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    Summary
    EudraCT Number:2020-000228-20
    Sponsor's Protocol Code Number:16012020001
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-31
    Trial 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 ConcernedAustria - BASG
    A.2EudraCT number2020-000228-20
    A.3Full title of the trial
    Probiotic dietary Intervention in Polycystic Ovary Syndrome – A Randomized Controlled Trial
    Probiotische Interventionsstudie bei Polyzystischem Ovarsyndrom (PCOS) - eine randomisiert kontrollierte Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of ingesting gut bacteria in women with Polycystic Ovary Syndrome, a condition with elevated male sex hormones - a comparison between the supplement and a placebo and metformin, the standard therapy for the condition
    Der Effekt von zugeführten Darmbakterien in Frauen mit dem Polyzystischen Ovarsyndrom (PCOS), einer hormonellen Störung mit erhöhten männlichen Geschlechtshormonen - ein Vergleich zwischen dem Nahrungsergänzungsmittel, einem Placebo und Metformin, der Standardtherapie für PCOS
    A.3.2Name or abbreviated title of the trial where available
    ProPCO-RCT
    A.4.1Sponsor's protocol code number16012020001
    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 SponsorMedical University of Graz
    B.1.3.4CountryAustria
    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 supportMedical University of Graz
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportCenter for Biomarker Research
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportInstitute Allergosan
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportWinclove Probiotics
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointEndokrinologieambulanz
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 15
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number0043316385-12303
    B.5.6E-mailendo.ambulanz@klinikum-graz.at
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Glucophage
    D.2.1.1.2Name of the Marketing Authorisation holderMerck GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameMetformin
    D.3.2Product code A10BA02
    D.3.4Pharmaceutical form Film-coated 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 INNMETFORMIN HYDROCHLORIDE
    D.3.9.1CAS number 1115-70-4
    D.3.9.4EV Substance CodeSUB03200MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 2
    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 No
    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 nameWinclove 843
    D.3.2Product code 60077
    D.3.4Pharmaceutical form Powder and solvent for oral suspension
    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 INNEnterococcus faecium W54
    D.3.9.3Other descriptive nameENTEROCOCCUS FAECIUM
    D.3.9.4EV Substance CodeSUB13676MIG
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1200000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLactibacillus acidophilus W22
    D.3.9.1CAS number 68333-16-4
    D.3.9.3Other descriptive nameLACTOBACILLUS ACIDOPHILUS
    D.3.9.4EV Substance CodeSUB14308MIG
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1200000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLactobacillus casei W56
    D.3.9.3Other descriptive nameLACTOBACILLUS CASEI
    D.3.9.4EV Substance CodeSUB33691
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1200000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLactobacillus rhamnosus W71
    D.3.9.1CAS number L04001-00-0
    D.3.9.3Other descriptive nameLACTOBACILLUS RHAMNOSUS
    D.3.9.4EV Substance CodeSUB30311
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1200000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLactobacillus plantarum W21
    D.3.9.3Other descriptive nameLACTOBACILLUS PLANTARUM
    D.3.9.4EV Substance CodeSUB35051
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1200000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNlactobacillus salivarius W57
    D.3.9.3Other descriptive nameLACTOBACILLUS SALIVARIUS
    D.3.9.4EV Substance CodeSUB26481
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1200000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLactococcus lactis W58
    D.3.9.1CAS number 8001002-33-3
    D.3.9.3Other descriptive nameLACTOCOCCUS LACTIS
    D.3.9.4EV Substance CodeSUB15396MIG
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1200000000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVitamin D3
    D.3.9.3Other descriptive nameCHOLECALCIFEROL CONCENTRATE (POWDER FORM)
    D.3.9.4EV Substance CodeSUB37745
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeProbiotic dietary supplement
    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 placeboPowder and solvent for oral suspension
    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
    Polycystic Ovary Syndrome (PCOS) is a hormonal and metabolic disorder
    affecting up to 20 percent of women worldwide, depending on diagnostic
    criteria. A very common definition of PCOS based on the revised
    Rotterdam criteria includes at least two out of three symptoms:
    • Oligo-/Amenorrhea
    • Polycystic ovarian morphology (PCOM)
    • Clinical or biochemical hyperandrogenism
    Das Polyzystische Ovarsyndrom ist eine hormonelle und
    Stoffwechselerkrankung, die bis zu 20% aller Frauen weltweit betrifft.
    Die Diagnose von PCOS basiert auf mindestens zwei von drei möglichen
    Rotterdam Kriterien:
    • Oligo-/Amenorrhoe
    • Polyzystische Ovarien Morphologie (PCOM)
    • Klinischer oder biochemischer Hyperandrogenismus
    E.1.1.1Medical condition in easily understood language
    Polycystic Ovary Syndrome (PCOS) is a hormonal and metabolic
    disorder. Due to elevated male sex hormone levels, it can cause
    menstrual irregularities as well as excess hair growth
    Das Polyzystische Ovarsyndrom ist eine hormonelle und
    Stoffwechselerkrankung, bei der erhöhte männliche Geschlechtshormone
    einen unregelmäßigen Zyklus, mehr Haarwuchs verursachen
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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
    Our primary aim is to establish probiotics as a possible PCOS treatment
    option by showing a significant improvement of free testosterone levels
    in comparison to placebo after a 6-month intervention period.
    Unser primäres Ziel ist es, Probiotika als eine mögliche Therapie bei
    PCOS zu etablieren, indem wir zeigen, dass eine 6-monatige Intervention
    mit Probiotika statistisch signifikant besser ist als ein Placebo in der
    Reduktion von freiem Testosteron im Blut.
    E.2.2Secondary objectives of the trial
    Our secondary objectives are:
    to compare the secondary outcome parameters to placebo and show a
    significant improvement in the probiotic group
    to compare the ourcome parameters of the probiotic treatment to
    metformin
    Als sekundäre Ziele wollen wir:
    die Probiotikagruppe mit dem placebo vergleichen in Hinsicht auf die
    sekundären Endpunkte
    Die Probiotikagruppe mti der Metformingruppe vergleichen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Premenopausal women with PCOS aged 18 to 45 years meeting two
    out of three Rotterdam criteria: polycystic ovarian morphology,
    biochemical and/or clinical hyperandrogenism and oligo-/anovulation
     Signed informed consent form
    E.4Principal exclusion criteria
     Missing or withdrawn consent
     Hyperandrogenism of a cause other than PCOS (Cushing´s syndrome,
    hyperprolactinemia, adrenal tumours, congenital adrenal hyperplasia,
    rare genetic disorders)
     Pregnancy or nursing period (first 6 months after giving birth)
     Soy or other allergies with respect to study procedures
     Diabetes mellitus type 1
     Chronic inflammatory bowel disease, history of cancer in the
    gastrointestinal tract or acute gastrointestinal infection
     Any malignancies that required treatment within the last 3 years
    prior to study procedures
     Any other chronic disease requiring medical check-ups or hospital
    treatments at least once every three months (exception: diabetes
    mellitus type 2)
     Major surgery in the gastrointestinal tract (e.g. colectomy, gut
    segment excision with stoma surgery, Whipple´s surgery.) Surgical
    removal of the appendix and/or the gall bladder is NOT considered major
    surgery.
     Therapy with antidiabetic drugs (metformin, sulfonylureas, DPP-4
    inhibitors, GLP-1 analogs, SGLT-2 inhibitors, insulin variants) within the
    last six months prior to study procedures
     Therapy with proton pump inhibitors within the last six months prior
    to study procedures
     Therapy with hormonal contraceptives or systemic (oral) intake of
    steroids
     Oral or intravenous therapy with antibiotics less than three months
    before the onset of study procedures
     Alcohol and/or drug abuse
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is a change in serum free testosterone
    concentration in women with PCOS after a 6-month intervention with
    probiotics compared to placebo treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline, after 6 months intervention, and an additional 6 months (voluntary) follow-up
    E.5.2Secondary end point(s)
     Glucose metabolism (Oral glucose tolerance test)
     Other hormonal parameters of PCOS (AMH; androstenedione; FSH; LH; DHEAS; 17-OH-progesterone; 17-OH-estradiole;
    dihydrotestosterone, total testosterone)
     Hirsutism (modified Ferriman-Galway-score)
     Body weight (BMI; waist-to-hip-ratio)
     Gut permeability and inflammation (Functional sugar test; surrogate
    parameters: serum diaminooxydase; stool zonulin; calprotectin;
    lipopolysaccharide; soluble CD14; bacterial DNA)
     Gut lumen and mucosa microbiome composition and metagenomic
    profile (16S-RNA gene sequencing)
     Phytoestrogen production (soy challenge test; urine daidzein and
    equol concentrations)
     Quality of life (PCOS questionnaire; depression questionnaires; diet
    questionnaires)
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline, after 6 months intervention, and an additional 6 months (voluntary) follow-up
    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 No
    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.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 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 No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Probiotics vs. placebo is double-blinded, metformin is open-labelled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    metformin is our comparator; Our investogational product is a dietary supplement (probiotics)
    E.8.2.4Number of treatment arms in the trial3
    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 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
    last visit of the last subject undergoing the trial
    E.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 180
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-07-31. Yes
    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 state180
    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)
    Participants taking either probiotics or the probiotics placebo during
    the trial my receive another 6 months´ worth of probiotics and may
    additionally return after those 6 months for a follow-up visit.
    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 Decision2020-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-16
    P. End of Trial
    P.End of Trial StatusOngoing
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