Prevention of Glucocorticoid Induced Impairment of Bone Metabolism
Status:
Not yet recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
Summary
Glucocorticoid (GC) therapy is used to treat a variety of inflammatory conditions such as
rheumatoid arthritis, inflammatory bowel disease, bronchial asthma, allergies, ankylosing
spondylitis and some forms of cancers. Despite the well-known side-effects, GC treatment is
widely used. Oral GC therapy leads to a rapid and profound effects on bone metabolism, with
increased osteoblast apoptosis and prolonged osteoclast survival, which increases bone
resorption, resulting in bone loss, and a subsequent increased fracture risk. Within days of
high dose oral GC, glucose tolerance decreases and bone turnover is shifted in favour of less
bone formation and increased bone resorption. Bone formation and bone resorption can be
estimated by measuring serum bone turnover markers.
The gut microbiota is involved in regulating bone metabolism and recently it was demonstrated
that Lactobacillus reuteri 6475 (LR) could reduce bone loss over 12 months by half in older
women. In a recent experimental study, it was discovered that mice treated either with broad
spectrum antibiotics, eradicating gut microbiota, or with LR did not experience GC induced
bone loss in the spine and femur. L. reuteri has been widely studied in clinical trials and
has been shown to have probiotic, health-promoting effects in both adults and children.
The aim of this planned randomized, double-blind, placebo-controlled trial is to investigate
if daily supplementation with LR, compared to placebo, can prevent the negative effects of
oral glucocorticoid (GC) on bone turnover and on blood glucose regulation in healthy young
adult men and women.
If LR is able to prevent deleterious side effects, such as bone loss and impaired glucose
tolerance, of oral GC treatment, the probiotic could potentially be recommended and used to
improve health in a substantial yearly number of patients treated with GC.