The Effect of Lactobacillus Reuteri ATCC PTA 6475 on Volumetric Bone Mineral Density in Patients With Osteopenia
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ClinicalTrials.gov Identifier: NCT02422082 |
Recruitment Status :
Completed
First Posted : April 21, 2015
Last Update Posted : April 18, 2018
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Condition or disease | Intervention/treatment | Phase |
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Osteopenia | Dietary Supplement: L. reuteri Dietary Supplement: Placebo | Not Applicable |
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 |

Arm | Intervention/treatment |
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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.
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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.
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Dietary Supplement: Placebo
Dietary supplementation with placebo twice daily for 12 months |
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- Lean mass [ Time Frame: 12 months ]Change in percent in lean mass compared to placebo after 12 months of dietary supplementation with L. reuteri
- Fat mass [ Time Frame: 12 months ]Change in percent in fat mass compared to placebo after 12 months of dietary supplementation with L. reuteri

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

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
Sweden | |
Geriatric Medicine, Mölndal Hospital | |
Mölndal, Västra Götaland, Sweden, 43180 |
Principal Investigator: | Mattias Lorentzon, MD, PhD | Dept Geriatrics, Sahlgrenska University Hospital |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osteopenia Lactobacillus reuteri Volumetric bone mineral density |
Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |