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NCT Number: NCT02422082

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

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.

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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

75 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Geriatric Medicine, Mölndal Hospital

Mölndal, Västra Götaland County, 43180, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

L. reuteri

Dietary Supplement

Dietary supplementation with L. reuteri twice daily for 12 months

Other names: Lactobacillus reuteri ATCC PTA 6475

Placebo

Dietary Supplement

Dietary supplementation with placebo twice daily for 12 months

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Collaborators

  • BioGaia AB

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2015
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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