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    Summary
    EudraCT Number:2018-001203-36
    Sponsor's Protocol Code Number:BHT-II-002
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-04-10
    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 ConcernedIreland - HPRA
    A.2EudraCT number2018-001203-36
    A.3Full title of the trial
    A Phase 2 Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Study to Evaluate the Safety and Efficacy of Repeated Oral Doses of Blautix™ in Adult Subjects with Irritable Bowel Syndrome (IBS) Subtypes IBS-C and IBS-D
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety and effectiveness of Blautix™ in adults with Irritable Bowel Syndrome (IBS)
    A.4.1Sponsor's protocol code numberBHT-II-002
    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 Sponsor4D Pharma Plc
    B.1.3.4CountryUnited Kingdom
    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 support4D Pharma Plc
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation4D Pharma Plc
    B.5.2Functional name of contact pointClinical Trials Department
    B.5.3 Address:
    B.5.3.1Street Address9 Bond Court
    B.5.3.2Town/ cityLeeds
    B.5.3.3Post codeLS1 2JZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number440113895 0130
    B.5.6E-mailclinicaltrials@4dpharmaplc.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 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 nameBlautix
    D.3.2Product code MRx1234
    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 INNNot available
    D.3.9.1CAS number Not availabl
    D.3.9.2Current sponsor codeMRx1234
    D.3.9.3Other descriptive nameBlautia hydrogenotrophica, DSMZ nº14294
    D.3.10 Strength
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5E+9 MPN/capsule to 5E+10 MPN/capsule
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    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
    Irritable Bowel Syndrome (IBS), subtypes IBS-C and IBS-D
    E.1.1.1Medical condition in easily understood language
    Irritable Bowel Syndrome, which is a chronic bowel disease that can affect any part of the gastrointestinal tract
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10060849
    E.1.2Term Diarrhoea predominant irritable bowel syndrome
    E.1.2System Organ Class 100000004856
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066868
    E.1.2Term Constipation predominant irritable bowel syndrome
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to assess the efficacy of repeated twice daily doses of Blautix™ >1E10 MPN for 8 weeks in adult subjects with either IBS-C or IBS-D
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial is to assess the safety of repeated twice daily doses of Blautix™ >1E10MPN for 8 weeks in adult subjects with either IBS-C or IBS-D
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects must meet all of the following inclusion criteria:
    1. Written consent on an Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved ICF before any study specific evaluation
    2. Males and Females between 18 and 70 years of age
    3. Body Mass Index (BMI): 18-39 kg/m2
    4. Having IBS-C or IBS-D as defined by Rome IV including Subtype Classification:
    Recurrent abdominal pain on average, at least 1 day/week in the last 3 months associated with two or more of the following criteria:
    • Related to defecation
    • Associated with a change in frequency of stool
    • Associated with a change in form (appearance) of stool
    The above criteria must be met for the last 3 months with symptom onset at least 6 months prior to diagnosis.
    5. Have a moderate or severe IBS symptom severity score ; ≥175 at the screening visit as defined by IBS-SSS. A tolerance of -10% (≥ an IBS-SSS score of 157.5) will be allowable at the Baseline (Visit 1).
    E.4Principal exclusion criteria
    Any of the following criteria will exclude the Subject from study participation:
    1. Males or females <18 and >70 years of age
    2. Have an IBS symptom severity score < 175 as defined by IBS-SSS
    3. BMI: <18 or >39 kg/m2
    4. Have a significant acute or chronic coexisting illness (cardiovascular, gastrointestinal, endocrine, immunological, metabolic or any condition which contraindicates, in the investigators' judgment, entry to the study)
    5. Confirmed clinical diagnosis of bile acid malabsorption and / or on medication for bile acid malabsorption
    6. Individuals who, in the opinion of the investigator, are poor attendees or unlikely for any reason to be able to comply with the study requirements
    7. Patient is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or patient is receiving other investigational agent(s)
    8. Have an active or recent (within 3 years) malignant disease or any concomitant end-stage organ disease. A non-melanoma skin cancer that has been adequately treated with no recurrence within 3 months of screening is not excluded.
    9. Females who are pregnant or breast feeding
    10. Refusal to use acceptable methods of birth control (true abstinence, sterilisation, birth control pills, injections or contraceptive implants) for women of child bearing potential while on treatment and following completion of 2 menstrual cycles/ months after the last dose of study treatment. For Males, a barrier method of birth control from randomisation until the Follow-Up visit, unless vasectomised
    11. Use of antibiotics within 30 days of screening
    12. Use of systemic steroids within 30 days of screening
    13. Change in dose or introduction of an antipsychotic within the last month
    14. Have suffered from an uncontrolled or current major psychiatric disorder
    15. Clinically diagnosed Lactose intolerance
    16. Clinically diagnosed Coeliac disease
    17. Change of diet e.g. FODMAP, gluten-free within last 3 months
    18. Those > 50 will be excluded if their diagnosis of IBS is recent (<12 months) and if they have not had a sigmoidoscopy or colonoscopy within previous 5 years.
    19. Any GI related abdominal surgery other than hernia repair or appendectomy. Cholecystectomy more than 6 months previously is not an exclusion
    20. Subjects taking prucalopride
    21. Known HIV infection, or hepatitis A, B, or C active infection
    22. Subjects with abnormal laboratory values at screening deemed by the investigator to be clinically significant
    23. Subjects who have taken commercially available probiotics within the last month (30 days prior to randomisation)
    24. Subjects with known or suspected hereditary fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
    25. Subjects taking guanylate cyclase agonists; such as linaclotide and lubiprostone
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is whether the subject is an overall responder.
    A subject is an 'overall responder' if they have reported an improvement in their weekly (Cohort specific) symptoms (abdominal pain intensity and stool frequency or consistency) for > 50% of the treatment period (in this case 4 out of 8 weeks).
    E.5.1.1Timepoint(s) of evaluation of this end point
    On-going throughout the 8 week duration of the study
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    - Subject global assessment of relief
    - Stool consistency /Stool frequency
    - IBS-QOL
    - IBS-SSS
    - HADS
    Exploratory Endpoints
    - Microbiota diversity and stability
    - Metabolomics
    - Cytokine analysis
    Safety Endpoints
    - Incidence, nature, severity, relatedness, seriousness, expectedness and outcome of adverse events
    - Haematology and blood chemistry assessments
    - Vital signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    On-going throughout the 8 week duration of the study
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.5Parallel group Yes
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Ireland
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 118
    F.4.2.2In the whole clinical trial 340
    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)
    Routine clinical IBS care will run in parallel to study participation, then after the study has finished care will continue for each subject as normal.
    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 Decision2018-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-15
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