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

NCT02422082 | Completed DMC

• 1 other identifier: LRvBMD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia

Keywords

Osteopenia; Lactobacillus reuteri; Volumetric bone mineral density

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (33)

• Trabecular volumetric bone mineral density

  12 months

• Cortical volumetric bone mineral density

  12 months

• Cortical thickness

  12 months

• Cortical porosity

  12 months

• Areal bone mineral density

  12 months

Study Arms (2)

L. reuteri

ACTIVE COMPARATOR

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.

Dietary Supplement: L. reuteri

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

L. reuteri DIETARY_SUPPLEMENT

Dietary supplementation with L. reuteri twice daily for 12 months

Also known as: Lactobacillus reuteri ATCC PTA 6475

L. reuteri

Placebo DIETARY_SUPPLEMENT

Dietary supplementation with placebo twice daily for 12 months

Placebo

Eligibility Criteria

• Age: 75 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• BioGaia AB: collaborator

Study Sites (1)

Geriatric Medicine, Mölndal Hospital

Mölndal, Västra Götaland County, 43180, Sweden

Location

Related 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. doi: 10.1016/0168-1605(95)00067-t. No abstract available.

  PMID: 8579995 BACKGROUND

• 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.

  PMID: 16487295 BACKGROUND

• 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.

  PMID: 24677054 BACKGROUND

• 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.

  PMID: 23389860 BACKGROUND

• 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.

  PMID: 23056479 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mattias Lorentzon, MD, PhD

  Dept Geriatrics, Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Specialist physician

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 21, 2015
• Study Start: May 8, 2015
• Primary Completion: September 15, 2017
• Study Completion: December 1, 2017
• Last Updated: April 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)