Prevention of Early Postmenopausal Bone Loss With Lactobacillus Reuteri

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-04

Study Completion Date

2022-10-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02422082

Osteopenia

COMPLETED NA

Prevention of Glucocorticoid Induced Impairment of Bone Metabolism

NCT04767711

Bone Loss

COMPLETED NA

Food Trial Evaluating the Efficacy of SBD111 Versus Placebo for the Clinical Dietary Management of the Metabolic Processes of Osteopenia

NCT05009875

Osteopenia

COMPLETED NA

Effects of Teriparatide in the Treatment of Postmenopausal Women With Osteoporosis

NCT00670501

Osteoporosis, Postmenopausal

COMPLETED PHASE3

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

NCT04757376

Postmenopausal Women With Osteoporosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Postmenopausal Osteoporosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

L. reuteri Low Dose

Capsules of freeze-dried L. reuteri 6475 of 5x10E8 colony-forming units (CFU) mixed with maltodextrin powder and 200 IU of cholecalciferol, taken twice daily for 24 months, yielding a total dose of either 1x10E9 L.reuteri CFU and 400 IU of cholecalciferol per day.

Group Type ACTIVE_COMPARATOR

Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)

Intervention Type DIETARY_SUPPLEMENT

L.reuteri high or low dose with cholecalciferol compared to cholecalciferol only.

L. reuteri High Dose

Capsules of freeze-dried L. reuteri 6475 of 5x10E9 colony-forming units (CFU) mixed with maltodextrin powder and 200 IU of cholecalciferol, taken twice daily for 24 months, yielding a total daily dose of 1x10E10 L.reuteri CFU and 400 IU of cholecalciferol per day.

Group Type ACTIVE_COMPARATOR

Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)

Intervention Type DIETARY_SUPPLEMENT

L.reuteri high or low dose with cholecalciferol compared to cholecalciferol only.

Placebo

Placebo product identical to the active product (L. reuteri) in taste and appearance but without the active component, orally twice daily, for 24 months.The placebo product contains 200 IU cholecalciferol per dose, yielding a total dose of cholecalciferol of 400 IU per day.

Group Type PLACEBO_COMPARATOR

Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)

Intervention Type DIETARY_SUPPLEMENT

L.reuteri high or low dose with cholecalciferol compared to cholecalciferol only.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)

L.reuteri high or low dose with cholecalciferol compared to cholecalciferol only.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Postmenopausal women, 45 years or older, within 1-4 years from their last menses.
* Vitamin D levels above 25 nmol/L.
* Signed informed consent.
* Stated availability throughout the entire study period.
* Ability to understand study instructions and willingness to adhere to the protocol.

Exclusion Criteria

* Bone mineral density of \< -2.5 combined with a fracture risk assessment tool (FRAX) score of 20% or higher for major osteoporotic fracture.
* Severe osteoporosis, defined as bone mineral density of \< -3.0 in either the total hip, femur neck or lumbar spine L1-L4.
* Vertebral fracture (grade II or III) diagnosed using lateral spine imaging with DXA.
* Untreated hyperthyroidism or hyperthyroidism within the last 5 years.
* Known untreated hyperparathyroidism.
* Rheumatoid arthritis.
* Diagnosed with disease causing secondary osteoporosis, including chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, or diabetes mellitus.
* Recently diagnosed malignancy (within the last 5 years).
* Oral corticosteroid use.
* Previous (within the last 5 years) use of antiresorptive therapy, including systemic hormone therapy (estrogen), bisphosphonates, strontium ranelate or denosumab.
* Systemic skeletal disease (including e.g. Paget's disease and osteogenesis imperfecta).
* Any systemic disease that could affect bone loss, as judged by the investigator.
* Use of teriparatide (current or during the last 3 years).
* Participation in other clinical trials.
* Current antibiotics treatment or within the last 2 months prior to inclusion.
* Current and within the past 2 months use of probiotic supplement
* Vitamin D deficiency (25-OH vitamin D\<25 nmol/l)
* Hypo- or hypercalcemia.
* Osteosynthesis materials in both lower legs (tibia).

Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes