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    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    EudraCT Number:2019-004208-37
    Sponsor's Protocol Code Number:S63190
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-03-04
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-004208-37
    A.3Full title of the trial
    Drug repurposing - Statins as microbiota modulating agents in ulcerative colitis
    Hergebruik van geneesmiddelen - Statines als microbiota-modulerende middelen bij colitis ulcerosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Statins for treating ulcerative colitis through GI microbiome
    Statines voor de behandeling van ulceratieve colitis door middel van GI-microbioom
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberS63190
    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 SponsorUZ Leuven
    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 supportFonds Wetenschappelijk Onderzoek - Vlaanderen (FWO)
    B.4.1Name of organisation providing supportVlaamse Instituut Biotechnologie
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKU Leuven
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address49 Herestraat
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    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. name Rosuvastatine EG
    D. of the Marketing Authorisation holderEurogenerics
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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.3.1Product namerosuvastatin
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrosuvastatin
    D.3.9.3Other descriptive nameROSUVASTATIN CALCIUM
    D.3.9.4EV Substance CodeSUB20721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    There are two population groups, 20 healthy volunteers and at least 165 individuals diagnosed with IBD. Either with remission to mild/moderate active ulcerative colitis or remission to mild Crohn's disease.
    E.1.1.1Medical condition in easily understood language
    A bowel disease that are characterized by inflammation with ulcer formation in the lining of large intestine (UC) and/or rest of intestines (CD). Characterized by diarrhea and abdominal cramps.

    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    • Evaluation of the microbiota modulation away from inflammation associated microbiota profile Bacteroides2 (Bact2)
    • Evaluation of the microbiota modulation potential of statins in Bact2-enterotyped, healthy volunteers and inflammatory bowel disease patients.
    E.2.2Secondary objectives of the trial
    • Evaluation of the effect of microbiota modulation on disease activity in ulcerative colitis and Crohn's disease patients.
    • Evaluation of reduced inflammatory parameters of participants involved in trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General criteria
    •Willingness to participate in the study and to sign the informed consent (Dutch)
    •Between 18 and 75 years old
    •Access to a -20°C freezer
    Criteria specific to UC patients
    •Patients in remission (mayo score below 4) or with currently mild to moderate active ulcerative colitis (defined by Mayo score of 4-10), despite stable medication (8 weeks) and a Mayo endoscopic sub-score 2-3 at week 0
    Criteria specific to healthy Bact2 participants
    •Individuals with no physician diagnosed diseases or disorders
    Criteria specific to CD patients
    • Patients in clinical remission (CDAI score below 150 at week 0) or with currently mild active Crohn’s disease (CDAI score between 150–220 at week 0), despite stable medication

    E.4Principal exclusion criteria
    General criteria
    • Prior and/or ongoing use of statins before study start
    • History of surgical intervention in gastrointestinal tract (appendectomies are allowed)
    • Females who are pregnant or actively trying to become pregnant
    • Individuals with active liver disease including unexplained persistent elevations of serum transaminases and any serum transaminases elevation exceeding three times the upper limit of normal (ULN)
    • Lactose intolerance
    • Pre-diabetic participants
    • Personal or family history of hereditary muscular disorders
    • Individuals with a history of or diagnosed with alcohol abuse

    Criteria specific to UC patients
    • Other conditions leading to profound immunosuppression such as HIV, infectious diseases leading to immunosuppression, bone marrow malignancies, liver cirrhosis
    • A diagnosis of indeterminate colitis
    • Individuals with hypothyroidism
    • Individuals with a diagnosis of diabetes mellitus
    • Individuals with severe renal impairment (creatinine clearance <30 ml/min)
    • Individuals with myopathy
    • Participants who have taken antibiotics sometime in the past four months
    • Use of antibiotics one month prior to week 0
    • Steroid dependency and requiring >16mg Medrol (methyl prednisone) or equivalent two week before week 0
    Criteria specific to healthy Bact2 participants
    • Participants with family history of autoimmune chronic inflammatory diseases like multiple sclerosis, IBD, and rheumatoid arthritis
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the trial is modulate at least 15% of those with Bact2 enterotype to a different enterotype and breaking the inflammatory cycle between the IBD and pro-inflammatory microbes.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Either at study site visit after the first period (week 8 + or - 3 days) or the second period (week 16 + or - 3 days) of intervention is complete. This depends whether the participant was randomized into the placebo or IMP first arms.
    E.5.2Secondary end point(s)
    To ensure that a significant number of ulcerative colitis participants improved in their disease state, a reduction of at least 1 point in their mayo endoscopic sub score and/or a general 3-point reduction of their total Mayo score. For Crohn’s disease patients, a significant improvement is characterized by a 70-point reduction in the Crohn’s disease activity index (CDAI) or a CDAI score < 150 points Inflammatory status local (faecal calprotectin) and systemically (hs-CRP) will be closely assessed in addition to other health parameters. Time point comparisons of these variables will be conducted with paired Wilcoxon tests with multiple testing correction. Mental outlook and response to treatment versus outlook with placebo, characterized by the RAND-36 in questionnaires will be conducted with fisher exact tests. Other lifestyle habits and alterations will be documented with questionnaires and used to account for confounders in the analyses.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints at study site visit after the first period (week 8 + or - 3 days) or the second period (week 16 + or - 3 days) of intervention is complete when the IBD patient enters the study site for their evaluation.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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 Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    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)
    No additional treatment plans will be included.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-03
    P. End of Trial
    P.End of Trial StatusOngoing
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