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

NCT ID: NCT02422082

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-08
• Study Completion Date: 2017-12-01

Brief 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.

Detailed 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.

Conditions

Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

L. reuteri

Lactobacillus reuteri (L. reuteri) ATCC PTA 6475 at a dose of 5 000 000 000 CFU as a powder in a stick-pack, orally twice daily (morning and evening) yielding a total daily dose of 10 000 000 000 CFU per day, for 12 months.

Group Type: ACTIVE_COMPARATOR

L. reuteri

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplementation with L. reuteri twice daily for 12 months

Placebo

Placebo product identical to the active product (L. reuteri) in taste and appearance but without the active component, orally twice daily, for 12 months.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Dietary supplementation with placebo twice daily for 12 months

Interventions

L. reuteri

Dietary supplementation with L. reuteri twice daily for 12 months

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Dietary supplementation with placebo twice daily for 12 months

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Lactobacillus reuteri ATCC PTA 6475

Eligibility Criteria

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

• Minimum Eligible Age: 75 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

BioGaia AB

INDUSTRY

Sponsor Role: collaborator

Sahlgrenska University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mattias Lorentzon

Professor, Specialist physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mattias Lorentzon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept Geriatrics, Sahlgrenska University Hospital

Locations

Geriatric Medicine, Mölndal Hospital

Mölndal, Västra Götaland County, Sweden

Countries

Sweden

References

Adams MR, Marteau P. On the safety of lactic acid bacteria from food. Int J Food Microbiol. 1995 Oct;27(2-3):263-4. doi: 10.1016/0168-1605(95)00067-t. No abstract available.

Reference Type: BACKGROUND

PMID: 8579995 (View on PubMed)

Reid G, Kim SO, Kohler GA. Selecting, testing and understanding probiotic microorganisms. FEMS Immunol Med Microbiol. 2006 Mar;46(2):149-57. doi: 10.1111/j.1574-695X.2005.00026.x.

Reference Type: BACKGROUND

PMID: 16487295 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24677054 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23389860 (View on PubMed)

Fak F, Backhed 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.

Reference Type: BACKGROUND

PMID: 23056479 (View on PubMed)

Other Identifiers

LRvBMD

Identifier Type: -

Identifier Source: org_study_id