Bone LossNCT04767711
Prevention of Glucocorticoid Induced Impairment of Bone Metabolism
A study testing Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475) and Prednisolone in people with Bone Loss, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475) and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- 16 May 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Vaccinated for Covid-19
Who cannot join
- 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.
Show all 20Show fewer
- 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.
- History of any psychiatric disorder, including psychosis, depression, anxiety disorder and bipolar disorder.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Geriatric Medicine, Sahlgrenska University Hospital
Mölndal, 43180
About this study
Official title: Prevention of Glucocorticoid Induced Impairment of Bone Metabolism - A Randomized, Placebo-Controlled, Single Centre Clinical Trial
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.
Read more
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.
Read the detailed description
By advertising in newspapers, in shops, health clubs, in public places, and on social media platforms, and by contacting interested persons (by mail and phone) identified publicly available websites (e.g. www.ratsit.se), 46 young, healthy men and women will be recruited, to participate in the study. Study subjects will be contacted by phone and receive more information regarding the study and undergo a preliminary evaluation about eligibility to participate. Detailed study information will be sent by mail to study subjects. At the screening visit, participants will receive information about the study verbally, and if participants sign the informed consent form, participants will undergo a test of fasting blood glucose, HbA1c, and an oral glucose tolerance test (OGTT). A standardized self-reported questionnaire will be used to collect information at the screening visit about smoking habits, calcium intake, medical history, medications, previous fractures, physical activity, and diet habits. Eligible participants are then invited to the randomization visit. At the randomization visit, the study subjects will be asked to refrain from physical exercise, other than walking and keep an unchanged normal diet from study day 14. Randomization will be carried out by the supplier of LR (BioGaiaAB). The investigators will not have access to the randomization code and blinding will be maintained until study end and database lock. After randomization, study participants will consume either LR or placebo for 30 days. After the 14-day run-in period, all participants will start taking 25 mg of oral prednisolone every morning for 7 days. At the 14-day visit, a 24-hour glucose monitoring for the following 10 days will be started. At the next visit on day 16, fasting blood samples will be drawn in the morning (7-9 am), feces samples provided (within 24 hours of collection) and participants will start the oral GC treatment on that visit after blood samples have been drawn. At the 19-, 23- and 30-day visits, blood samples will be drawn in the morning (7-9 am for all visits, prior to taking the GC dose). Feces samples will also be collected at these visits. Included participants will be asked to come to the clinic and report compliance and possible adverse events during the duration of the study and at all visits.
Analyses.
Questionnaires:
A standardized questionnaire will be used to collect information at the screening visit about smoking habits, calcium intake, medical history (e.g. stroke, rheumatoid arthritis, and diabetes), medications, and previous fractures. Current physical activity and diet habits will be assessed by self-reported questionnaires (IPAQ and FFQ) at baseline. Daily intake of calcium will be calculated from the questionnaires about calcium-containing foods (e.g. dairy products, vegetables etc). Gastrointestinal symptoms will be analyzed using the GSRS questionnaire.
Serum, plasma, and stool analyses:
Serum and plasma will be collected in the morning (fasting), frozen, and stored at -80° C until further analyses. Samples from day 16 will be drawn prior to oral GC treatment start. A maximum of 30 ml of blood will be collected at each visit. Fasting blood glucose will be analyzed using fresh blood at screening (with the addition of HbA1c at screening), and days 16 (GC start), 19, 23, and 30. Serum and plasma samples will be frozen immediately and kept until analysis. Analyses of serum or plasma and bone markers (osteocalcin, P1NP, and CTX) will be performed using commercially available immunosorbent assays. Stool samples will be collected within 24 hours since produced and stored at -80oC until further analysis.
Oral glucose tolerance test (OGTT):
At the screening visit, a morning fasting blood glucose will be measured, followed by ingestion of 24 cl of glucose syrup, containing 75 grams of sugar. After 2 hours another blood glucose measurement will be performed. Inclusion in the study will depend on having a normal fasting blood glucose (≤6 mmol/l) and OGTT (<7.8 mmol/l).
Markers of intestinal permeability and intestinal inflammation:
Analyses of markers for intestinal permeability (endotoxin analysis, PyroGeneTM Recombinant Factor C Endpoint Fluorescent Assay) will be performed using a fluorescent assay at day 16, day 19, and day 23. Markers of intestinal inflammation (lipocalin-2 and calprotectin) will also be analyzed in feces and serum.
Analyses of gut microbiota - exploratory analyses:
DNA from feces samples will be isolated using a well-validated protocol and perform PCR to amplify the variable regions (V4) of the bacterial 16S rRNA gene using barcoded primers. Metagenome analyses of all samples will also be performed.
Continuous glucose monitoring:
On study day 14, continuous glucose monitoring (CGM) will be started, allowing a 48-hour observation period prior to commencement of oral prednisolone dosing. CGM will be used from day 14 until prednisolone treatment cessation on day 23. The Dexcom G6 system will be used for CGM on all participants.
- Conditions
- Bone Loss
- Being tested
- Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475), Prednisolone
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)Dietary supplement
L.reuteri with cholecalciferol compared to cholecalciferol only.
PrednisoloneDrug
Oral glucocorticoid 25 mg daily for 7 days.
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri | Active comparator | Capsules of freeze-dried L. reuteri 6475 of 5x10E9 colony-forming units (CFU) mixed with maltodextrin powder and 200 IU of cholecalciferol, taken twice daily for 30 days, yielding a total daily dose of 1x10E10 L.reuteri CFU and 400 IU of cholecalciferol per day. Oral glucocorticoid 25 mg daily for 7 days. Receives: Dietary Supplement: Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475); Drug: Prednisolone |
| Placebo | Placebo comparator | Placebo product identical to the active product (L. reuteri) in taste and appearance but without the active component, orally twice daily, for 30 days.The placebo product contains 200 IU cholecalciferol per dose, yielding a total dose of cholecalciferol of 400 IU per day. Oral glucocorticoid 25 mg daily for 7 days. Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone turnover marker serum osteocalcin
Between group percent change in bone turnover markers osteocalcin between baseline (day 16, prior to GC treatment start) and day 23 (7 days after starting oral GC).
Measured: Baseline (day 16) to day 23
Change in bone turnover marker serum PINP
Between group percent change in bone turnover markers serum PINP between baseline (day 16, prior to GC treatment start) and day 23 (7 days after starting oral GC).
Measured: Baseline (day 16) to day 23
Change in bone turnover marker serum CTX
Between group per cent change in bone turnover marker serum CTX between baseline (day 16, prior to GC treatment start) and day 23 (7 days after starting oral GC).
Measured: Baseline (day 16) to day 23
Secondary outcomes (7)
Change in blood glucose levels
Change in blood glucose levels (area under the curve, mmol/L) using continuous glucose monitoring (CGM) between baseline (day 14-16) and days 16-23.
Measured: Day 14-16 to day 16-23
Change in serum marker of intestinal permeability - endotoxin levels
Change between baseline (day 16) and day 23 in serum markers of intestinal permeability (endotoxin levels, % change).
Measured: Baseline (day 16) to day 23
Change in feces marker lipocalin-2 of intestinal inflammation
Percent change between baseline (day 16) and day 23 in feces marker lipocalin-2 of intestinal inflammation.
Measured: Baseline (day 16) and day 23
Change in feces marker calprotectin of intestinal inflammation
Percent change between baseline (day 16) and day 23 in feces marker calprotectin of intestinal inflammation.
Measured: Baseline (day 16) and day 23
Change in serum marker lipocalin-2 of intestinal inflammation
Percent change between baseline (day 16) and day 23 in serum marker lipocalin-2 of intestinal inflammation
Measured: Baseline (day 16) and day 23
Change in serum marker calprotectin of intestinal inflammation
Percent change between baseline (day 16) and day 23 in serum marker calprotectin of intestinal inflammation.
Measured: Baseline (day 16) and day 23
Change in the gut microbiota composition
Change in the gut microbiota composition between baseline (day 16) and day 23.
Measured: Baseline (day 16) and day 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start16 May 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Principal investigator, Mattias Lorentzon, Sahlgrenska University Hospital
- Investigators
- Mattias Lorentzon, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767711
- Sponsor's protocol ID
- GCreuteri
- Status last verified
- Feb 2023
- First submitted
- 12 Feb 2021
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nilsson AG, Sundh D, Backhed F, Lorentzon M. Lactobacillus reuteri reduces bone loss in older women with low bone mineral density: a randomized, placebo-controlled, double-blind, clinical trial. J Intern Med. 2018 Sep;284(3):307-317. doi: 10.1111/joim.12805. Epub 2018 Jul 22.
PubMed 29926979Gregori G, Johansson L, Silberberg L, Imberg H, Magnusson P, Lind M, Lorentzon M. Prevention of glucocorticoid-induced impairment of bone metabolism-a randomized, placebo-controlled, single centre proof-of-concept clinical trial. JBMR Plus. 2025 Feb 17;9(4):ziaf031. doi: 10.1093/jbmrpl/ziaf031. eCollection 2025 Apr.
PubMed 40162303
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Glucocorticoid Induced Impairment of Bone Metabolism - A Randomized, Placebo-Controlled, Single Centre Clinical Trial
- ClinicalTrials.gov ID
- NCT04767711
- Acronym / sponsor ID
- GCreuteri
- Conditions
- Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- 16 May 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
By advertising in newspapers, in shops, health clubs, in public places, and on social media platforms, and by contacting interested persons (by mail and phone) identified publicly available websites (e.g. www.ratsit.se), 46 young, healthy men and women will be recruited, to participate in the study. Study subjects will be contacted by phone and receive more information regarding the study and undergo a preliminary evaluation about eligibility to participate. Detailed study information will be sent by mail to study subjects. At the screening visit, participants will receive information about the study verbally, and if participants sign the informed consent form, participants will undergo a test of fasting blood glucose, HbA1c, and an oral glucose tolerance test (OGTT). A standardized self-reported questionnaire will be used to collect information at the screening visit about smoking habits, calcium intake, medical history, medications, previous fractures, physical activity, and diet habits. Eligible participants are then invited to the randomization visit. At the randomization visit, the study subjects will be asked to refrain from physical exercise, other than walking and keep an unchanged normal diet from study day 14. Randomization will be carried out by the supplier of LR (BioGaiaAB). The investigators will not have access to the randomization code and blinding will be maintained until study end and database lock. After randomization, study participants will consume either LR or placebo for 30 days. After the 14-day run-in period, all participants will start taking 25 mg of oral prednisolone every morning for 7 days. At the 14-day visit, a 24-hour glucose monitoring for the following 10 days will be started. At the next visit on day 16, fasting blood samples will be drawn in the morning (7-9 am), feces samples provided (within 24 hours of collection) and participants will start the oral GC treatment on that visit after blood samples have been drawn. At the 19-, 23- and 30-day visits, blood samples will be drawn in the morning (7-9 am for all visits, prior to taking the GC dose). Feces samples will also be collected at these visits. Included participants will be asked to come to the clinic and report compliance and possible adverse events during the duration of the study and at all visits.
Analyses.
Questionnaires:
A standardized questionnaire will be used to collect information at the screening visit about smoking habits, calcium intake, medical history (e.g. stroke, rheumatoid arthritis, and diabetes), medications, and previous fractures. Current physical activity and diet habits will be assessed by self-reported questionnaires (IPAQ and FFQ) at baseline. Daily intake of calcium will be calculated from the questionnaires about calcium-containing foods (e.g. dairy products, vegetables etc). Gastrointestinal symptoms will be analyzed using the GSRS questionnaire.
Serum, plasma, and stool analyses:
Serum and plasma will be collected in the morning (fasting), frozen, and stored at -80° C until further analyses. Samples from day 16 will be drawn prior to oral GC treatment start. A maximum of 30 ml of blood will be collected at each visit. Fasting blood glucose will be analyzed using fresh blood at screening (with the addition of HbA1c at screening), and days 16 (GC start), 19, 23, and 30. Serum and plasma samples will be frozen immediately and kept until analysis. Analyses of serum or plasma and bone markers (osteocalcin, P1NP, and CTX) will be performed using commercially available immunosorbent assays. Stool samples will be collected within 24 hours since produced and stored at -80oC until further analysis.
Oral glucose tolerance test (OGTT):
At the screening visit, a morning fasting blood glucose will be measured, followed by ingestion of 24 cl of glucose syrup, containing 75 grams of sugar. After 2 hours another blood glucose measurement will be performed. Inclusion in the study will depend on having a normal fasting blood glucose (≤6 mmol/l) and OGTT (<7.8 mmol/l).
Markers of intestinal permeability and intestinal inflammation:
Analyses of markers for intestinal permeability (endotoxin analysis, PyroGeneTM Recombinant Factor C Endpoint Fluorescent Assay) will be performed using a fluorescent assay at day 16, day 19, and day 23. Markers of intestinal inflammation (lipocalin-2 and calprotectin) will also be analyzed in feces and serum.
Analyses of gut microbiota - exploratory analyses:
DNA from feces samples will be isolated using a well-validated protocol and perform PCR to amplify the variable regions (V4) of the bacterial 16S rRNA gene using barcoded primers. Metagenome analyses of all samples will also be performed.
Continuous glucose monitoring:
On study day 14, continuous glucose monitoring (CGM) will be started, allowing a 48-hour observation period prior to commencement of oral prednisolone dosing. CGM will be used from day 14 until prednisolone treatment cessation on day 23. The Dexcom G6 system will be used for CGM on all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri | Active comparator | Dietary Supplement: Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475), Drug: PrednisoloneCapsules of freeze-dried L. reuteri 6475 of 5x10E9 colony-forming units (CFU) mixed with maltodextrin powder and 200 IU of cholecalciferol, taken twice daily for 30 days, yielding a total daily dose of 1x10E10 L.reuteri CFU and 400 IU of cholecalciferol per day. Oral glucocorticoid 25 mg daily for 7 days. |
| Placebo | Placebo comparator | Drug: PrednisolonePlacebo product identical to the active product (L. reuteri) in taste and appearance but without the active component, orally twice daily, for 30 days.The placebo product contains 200 IU cholecalciferol per dose, yielding a total dose of cholecalciferol of 400 IU per day. Oral glucocorticoid 25 mg daily for 7 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
- Vaccinated for Covid-19
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)L.reuteri with cholecalciferol compared to cholecalciferol only. | Dietary supplement | L. reuteri |
| PrednisoloneOral glucocorticoid 25 mg daily for 7 days. | Drug | L. reuteri, Placebo |
Primary outcome
Change in bone turnover marker serum osteocalcin
Time frame: Baseline (day 16) to day 23
Between group percent change in bone turnover markers osteocalcin between baseline (day 16, prior to GC treatment start) and day 23 (7 days after starting oral GC).
Change in bone turnover marker serum PINP
Time frame: Baseline (day 16) to day 23
Between group percent change in bone turnover markers serum PINP between baseline (day 16, prior to GC treatment start) and day 23 (7 days after starting oral GC).
Change in bone turnover marker serum CTX
Time frame: Baseline (day 16) to day 23
Between group per cent change in bone turnover marker serum CTX between baseline (day 16, prior to GC treatment start) and day 23 (7 days after starting oral GC).
7 secondary outcomes
Change in blood glucose levels
Time frame: Day 14-16 to day 16-23
Change in serum marker of intestinal permeability - endotoxin levels
Time frame: Baseline (day 16) to day 23
Change in feces marker lipocalin-2 of intestinal inflammation
Time frame: Baseline (day 16) and day 23
Change in feces marker calprotectin of intestinal inflammation
Time frame: Baseline (day 16) and day 23
Change in serum marker lipocalin-2 of intestinal inflammation
Time frame: Baseline (day 16) and day 23
Change in serum marker calprotectin of intestinal inflammation
Time frame: Baseline (day 16) and day 23
Change in the gut microbiota composition
Time frame: Baseline (day 16) and day 23
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Background: PubMed 29926979Nilsson AG, Sundh D, Backhed F, Lorentzon M. Lactobacillus reuteri reduces bone loss in older women with low bone mineral density: a randomized, placebo-controlled, double-blind, clinical trial. J Intern Med. 2018 Sep;284(3):307-317. doi: 10.1111/joim.12805. Epub 2018 Jul 22.
- Derived from this study: PubMed 40162303Gregori G, Johansson L, Silberberg L, Imberg H, Magnusson P, Lind M, Lorentzon M. Prevention of glucocorticoid-induced impairment of bone metabolism-a randomized, placebo-controlled, single centre proof-of-concept clinical trial. JBMR Plus. 2025 Feb 17;9(4):ziaf031. doi: 10.1093/jbmrpl/ziaf031. eCollection 2025 Apr.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mattias Lorentzon, MD, PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475) and Prednisolone in people with Bone Loss, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bone turnover marker serum osteocalcin (time frame: Baseline (day 16) to day 23). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767711, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.