NCT04169789

Prevention of Early Postmenopausal Bone Loss With Lactobacillus Reuteri

Prevention of Early Postmenopausal Bone Loss With Lactobacillus Reuteri - A Randomized, Placebo-Controlled, Single Centre Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)	L.reuteri high or low dose with cholecalciferol compared to cholecalciferol only.

Timeline

• Start date: 2019-12-04
• Primary completion: 2022-10-18
• Completion: 2022-10-18
• First posted: 2019-11-20
• Last updated: 2023-02-06

Locations

1 site across 1 country: Sweden