Overview

This trial is active, not recruiting.

Condition osteopenia
Treatments l. reuteri, placebo
Phase phase 2
Sponsor Sahlgrenska University Hospital, Sweden
Collaborator BioGaia AB
Start date April 2015
End date June 2017
Trial size 90 participants
Trial identifier NCT02422082, LRvBMD

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(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.
l. reuteri Lactobacillus reuteri ATCC PTA 6475
Dietary supplementation with L. reuteri twice daily for 12 months
(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.
placebo
Dietary supplementation with placebo twice daily for 12 months

Primary Outcomes

Measure
Total tibia volumetric bone mineral density
time frame: 12 months

Secondary Outcomes

Measure
Trabecular volumetric bone mineral density
time frame: 12 months
Cortical volumetric bone mineral density
time frame: 12 months
Cortical thickness
time frame: 12 months
Cortical porosity
time frame: 12 months
Areal bone mineral density
time frame: 12 months
Change in gut microbiota composition
time frame: 3-12 months
Ultrasensitive C-reactive protein
time frame: 3-12 months
Interleukin-10
time frame: 3-12 months
Interleukin-17
time frame: 3-12 months
Tumor-necrosis factor-alpha
time frame: 3-12 months
Tartrate-resistent alkaline phosphatase 5b
time frame: 3-12 months
Cross-linked N-terminal telopeptide
time frame: 3-12 months
Bone-specific alkaline phosphatase
time frame: 3-12 months
Receptor activator of nuclear factor kappa B (RANK)
time frame: 3-12 months
Receptor activator of nuclear factor kappa B ligand (RANK-ligand)
time frame: 3-12 months
Osteocalcin
time frame: 3-12 months
Blood glucose
time frame: 3-12 months
Haemoglobin A1C
time frame: 3-12 months
Apolipoprotein A1 (ApoA1)
time frame: 3-12 months
Apolipoprotein B (ApoB)
time frame: 3-12 months
Cholesterol
time frame: 3-12 months
High density lipoprotein (HDL)
time frame: 3-12 months
Low density lipoprotein (LDL)
time frame: 3-12 months
Triglycerides
time frame: 3-12 months
Oxytocin
time frame: 3-12 months
Estradiol
time frame: 3-12 months
Leptin
time frame: 3-12 months
Adiponectin
time frame: 3-12 months
Testosterone
time frame: 3-12 months
Lean mass
time frame: 12 months
Fat mass
time frame: 12 months

Eligibility Criteria

Female participants from 75 years up to 80 years old.

Inclusion Criteria: - bone mineral density T-score less than -1 but more than -2.5 in the total hip 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

Additional Information

Official title The Effect of Lactobacillus Reuteri ATCC PTA 6475 on Volumetric Bone Mineral Density in Patients With Osteopenia
Principal investigator Mattias Lorentzon, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Sahlgrenska University Hospital, Sweden.