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    Summary
    EudraCT Number:2016-001240-19
    Sponsor's Protocol Code Number:CSL16001
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-20
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2016-001240-19
    A.3Full title of the trial
    Clearance of the probiotic strain Escherichia coli Nissle 1917 in the gastrointestinal tract of healthy volunteers
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clearance of the probiotic strain Escherichia coli Nissle 1917 in the gastrointestinal tract of healthy volunteers
    A.4.1Sponsor's protocol code numberCSL16001
    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 SponsorSynlogic
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSynlogic
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSynlogic
    B.5.2Functional name of contact pointSarah Guilmain
    B.5.3 Address:
    B.5.3.1Street Address200 Sidney Street, Suite 320
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16175006635417
    B.5.6E-mailsarahg@synlogictx.com
    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 Mutaflor
    D.2.1.1.2Name of the Marketing Authorisation holderArdeypharm GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Capsule
    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 INNESCHERICHIA COLI NISSLE 1917
    D.3.9.3Other descriptive nameESCHERICHIA COLI STRAIN NISSLE 1917
    D.3.9.4EV Substance CodeSUB76233
    D.3.10 Strength
    D.3.10.1Concentration unit CFU/g colony forming unit(s)/gram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.5 to 25
    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 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
    Healthy volunteers trial, intended indication: Colitis ulcerosa in phase of remission, Chronic constipation
    E.1.1.1Medical condition in easily understood language
    Colitis ulcerosa in phase of remission, Chronic constipation
    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
    To assess the clearance of Escherichia coli strain Nissle 1917 in the gastrointestinal tract after administration of an oral test preparation containing 2.5-25 x 10^9 CFU (Test IMP: Mutaflor® capsules) after single or multiple dose administrations of one capsule three times daily for 28 days (48 volunteers) or for 1 day (10 volunteers) taken together with meals
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. No pre-existing medical conditions based on medical history and physical examination
    2. Non-smoking
    3. Male and female volunteers, aged 18-55 years
    4. Normal weight according to the BMI (accepted range 18.5 to 30.0 kg/m2)
    5. Regular bowel habits including consistency, frequency (4-14 stools per week)
    6. Willingness to commit to no major dietary changes to daily carbohydrate and protein intake during the trial and until 2 weeks after last administration
    7. Negative pregnancy test for all females of childbearing potential at entry visit
    8. Signed written informed consent by subject
    E.4Principal exclusion criteria
    1. Use of Mutaflor (or any other probiotic product) within 12 months prior to study initiation
    2. Use of any investigational drug or antibiotics within 60 days prior to study initiation
    3. Baseline EcN positivity by PCR assay of stool sample
    4. Active infection (viral or bacterial)
    5. Active GI disease (current or within past 6 months) including nausea, vomiting, diarrhea, constipation, abdominal pain, malabsorption, GI bleeding, inflammatory bowel disease, or any other condition that could affect Mutaflor passage or activity in the GI tract or cause fluctuations in GI signs/symptoms
    6. Any previously diagnosed inflammatory bowel disease or irritable bowel syndrome
    7. Major surgery of the gastrointestinal tract except for appendectomy
    8. History of immune-compromised condition (e.g., AIDS, lymphoma, subjects undergoing corticosteroid treatment)
    9. Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), and/or hepatitis C virus (HCV) antibodies
    10. Hypersensitivity to the active substance in Mutaflor or to any of the excipients
    11. Allergic diathesis or any clinically significant allergic disease (i.e. asthma or bronchial hyperreactivity)
    12. Laboratory values outside the normal range that are determined to be clinically significant by the investigator
    13. Other severe chronic medical conditions or other active diseases that should be excluded, based on clinical assessment of the investigator
    14. Systolic blood pressure outside the range of 100 to 140 mmHg and/or diastolic blood pressure outside the range of 60 to 90 mmHg at entry visit
    15. Heart rate outside the range of 50 to 90 beats/min at entry visit
    16. Body temperature (axillary) outside the interval of 35.5 to 37.1°C at entry visit
    17. Any clinically significant abnormality of the resting ECG (12-lead) (i.e. AV block, 2° to 3°, sinus bradycardia, sick sinus syndrome, SA block)
    18. Special diet due to any reason, e.g. vegetarians
    19. Subjects expected not to be able to fulfil study specific restrictions given in chapter 9.4 Restrictions of the study protocol
    20. Pregnant and/or nursing women. Positive pregnancy test on day 0
    21. Fertile women without reliable contraception method.
    List of medically accepted contraceptive methods (used at least 4 weeks prior entry visit and not to be changed for the duration of the study):
    a. combination of 2 barrier methods: female/male condoms, diaphragms, spermicides
    b. hormonal methods: combined estrogen/progestin injectable and oral contraceptives, progestin injectable and oral contraceptives, Norplant implants, skin patches, NuvaRing®
    c. intrauterine devices (IUD): inert or copper-releasing or progestin-releasing IUD
    d. voluntary sterilization (female tubal occlusion)
    22. History of drug abuse or use of illegal drugs: use of soft drugs, e.g. marihuana within 6 months of screening or hard drugs, e.g. cocaine, amphetamines, phencyclidine within 1 year of screening
    23. Alcohol abuse, i.e. regular use of more than 2 units of alcohol per day or 10 units per week or a history of alcoholism (one unit of alcohol equals 250 ml beer, 125 ml wine or 25 ml spirits) or recovered alcoholics
    24. Positive drug screening and/or positive alcohol test at entry screening or on day 0
    25. Subjects who are known or suspected:
    a. not to comply with the study directives
    b. not to be capable of understanding and evaluating the information given to them as part of the formal information policy (informed consent), in particular regarding the risks and discomfort to which they would agree to be exposed
    c. to be in such a precarious financial situation that they no longer weigh up the possible risks of their participation and the unpleasantness they may be involved in
    E.5 End points
    E.5.1Primary end point(s)
    1. Percentage of volunteers with a stool sample positive for Escherichia coli strain Nissle 1917, 24 weeks after the start of treatment;
    2. Time to no detection of EcN in the stool
    E.5.1.1Timepoint(s) of evaluation of this end point
    After completion of the clinical part of the trial and database lock
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 No
    E.6.4Safety Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    clearance of Escherichia coli strain Nissle 1917 in the gastrointestinal tract, assessment of changes in GI symptoms
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 years1
    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: 58
    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 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 state58
    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)
    None
    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 Decision2016-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-19
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