 (10E10 colony-forming units (CFU)) was able to reduce bone loss over 12 months in 76-year-old women compared to placebo. It is not known if the probiotic is effective over longer time periods or if the effect is dose-dependent. The aim of this study is to investigate if two different doses of Lactobacillus reuteri ATCC PTA 6475 (total daily dose of either 1x10E9 or 1x10E10 CFU/day) can prevent or reduce bone loss, compared to placebo, in early (1-4 years since last menses) postmenopausal women over 24 months. All women will receive 400 IU of vitamin D (cholecalciferol) per day. Changes in bone mineral density, bone geometry and microstructure will be measured using dual x-ray absorptiometry and high resolution peripheral computed tomography.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
239
L.reuteri high or low dose with cholecalciferol compared to cholecalciferol only.
Geriatric Medicine, Sahlgrenska University Hospital, Mölndal
Gothenburg, Västra Götaland County, Sweden
Total tibia volumetric bone mineral density
Measured using high resolution peripheral computed tomography (HRpQCT), relative change 0-24 months
Time frame: 24 months
Areal bone mineral density (aBMD) at the lumbar spine
Measured using dual x-ray absorptiometry (DXA), relative change 0-24 months and 0-12 months
Time frame: 24 months
Areal BMD of the total hip (DXA)
Measured using DXA, relative change 0-24 months and 0-12 months
Time frame: 0-24 months and 0-12 months
Tibia trabecular bone volume fraction
Measured using HRpQCT, relative change 0-24 months and 0-12 months
Time frame: 0-24 months and 0-12 months
Tibia cortical area
Measured using HRpQCT, relative change 0-24 months and 0-12 months
Time frame: 0-24 months and 0-12 months
Tibia cortical volumetric BMD
Measured using HRpQCT, relative change 0-24 months and 0-12 months
Time frame: 0-24 months and 0-12 months
Total tibia volumetric bone mineral density
Measured using HRpQCT, relative change 0-12 months
Time frame: 12 months
Blood bone formation marker procollagen type 1N propeptide (P1NP)
Relative change 0-24 months and 0-12 months
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Time frame: 0-24 months and 0-12 months
Blood bone resorption marker C-terminal cross-linking telopeptide of type I collagen (CTX)
Relative change 0-24 months and 0-12 months
Time frame: 0-24 months and 0-12 months
Fecal calprotectin
Relative change 0-24 months and 0-12 months
Time frame: 0-24 months and 0-12 months
Fecal lipocalin-2
Relative change 0-24 months and 0-12 months
Time frame: 0-24 months and 0-12 months
Serum butyrate concentration
Relative change 0-24 months and 0-12 months
Time frame: 0-24 months and 0-12 months
Serum Wnt10b concentration
Relative change 0-24 months and 0-12 months
Time frame: 0-24 months and 0-12 months