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    Summary
    EudraCT Number:2021-000275-36
    Sponsor's Protocol Code Number:CSUB0202
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-07
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2021-000275-36
    A.3Full title of the trial
    Prevention of Glucocorticoid induced impairment of bone metabolism – A Randomized, Placebo-Controlled, Single Centre Clinical Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of Glucocorticoid induced impairment of bone metabolism – A Randomized, Placebo-Controlled, Single Centre Clinical Trial
    A.4.1Sponsor's protocol code numberCSUB0202
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04767711
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSahlgrenska University Hospital
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBioGaia AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska UNiversity Hospital
    B.5.2Functional name of contact pointMattias Lorentzon
    B.5.3 Address:
    B.5.3.1Street AddressGöteborgsvägen 31
    B.5.3.2Town/ cityMölndal
    B.5.3.3Post code431 80
    B.5.3.4CountrySweden
    B.5.6E-mailmattias.lorentzon@medic.gu.se
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Prednisolon Alternova
    D.2.1.1.2Name of the Marketing Authorisation holderOrifarm Generics AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    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.
    E.1.1.1Medical condition in easily understood language
    The aim of this trial is to investigate if daily supplementation with Lactobacillus reuteri, can prevent the negative effects of oral glucocorticoid on bone turnover in healthy young adults.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary outcome: between group per cent change in bone turnover markers between baseline (day 16, prior to GC treatment start) and day 23 (7 days after starting oral GC).
    1. Serum osteocalcin
    2. Serum CTX
    3. Serum P1NP
    E.2.2Secondary objectives of the trial
    1. Change in blood glucose levels (area under the curve) using continuous glucose monitoring (CGM) between baseline (day 14-16) and days 16-23.
    2. Change between baseline (day 16) and day 23 in serum markers of intestinal permeability (endotoxin levels).
    3. Change between baseline (day 16) and day 23 in serum and feces markers of intestinal inflammation (lipocalin-2 and calprotectin)
    4. Change in the gut microbiota composition between baseline (day 16) and day 23.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome: between group per cent change in bone turnover markers between baseline (day 16, prior to GC treatment start) and day 23 (7 days after starting oral GC).
    1. Serum osteocalcin
    2. Serum CTX
    3. Serum P1NP
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between the day with glucocorticoid (GC) treatment start and 7 days after starting oral GC.
    E.5.2Secondary end point(s)
    1. Change in blood glucose levels (area under the curve) using continuous glucose monitoring (CGM) between baseline (day 14-16) and days 16-23.
    2. Change between baseline (day 16) and day 23 in serum markers of intestinal permeability (endotoxin levels).
    3. Change between baseline (day 16) and day 23 in serum and feces markers of intestinal inflammation (lipocalin-2 and calprotectin)
    4. Change in the gut microbiota composition between baseline (day 16) and day 23.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between baseline (day 14-16) and days 16-23.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Adverse events are followed up for a month after end of the study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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