Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-005753-12
    Sponsor's Protocol Code Number:RG_15-026
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-08-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-005753-12
    A.3Full title of the trial
    Prospective, open-label, randomised pilot study to assess two possible routes of Faecal Microbiota Transplant (FMT) delivery in patients with ulcerative colitis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study looking at faecal transplant as a treatment for ulcerative colitis, and the best way to use it in children and adults with the condition
    A.3.2Name or abbreviated title of the trial where available
    STOP-Colitis Pilot Trial
    A.4.1Sponsor's protocol code numberRG_15-026
    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 SponsorUniversity of Birmingham
    B.1.3.4CountryUnited Kingdom
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Birmingham, Institute of Applied Health Research
    B.5.2Functional name of contact pointDr Laura Magill
    B.5.3 Address:
    B.5.3.1Street AddressPublic Health Building
    B.5.3.2Town/ cityEdgbaston
    B.5.3.3Post codeB15 2TT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01214159105
    B.5.6E-maile.l.magill@bham.ac.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 nameFaecal Microbiota Transplant
    D.3.2Product code FMT
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasogastric use (Noncurrent)
    Gastroenteral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNfaecal matter
    D.3.9.4EV Substance CodeAS1
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative colitis for at least 3 months prior to trial entry
    E.1.1.1Medical condition in easily understood language
    A long-term condition, where the colon and rectum becomes inflamed.
    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
    The aim of the pilot is to determine the most effective route for administering FMT in terms of ease of administration and patient acceptability, i.e best way of giving FMT in UC (Stop-Go guidelines will be used to decide whether to proceed to the randomised controlled trial (RCT)) and to determine if a full RCT is possible.
    E.2.2Secondary objectives of the trial
    To see whether FMT by the NG route helps to heal the gut in patients with active UC;
    To see whether FMT by the colonic route helps to heal the gut in patients with How patients tolerate FMT and how safe it is.
    Whether patients accept FMT given through the NG tube
    Whether patienst accept FMT given directly in the COLON
    Which route of FMT delivery (if any) is suitable to investigate in the RCT.

    Effect on gut bacteria (microbiome) both in the gut and the colon after FMT
    Effect on levels of inflammation shown in the blood test (C-Reactive Protein) from FMT
    Effect on the biochemistry (calprotectin levels) of the patients stool sample from FMT

    Whether the diet of the donors plays a role in the effects of FMT
    Time from stool donation to treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Donors:
    1)Over 18 and under 50 years of age
    2)regular morning bowel habits, which can be classified as Bristol stool chart type 2-5
    3)normal BMI (over 18.5 and under 25)
    4) presently be non-smokers (not smoked for the past 12 months)
    5) provide written informed consent

    Patients:
    1)Confirmed UC for at least 3 months from date of screening
    2) Age 12-70 years
    3) Partial Mayo score of between 4 and 8 despite stable 5ASA+/- thiopurine, methotrexate or no treatment
    4) Rectal bleeding subscore >0
    5) Written, signed informed consent and/or assent to the study.
    E.4Principal exclusion criteria
    Donors:
    GI history of:
    - inflammatory bowel disease
    - irritable bowel syndrome, idiopathic chronic constipation or chronic diarrhoea
    - gastrointestinal malignancy or known polyposis
    -celiac disease
    - congenital or chronic liver disease
    - per rectal bleeding
    - major gastrointestinal surgery (eg gastric bypass)


    AUTOIMMUNE history of systemic autoimmunity including:
    - Connective tissue disease
    - Thyroid disease
    - Inflammatory arthritis
    - Psoriasis
    - Alopecia

    ATOPIC disease inc.
    - Asthma
    - Atopic dermatitis
    - Eczema
    - Eosinophilic disorders of the gastrointestinal tract

    CHRONIC PAIN history inc.
    - Chronic fatigue syndrome
    - Fibromyalgia

    CARDIOVASCULAR history of a cardiovascular or metabolic syndrome including:
    - Diabetes (type 1 or type 2)
    - High blood pressure
    - High cholesterol
    - High fasting glucose
    - Heart disease (eg atherosclerosis, myocardial infarction, congestive heart failure)

    NEUROLOGICAL history of neurological conditions including:
    - Multiple Sclerosis
    - Parkinson’s disease
    - Alzheimer’s disease or dementia disorders

    IMMUNOSUPPRESSION history of any major immunosuppressive mechanisms including:
    - Calcineurin inhibitors
    - Exogenous glucocorticoids
    - Biological agents
    - Anti-TNF factors
    - Systemic chemotherapeutic anti-neoplastic agents
    - Transplantation (eg solid organ, bone marrow, cornea etc)

    MENTAL HEALTH AND WELL BEING history of having been diagnosed by a clinician with any of the following:
    - Depression
    - Bipolar disorder
    - Schizophrenia or delusional disorder
    - Eating disorder (eg anorexia and / or bulimia)

    INFECTIOUS DISEASES
    - Known to have HIV, HBV and/or HCV infection
    - Known to have been exposed to HIV, HBV and/or HCV in the preceding 12 months
    - Risk of Creutzfeldt-Jakob disease (CJD) or variant CJD
    - Originate from or share sexual partners or have a parent who originates from areas with high-incidence Human T-cell Lymphotropic Virus eg Caribbean, Japan, South America and Africa.
    - Positive microbiology testing for any of the pathogens described donor testing schedule

    HIGH RISK ACTIVITIES FOR BLOODBORNE INFECTIONS
    Engaged in any known high risk activities for blood-borne infections, including:
    - Sexual contact with an individual with known or suspected HIV, AIDS and/or hepatitis
    - Sexual contact with a man who has had sex with another man
    - Sex for drugs or money (both receiving and/or paying)
    - Use of illicit drugs including IV, oral or inhaled
    - Tattoo or body piercing in the preceding 6 months

    MEDICATIONS, PROBIOICS AND VACCINATIONS
    - History of proton pump inhibitor use
    - History of antibiotics within the preceding 3 months
    - History of receiving growth hormone, insulin from cows or cloting factor concentrates
    - History of receiving an experimental medicine or experimental vaccine
    - History of VSL3 probiotic food supplement or Mutaflor probiotic use
    - History of receiving a live vaccination within the preceding one month

    DIETARY, SOCIAL AND TRAVEL HISTORY
    - Participation in a strict vegan diet
    - Work or volunteering activities in which the donor comes into contact with animal or human tissues
    - Any previous tobacco use
    - Travelled outside Europe, North America or Australasia in the preceding 3 months

    FAMILY HISTORY
    - History of a first degree relative diagnosed with colon cancer under the age of 55
    - History of a first degree relative having inflammatory bowel disease

    The following are exclusion criteria which if highlighted in the donor health questionnaire must be explored in detail with the donor.
    • History of any malignancy other than gastrointestinal malignancy
    • Use of medications not listed as absolute exclusion criteria
    • Other medical conditions highlighted but not listed as an absolute exclusion criteria
    • High risk occupation e.g. microbiology technician, health care worker, sewerage worker, vet, mortuary technician etc.
    • Travel abroad in the last 3 months with associated febrile illness
    • Travel associated risk of Zika virus infection (exclude for 1 month post return from an endemic country)
    • Illness other than that involving the gastrointestinal tract in the last 2 weeks

    Patients:
    1.Partial Mayo score ≤3
    2.Partial Mayo score 9
    3.Rectal bleeding subscore of 0 on the partial Mayo
    4.Stool positive for Clostridium difficile or infection by either PCR or ELISA
    5.Positive for Hepatitis A/B/C, and/or Human Immunodeficiency Virus (HIV) infection
    6.Antibiotics within last 3 months prior to screening visit
    7.Systemic/topical steroids in the preceding 2 weeks prior to screening visit
    8.Biologics in the preceding 3 months prior to screening visit
    9.Commercial probiotics and prebiotics in the preceding 3 months prior to screening visit
    10.On oral nutritional supplements or enteral/parenteral nutrition in the preceding 4 weeks prior screening visit
    11.Pregnant or lactating. Spot urine testing will be performed at screening to rule out pregnancy in women of
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is a composite quantitative and qualitative assessment based on efficacy, acceptability and safety of FMT.
    Clinical Outcome Measures
    • Clinical response (primary measure of efficacy) defined as at least a 3 point reduction in the full Mayo score at week 8, and 30% reduction from randomisationand at least 1 point reduction of rectal bleeding subscore or an absolute rectal bleeding subscore of 0 or 1;
    • Clinical remission at week 8 (Mayo score of ≤2, with no subscore >1);
    • Participant’s weight;
    • Quality of Life (QoL) using SF36 and IBDQ in adults (16 years of age and above)
    • Quality of Life (QoL) using PedsQL in paediatrics (less than 16 years of age)
    • Paediatric Ulcerative Colitis Activity Index (PUCAI) (adults and children);
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis for the STOP-Colitis pilot study will start once the last randomised patient reaches the 12 week follow-up assessment, and data has been provided.
    E.5.2Secondary end point(s)
    Mechanistic Outcome Measures
    • Faecal calprotectin;
    • Measures of microbiome (faecal and mucosal);
    • Mucosal healing;
    • Urinary metabolome (SCFA);
    • CRP;

    Other Outcome Measures
    • Time from stool donation to treatment.
    • Association between the donor’s dietary profile and microbiome
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 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) Yes
    E.8.2.2Placebo No
    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 concerned4
    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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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: 2
    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: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state30
    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)
    The FMT is only given as part of this trial for UC and would not be available otherwise. FMT treatment duration is complete at 8 weeks, therefore if patients participate they would receive the full dose FMT as per treatment allocation.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Birmingham Clinical Trials Unit, University of Birmingham
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-22
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed Apr 24 22:06:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA