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

NCT02422082 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-04-18

No results posted yet for this study

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.

Conditions

  • Osteopenia

Interventions

DIETARY_SUPPLEMENT

L. reuteri

Dietary supplementation with L. reuteri twice daily for 12 months

DIETARY_SUPPLEMENT

Placebo

Dietary supplementation with placebo twice daily for 12 months

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY

  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Mattias Lorentzon, MD, PhD · Dept Geriatrics, Sahlgrenska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
75 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-08
Primary Completion
2017-09-15
Completion
2017-12-01

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02422082 on ClinicalTrials.gov