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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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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    Summary
    EudraCT Number:2014-005666-29
    Sponsor's Protocol Code Number:Theta001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-11
    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 ConcernedUK - MHRA
    A.2EudraCT number2014-005666-29
    A.3Full title of the trial
    A Phase 1 randomised, double-blind, placebo-controlled study to assess the safety and tolerability of Bacteroides thetaiotaomicron in young people aged 16 to 18 years with stable Crohn's disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate Thetanix (Bacteroides thetaiotaomicron) in young people aged 16 to 18 years with stable Crohn's disease
    A.3.2Name or abbreviated title of the trial where available
    A study of Thetanix in young people with stable Crohn's disease
    A.4.1Sponsor's protocol code numberTheta001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02704728
    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
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAscot Research Consulting
    B.5.2Functional name of contact pointStudy management
    B.5.3 Address:
    B.5.3.1Street Address105 Sutherland Chase
    B.5.3.2Town/ cityAscot
    B.5.3.3Post codeSL5 8TE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01344622227
    B.5.6E-mailmarion@ascotrc.co.uk
    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 nameThetanix
    D.3.2Product code B. theta
    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 INNColony-purified Bacteroides thetaiotaomicron (B.theta)
    D.3.9.2Current sponsor codeMRx1233 (previously LBP001)
    D.3.9.3Other descriptive nameB. theta
    D.3.9.4EV Substance CodeAS1
    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 number1E+7 to 1E+10 to CFU/g
    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
    Crohn's disease in young persons
    E.1.1.1Medical condition in easily understood language
    Crohn's disease which is a chronic, autoimmune inflammatory 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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 is to assess the tolerability and safety of B. theta when administered as a single dose and in multiple doses.
    E.2.2Secondary objectives of the trial
    The exploratory objective is to assess the effect of administering single and multiple doses of B. theta on the gastrointestinal microbiome and the effect of multiple doses on faecal calprotectin as a non-invasive test to obtain a marker of intestinal inflammation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects aged 16 to 18 years with confirmed diagnosis of Crohn's disease who are currently in clinical remission in the opinion of the Investigator, and who are otherwise healthy.
    2. Subjects who are able and willing to give written informed consent to participate.
    Remission is defined as:
    Physician's global assessment that subject is in remission; Weighted Paediatric Crohn's Disease Activity Index (wPCDAI) less than or equal to 12.5; no clinically significant, in the opinion of the Investigator, elevations of platelets, white cell count, C-reactive protein or ESR and no clinically significant decrease in albumin or haemoglobin.
    E.4Principal exclusion criteria
    1. Subjects who are pregnant or breastfeeding
    2. Subjects who are experiencing an exacerbation at the time of screening or up to the time of the first dose.
    3. Subjects who have undergone surgery for resection of bowel in the last 12 months or subjects who have undergone resection of bowel more than 12 months ago, and have experienced an exacerbation in the last 12 months or developed fistulae. (Subjects who have had resection of bowel more than 12 months ago, with no further requirement for surgery within the last 12 months, with stable medications as per other inclusion/exclusion criteria; and subjects who have surgery for perianal abscess more than 6 months prior to dosing remain eligible.)
    4. Subjects who have fistulisation.
    5. Subjects who have a significant change in their immune-modulating maintenance in the 3 months prior to screening and/or the start of dosing.
    6. Subjects who have taken systemic steroids in the last 3 months (rectal and inhaled steroid use is permitted.)
    7. Subjects who are unable to take any oral feeding.
    8. Subjects with feeding gastrostomies.
    9. Subjects who have non-food dietary supplementation for any reason changed within 1 month prior to dosing.
    10. Subjects who are receiving a dose of monoclonal antibodies that has required adjustment, due to clinical indications relating to their underlying CD, and therefore has not been within a stable dosing range (e.g. 5mg/kg 8 weekly, allowing for changes in patient weight) for the past 12 months, or who have evidence of an exacerbation. (Note: subjects who have missed doses of monoclonal antibodies due to intercurrent illness unavailability, exams, holidays, other extraneous or non-clinical reasons are eligible).
    11. Subjects who have received antibiotics or probiotic dietary supplementation in the two weeks before dosing. Subjects who have received foods with probiotics e.g. yoghurts will be permitted to volunteer for the study.
    12. Subjects who are receiving exclusive enteral feeding or have completed a course of exclusive enteral feeding in the 3 months prior to dosing.
    13. Subjects with concomitant autoimmune diseases (e.g. Type 1 diabetes, juvenile arthritis, psoriasis).
    14. Female subjects of child bearing potential unwilling to use effective contraception. An effective method of birth control is defined as one which results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilisation, implants, injectables, combined oral contraceptives, IUDs (Intrauterine device), condoms, occlusive caps (cervical/vault caps) with spermicidal foam/gel/film/cream/pessary. True sexual abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence e.g. calendar, ovulation, symptothermal, post-ovulation methods, declaration of abstinence for the duration of the trial and withdrawal are not acceptable methods of contraception).
    15. Subjects with clinically significant, in the opinion of the Investigator, elevated platelets, white cell count, C-reactive protein, ESR, low albumin or haemoglobin.
    16. Subjects who are positive for the following viruses: HIV, hepatitis B and hepatitis C.
    17. Subjects who smoke cigarettes or use other tobacco or nicotine containing products, including e-cigarettes.
    18. Subjects who have a known sensitivity to any of the constituents of the investigational medicinal product.
    19. Diastolic blood pressure less than 50 or greater than 90 mmHg, a systolic blood pressure less than 100 or greater than 150 mmHg, a pulse less than 40 or greater than 100 beats per minute after resting for 5 minutes.
    20. Subjects with clinically significant abnormal ECGs or structural cardiac abnormalities e.g. valvular heart disease, patent foramen ovale.
    21. BMI Z score less than -2.6 or greater than 2.6 i.e. below the 2nd centile or greater than the 98th centile.
    22. Any condition that, in the opinion of the Investigator, might interfere with the primary study objective.
    23. Subjects allergic to both metronidazole and co-amoxiclav.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the incidence of adverse events assessed by treatment,severity and relationship to study medication.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events will be assessed:
    Part A: Day 0 (day of dosing) pre-dose, 2, 4 and 8 hours post dose; Day 1 (24 hours post-dose) and Day 7.
    Part B: Day 0 pre, 2 and 4 hours post-first dose; Day 1, Day 7 pre, 2 and 4 hours post last dose, Day 14 and Day 56.
    In addition, subjects will be required to complete an electronic diary to record adverse events and body temperature.
    E.5.2Secondary end point(s)
    Secondary Safety measures: laboratory safety tests, physical examination, vital signs (blood pressure, pulse rate, respiratory rate, oral temperature), 12 lead ECG, BMI Z-score (Part B only), physician global assessment; weighted Paediatric Crohn's Disease Activity Index (wPCDAI). Blood cultures if clinically indicated due to fever.
    Exploratory: Microbiome constituents and faecal calprotectin concentrations.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Lab safety tests: screen, Day 1; Day 7, Day 56
    Physical examination: screen, Day 0, Day 7, Day 56
    Vital signs: screen, Day 0, Day 1, Day 7, Day 14, Day 56
    12 lead ECG: screen, Day 7
    BMI Z score : screen, Day 0, Day 7, Day 14, Day 56
    Physician global assessment: screen,Day 0, Day 7, Day 56
    wPCDAI: screen, Day 0, Day 1, Day 7, Day 14, Day 56
    Exploratory evaluations: Day 0;Day 1, Day 7, Day 56
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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) 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 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 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 concerned5
    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 years2
    E.8.9.1In the Member State concerned months6
    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 months6
    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 Yes
    F.1.1Number of subjects for this age range: 18
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state18
    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 IBD 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
    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 Decision2015-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-04-10
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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