Prevention of Glucocorticoid induced impairment of bone metabolism – A Randomized, Placebo-Controlled, Single Centre Clinical Trial

Phase 1

• Conditions: Oral glucocorticoid (GC) therapy leads to a rapid and profound effects on bone metabolism.The gut microbiota is involved in regulating bone metabolism.Lactobacillus reuteri (LR) has been shown to have probiotic, health-promoting effects.The aim of this randomized, double-blind, placebo-controlled trial is to investigate if daily supplementation with LR, compared to placebo, can prevent the negative effects of oral GC on bone turnover and on blood glucose regulation in healthy young adults.; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2021-000275-36-SE
• Lead Sponsor: Sahlgrenska University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-07
• Study Completion: 2022-12-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Healthy men and women, 18-45 years old.
•Stated availability throughout the entire study period.
•Ability to understand study instructions and willingness to adhere to the protocol.
•Signed informed consent.
•Have received full immunisation against Covid-19

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•History of diabetes or glucose intolerance, defined as an abnormal oral glucose tolerance test (OGTT).
•Obesity, BMI>30 kg/m2
•History of adrenal disease or impairment.
•Previous (within the last 5 years) or current use of antiresorptive therapy, including systemic hormone therapy (estrogen), bisphosphonates, strontium ranelate or denosumab.
•Participation in other clinical trials.
•Current antibiotics treatment or within the last 2 months prior to inclusion.
•Current and within the past 2 months use of probiotic supplement.
•Untreated hyperthyroidism or hyperthyroidism within the last 5 years.
•Known untreated hyperparathyroidism.
•Rheumatoid arthritis.
•Diagnosed with disease causing secondary osteoporosis, including chronic obstructive pulmonary disease, inflammatory bowel disease, celiac disease, or diabetes mellitus.
•Recently diagnosed malignancy (within the last 5 years).
•Systemic skeletal disease (including e.g. Paget’s disease and osteogenesis imperfecta).
•Any systemic disease that could affect bone loss, as judged by the investigator.
•Oral corticosteroid use.
•History of peptic ulcer.
•Diagnosed osteoporosis.
•Current smoking or other use of nicotine containing products.
•Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified