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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02422082
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : April 18, 2018
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Mattias Lorentzon, Sahlgrenska University Hospital, Sweden

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.

Condition or disease Intervention/treatment Phase
Osteopenia Dietary Supplement: L. reuteri Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Lactobacillus Reuteri ATCC PTA 6475 on Volumetric Bone Mineral Density in Patients With Osteopenia
Actual Study Start Date : May 8, 2015
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Dietary Supplement: L. reuteri
Dietary supplementation with L. reuteri twice daily for 12 months
Other Name: Lactobacillus reuteri ATCC PTA 6475

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




Primary Outcome Measures :
  1. Total tibia volumetric bone mineral density [ Time Frame: 12 months ]
    Change in percent in total tibia volumetric bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri


Secondary Outcome Measures :
  1. Trabecular volumetric bone mineral density [ Time Frame: 12 months ]
    Change in percent in trabecular volumetric bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri

  2. Cortical volumetric bone mineral density [ Time Frame: 12 months ]
    Change in percent in cortical volumetric bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri

  3. Cortical thickness [ Time Frame: 12 months ]
    Change in percent in cortical thickness compared to placebo group after 1 year of dietary supplementation with L. reuteri

  4. Cortical porosity [ Time Frame: 12 months ]
    Change in percent in cortical porosity compared to placebo group after 1 year of dietary supplementation with L. reuteri

  5. Areal bone mineral density [ Time Frame: 12 months ]
    Change in percent in areal bone mineral density compared to placebo group after 1 year of dietary supplementation with L. reuteri

  6. Bone material strength index [ Time Frame: 12 months ]
    Change in percent in bone material strength index compared to placebo group after 1 year of dietary supplementation with L. reuteri

  7. Blood pressure [ Time Frame: 12 months ]
    Change in percent in blood pressure compared to placebo group after 1 year of dietary supplementation with L. reuteri

  8. Change in gut microbiota composition [ Time Frame: 3-12 months ]
    Change in percent in gut microbiota composition compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  9. Ultrasensitive C-reactive protein [ Time Frame: 3-12 months ]
    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

  10. Interleukin-10 [ Time Frame: 3-12 months ]
    Change in percent in interleukin-10 in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  11. Interleukin-17 [ Time Frame: 3-12 months ]
    Change in percent in interleukin-17 in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  12. Tumor-necrosis factor-alpha [ Time Frame: 3-12 months ]
    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

  13. Tartrate-resistent alkaline phosphatase 5b [ Time Frame: 3-12 months ]
    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

  14. Cross-linked N-terminal telopeptide [ Time Frame: 3-12 months ]
    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

  15. Bone-specific alkaline phosphatase [ Time Frame: 3-12 months ]
    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

  16. Receptor activator of nuclear factor kappa B (RANK) [ Time Frame: 3-12 months ]
    Change in percent in RANK in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  17. Receptor activator of nuclear factor kappa B ligand (RANK-ligand) [ Time Frame: 3-12 months ]
    Change in percent in RANK-ligand in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  18. Osteocalcin [ Time Frame: 3-12 months ]
    Change in percent in osteocalcin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  19. Blood glucose [ Time Frame: 3-12 months ]
    Change in percent in blood glucose compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  20. Haemoglobin A1C [ Time Frame: 3-12 months ]
    Change in percent in haemoglobin A1C compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  21. Apolipoprotein A1 (ApoA1) [ Time Frame: 3-12 months ]
    Change in percent in ApoA1 compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  22. Apolipoprotein B (ApoB) [ Time Frame: 3-12 months ]
    Change in percent in ApoB compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  23. Cholesterol [ Time Frame: 3-12 months ]
    Change in percent in cholesterol compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  24. High density lipoprotein (HDL) [ Time Frame: 3-12 months ]
    Change in percent in HDL compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  25. Low density lipoprotein (LDL) [ Time Frame: 3-12 months ]
    Change in percent in LDL compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  26. Triglycerides [ Time Frame: 3-12 months ]
    Change in percent in triglycerides compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  27. Oxytocin [ Time Frame: 3-12 months ]
    Change in percent in oxytocin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  28. Estradiol [ Time Frame: 3-12 months ]
    Change in percent in estradiol in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  29. Leptin [ Time Frame: 3-12 months ]
    Change in percent in leptin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  30. Adiponectin [ Time Frame: 3-12 months ]
    Change in percent in adiponectin in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  31. Testosterone [ Time Frame: 3-12 months ]
    Change in percent in testosterone in serum compared to placebo after 3, 6, 9, and 12 months of dietary supplementation with L. reuteri

  32. Lean mass [ Time Frame: 12 months ]
    Change in percent in lean mass compared to placebo after 12 months of dietary supplementation with L. reuteri

  33. Fat mass [ Time Frame: 12 months ]
    Change in percent in fat mass compared to placebo after 12 months of dietary supplementation with L. reuteri



Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years to 80 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02422082


Locations
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Sweden
Geriatric Medicine, Mölndal Hospital
Mölndal, Västra Götaland, Sweden, 43180
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
BioGaia AB
Investigators
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Principal Investigator: Mattias Lorentzon, MD, PhD Dept Geriatrics, Sahlgrenska University Hospital
Publications:
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Responsible Party: Mattias Lorentzon, Professor, Specialist physician, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02422082    
Other Study ID Numbers: LRvBMD
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mattias Lorentzon, Sahlgrenska University Hospital, Sweden:
Osteopenia
Lactobacillus reuteri
Volumetric bone mineral density
Additional relevant MeSH terms:
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Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases