CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
L. reuteri +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02422082
NCT02422082N/ACompleted

The Effect of Lactobacillus Reuteri ATCC PTA 6475 on Volumetric Bone Mineral Density in Patients With Osteopenia

Sahlgrenska University Hospital·interventional·Posted Apr 21, 2015·Updated Apr 18, 2018

In Brief

A clinical study evaluating L. reuteri and Placebo for Osteopenia. Completed, enrolled 90 participants across 1 site.

Detailed Summary

Lactobacillus reuteri (L. reuteri) has been widely studied in clinical trials and has probiotic, health-promoting effects in both adults and children, and is safe for human consumption. Animal models indicate that treatment with L. reuteri has positive effects on bone metabolism and bone density. In other animal models of diabetes and the metabolic syndrome, positive effects on blood glucose and weight have been reported. The present double-blind, placebo-controlled, randomized study is designed to investigate if dietary supplementation with L. reuteri twice daily for 12 months has any effect on bone density, body composition, inflammation, or metabolic and endocrine markers in elderly women with osteopenia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteopenia
CountriesSweden
CollaboratorsBioGaia AB

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 21, 2015
Enrollment StartMay 8, 2015
Primary CompletionSep 15, 2017
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 11.2 years ago

Interventions

L. reuteridietary

Dietary supplementation with L. reuteri twice daily for 12 months

Placebodietary

Dietary supplementation with placebo twice daily for 12 months