Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02422082
Other study ID # LRvBMD
Secondary ID
Status Completed
Phase N/A
First received April 10, 2015
Last updated April 17, 2018
Start date May 8, 2015
Est. completion date December 1, 2017

Study information

Verified date April 2018
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The role of the gut microbes for human health has gained considerable interest in recent years. Lactobacillus reuteri (L.reuteri) is a naturally occurring bacterial species in the human gut. L. reuteri has been widely studied in clinical trials of adults and children and treatment with L. reuteri is safe and is associated with health-promoting effects in humans. In animal models, L. reuteri has anti-inflammatory effects and in ovariectomized mice supplementation with L. reuteri partly prevented the bone loss induced by estrogen deficiency. Furthermore, both bone density and bone formation increased in male mice in another mice model. In mice with medically induced diabetes mellitus, L. reuteri reduced blood glucose and in a mouse model mimicking the metabolic syndrome, L. reuteri prevented diet-induced obesity. The present study is a double-blind, placebo-controlled, randomized, study in 90 elderly women with osteopenia recruited from the population. These women will be treated with L. reuteri or placebo orally twice daily for 12 months. The effects on bone will be investigated with dual energy x-ray absorptiometry, high-resolution peripheral quantitative computed tomography, and bone turnover markers. Hormones and markers of inflammation and metabolism will be followed as well as changes in the gut microbiota composition.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date December 1, 2017
Est. primary completion date September 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 75 Years to 80 Years
Eligibility Inclusion Criteria:

- bone mineral density T-score less than -1 but more than -2.5 in the total hip or femoral neck or lumbar spine (L1-L4) by dual energy x-ray absorptiometry

- signed informed consent

- stated availability throughout the entire study period

- mental ability to understand and willingness to fulfill all the details of the protocol

Exclusion Criteria:

- untreated hyperthyroidism

- rheumatoid arthritis

- diagnosed with disease causing secondary osteoporosis within the last year, including primary hyperparathyroidism, chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, or diabetes

- recently diagnosed malignancy (within the last 5 years)

- per oral corticosteroid use

- use of antiresorptive therapy, including systemic hormone replacement therapy, bisphosphonates, strontium ran elate

- use of teriparatide (current or during the last 3 years)

- participation in other clinical interventional trials

- use of antibiotics within 2 months preceding the inclusion

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
L. reuteri
Dietary supplementation with L. reuteri twice daily for 12 months
Placebo
Dietary supplementation with placebo twice daily for 12 months

Locations

Country Name City State
Sweden Geriatric Medicine, Mölndal Hospital Mölndal Västra Götaland

Sponsors (2)

Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden BioGaia AB

Country where clinical trial is conducted

Sweden, 

References & Publications (5)

Adams MR, Marteau P. On the safety of lactic acid bacteria from food. Int J Food Microbiol. 1995 Oct;27(2-3):263-4. — View Citation

Britton RA, Irwin R, Quach D, Schaefer L, Zhang J, Lee T, Parameswaran N, McCabe LR. Probiotic L. reuteri treatment prevents bone loss in a menopausal ovariectomized mouse model. J Cell Physiol. 2014 Nov;229(11):1822-30. doi: 10.1002/jcp.24636. — View Citation

Fåk F, Bäckhed F. Lactobacillus reuteri prevents diet-induced obesity, but not atherosclerosis, in a strain dependent fashion in Apoe-/- mice. PLoS One. 2012;7(10):e46837. doi: 10.1371/journal.pone.0046837. Epub 2012 Oct 9. — View Citation

McCabe LR, Irwin R, Schaefer L, Britton RA. Probiotic use decreases intestinal inflammation and increases bone density in healthy male but not female mice. J Cell Physiol. 2013 Aug;228(8):1793-8. doi: 10.1002/jcp.24340. — View Citation

Reid G, Kim SO, Köhler GA. Selecting, testing and understanding probiotic microorganisms. FEMS Immunol Med Microbiol. 2006 Mar;46(2):149-57. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Total tibia volumetric bone mineral density Change in percent in total tibia volumetric bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri 12 months
Secondary Trabecular volumetric bone mineral density Change in percent in trabecular volumetric bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri 12 months
Secondary Cortical volumetric bone mineral density Change in percent in cortical volumetric bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri 12 months
Secondary Cortical thickness Change in percent in cortical thickness compared to placebo group after 1 year of dietary supplementation with L. reuteri 12 months
Secondary Cortical porosity Change in percent in cortical porosity compared to placebo group after 1 year of dietary supplementation with L. reuteri 12 months
Secondary Areal bone mineral density Change in percent in areal bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri 12 months
Secondary Bone material strength index Change in percent in bone material strength index compared to placebo group after 1 year of dietary supplementation with L. reuteri 12 months
Secondary Blood pressure Change in percent in blood pressure compared to placebo group after 1 year of dietary supplementation with L. reuteri 12 months
Secondary Change in gut microbiota composition Change in percent in gut microbiota composition compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Ultrasensitive C-reactive protein Change in percent in ultrasensitive C-reactive protein in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Interleukin-10 Change in percent in interleukin-10 in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Interleukin-17 Change in percent in interleukin-17 in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Tumor-necrosis factor-alpha Change in percent in tumor-necrosis factor-alpha in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Tartrate-resistent alkaline phosphatase 5b Change in percent in tartrate-resistent alkaline phosphatase 5b in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Cross-linked N-terminal telopeptide Change in percent in cross-linked N-terminal telopeptide in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Bone-specific alkaline phosphatase Change in percent in bone-specific alkaline phosphatase in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Receptor activator of nuclear factor kappa B (RANK) Change in percent in RANK in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Receptor activator of nuclear factor kappa B ligand (RANK-ligand) Change in percent in RANK-ligand in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Osteocalcin Change in percent in osteocalcin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Blood glucose Change in percent in blood glucose compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Haemoglobin A1C Change in percent in haemoglobin A1C compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Apolipoprotein A1 (ApoA1) Change in percent in ApoA1 compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Apolipoprotein B (ApoB) Change in percent in ApoB compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Cholesterol Change in percent in cholesterol compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary High density lipoprotein (HDL) Change in percent in HDL compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Low density lipoprotein (LDL) Change in percent in LDL compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Triglycerides Change in percent in triglycerides compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Oxytocin Change in percent in oxytocin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Estradiol Change in percent in estradiol in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Leptin Change in percent in leptin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Adiponectin Change in percent in adiponectin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Testosterone Change in percent in testosterone in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri 3-12 months
Secondary Lean mass Change in percent in lean mass compared to placebo after 12 months of dietary supplementation with L. reuteri 12 months
Secondary Fat mass Change in percent in fat mass compared to placebo after 12 months of dietary supplementation with L. reuteri 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT04754711 - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition N/A
Active, not recruiting NCT05066477 - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Bone Mass Among Osteopenic Women N/A
Terminated NCT01902186 - Bone Mineral Density Changes in HIV-positive Females With Osteopenia Switching to Raltegravir Phase 4
Completed NCT01439139 - Bone UltraSonic Scanner (BUSS): Validation Study N/A
Not yet recruiting NCT01397838 - Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women Phase 1
Completed NCT01222026 - Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate Phase 4
Completed NCT01152580 - Melatonin Osteoporosis Prevention Study Phase 1
Completed NCT00789425 - Investigating the Effect of Standardized Olive Extract on Bone Turnover Markers in Postmenopausal Women Phase 2
Completed NCT00463268 - Osteoporosis Prevention With Low Dose Alendronate Phase 3
Completed NCT00655681 - Prevention of Post Operative Bone Loss in Children N/A
Completed NCT00798473 - Zoledronate for Osteopenia in Pediatric Crohn's Phase 3
Active, not recruiting NCT00076050 - Using Soy Estrogens to Prevent Bone Loss and Other Menopausal Symptoms Phase 3
Completed NCT00226031 - Optimal Management of Women With Wrist Fractures N/A
Enrolling by invitation NCT04752098 - A Study to Assess Metabolic Bone Disease of Prematurity Using an Acoustic Method N/A
Completed NCT04720833 - Effect of Dried Plum on Bone and Markers of Bone Status in Men N/A
Recruiting NCT05541432 - Finding the Optimal Resistance Training Intensity For Your Bones N/A
Active, not recruiting NCT05405894 - Efficacy of Zoledronic Acid to Prevent Bone Loss Following Denosumab Discontinuation
Completed NCT05457036 - Evaluation of the Effect of Spry Belt Treatment on Bone Turnover Marker Profile N/A
Completed NCT04040010 - The Effects of Bovine Colostrum in Bone Metabolism in Humans N/A
Completed NCT02731820 - Efficacy of Potassium Citrate in the Treatment of Postmenopausal Osteopenia N/A