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    The EU Clinical Trials Register currently displays   39229   clinical trials with a EudraCT protocol, of which   6426   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2019-001618-41
    Sponsor's Protocol Code Number:FERARO
    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:2020-03-02
    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 number2019-001618-41
    A.3Full title of the trial
    FERARO: A prospective, randomised placebo controlled feasibility trial of Faecal microbiota Transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can restoring the balance of healthy bowel bacteria help to fight antibiotic resistant bugs?
    A.3.2Name or abbreviated title of the trial where available
    FERARO
    A.4.1Sponsor's protocol code numberFERARO
    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 SponsorGuy's and St Thomas NHS Foundation Trust
    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 supportNIHR
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGuy's and St Thomas' NHS Foundation Trust
    B.5.2Functional name of contact pointSimon Goldenberg
    B.5.3 Address:
    B.5.3.1Street AddressDirectorate of Infection 5th Floor North Wing St Thomas’ Hospital Westminster Bridge Road London
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE1 7EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0207 188 8515
    B.5.6E-mailsimon.goldenberg@gstt.nhs.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 for Transplantation
    D.3.4Pharmaceutical form Capsule, hard
    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 INNFaecal Microbiota
    D.3.9.3Other descriptive nameFaecal Microbiota
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number240
    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
    Gastrointestinal colonisation and infection with Extended Spectrum Beta-lactamase (ESBL) producing Enetrobacteriales and Carbapenemase Producing Enetrobacteriales
    E.1.1.1Medical condition in easily understood language
    Antibiotic resistant bacteria
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10004052
    E.1.2Term Bacterial resistance
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10034133
    E.1.2Term Pathogen resistance
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 determine the feasibility of administering capsulised FMT to participants with the eventual aim of eliminating or reducing stool carriage of MDRGNO as detected by stool culture and PCR for up to 6 months after end of therapy.

    E.2.2Secondary objectives of the trial
    Feasibility
    The study will continue to measure how feasible it is to conduct a clinical trial of FMT treatment, by measuring the following:

    - no. of patients meeting the eligibility criteria for the study
    - no. of patients receiving the treatment
    - no.of patients returning for follow up appointments
    - no.of patients providing stool samples

    The ability to recruit enough healthy donors to manufacture the FMT needed for the trial will also be measured.

    Efficacy
    The presence of ARB in stool samples provided by patients after receiving FMT or placebo will be measured to see if FMT reduces the amount of bugs in the gut.

    Safety and Tolerability
    The proportion of patients experiencing side effects, and any adverse events will be measured.

    The secondary objectives will provide the evidence needed to determine how to measure if the treatment works (the primary outcome) in a larger clinical trial, and the number of people needed to take part.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participant / patient Inclusion criteria

    • Adult patients (age >18 years or older at time of randomisationconsent)
    • Current or previous patient at Guy’s and St Thomas’ NHS Foundation Trust
    • Ability to understand the purpose, potential benefits and risks of the study and capable of giving informed consent. The participant must be able to provide written informed consent.
    • Documented gastrointestinal carriage of ESBL or CPE (stool sample) in the 21 days prior to consent.
    • Symptomatic infection with the same target organism of interest in the preceding 6 months

    Donor Inclusion criteria

    • Aged between 18 and 60 years of age
    • Body mass index between 18 and 30
    E.4Principal exclusion criteria
    Participant / patient Exclusion criteria

    • Pregnancy or planned pregnancy. Urine testing will be performed at randomisation to rule out pregnancy in females.
    • Breastfeeding
    • Severe or life-threatening food allergy
    • Allergy or other contraindication to omeprazole, IMP or placebo ingredients
    • Treatment with systemic antibiotic on the day of and day prior to 1st IMP/placebo dosing to the end of the dosing period
    • Treatment with pre or probiotics in the 4 weeks prior to randomisation and for the duration of the study.*
    • Severe immunodeficiency;
    o systemic chemotherapy <30 days from baseline or planned chemotherapy within the upcoming 6 months
    o Known HIV infection with CD4 count <250 cells/uL
    o Known neutropenia with absolute neutrophils <1.0x109
    o Prolonged treatment with corticosteroids (equivalent to prednisone >60mg daily for > 30 days) within 8 weeks of randomisation
    • Life expectancy <6 months
    • Swallowing disorder, oral-motor dyscoordination or likely inability/unwillingness to ingest study medication
    • Patients who have received another investigational drug or device within 4 months prior to randomisation

    * There are no universally accepted definitions of pre and probiotics, and there are a plethora of products available. These substances are often contained in several commonly consumed foodstuffs e.g. yoghurt, cheese, beer etc. For the purposes of this study patients who consume foodstuffs containing pre and probiotics will not be excluded from the trial, other products will be reviewed on a case by case basis. A rule of thumb to aid decision making is to allow products that can be found in the food aisles of supermarkets and exclude products that can found in the pharmacy/health products or vitamins aisle.

    Donor Exclusion criteria

    • Not have received any antimicrobials within the past 3 months
    • Not have any known prior exposure to HIV and/or viral hepatitis, and known previous or latent tuberculosis
    • Not have any risk factors for blood borne viruses, including high risk sexual behaviours, use of illicit drugs, any tattoo/body piercing/needlestick injury/blood transfusion/acupuncture, all within the previous 6 months
    • Signs or symptoms consistent with Covid-19 / a nose/throat and/or stool sample with detectable SARS-CoV-2
    • Not received a live attenuated vaccine within the past 6 months
    • Not have any underlying gastrointestinal conditions/symptoms (e.g., history of IBD, irritable bowel syndrome (IBS), chronic diarrhoea, chronic constipation, coeliac disease, bowel resection or bariatric surgery),
    • Not have also any acute diarrhoea/gastrointestinal symptoms within the 2 weeks prior to donating
    • Not have any family history of any significant gastrointestinal conditions (e.g., family history of Inflammatory Bowel Disease (IBD) or colorectal cancer)
    • Not have any history of atopy (e.g., asthma, eosinophilic disorders)
    • Not have any systemic autoimmune conditions
    • Not have any metabolic conditions, including diabetes and obesity
    • Not have any neurological or psychiatric conditions, or known risk of prion disease
    • Not have any history of chronic pain syndromes, including chronic fatigue syndrome and fibromyalgia
    • No have any history of any malignancy
    • Not currently taking any regular medications
    • No history of taking the following medications within the past 3 months; proton pump inhibitors, immunosuppression, chemotherapy.
    • No history of receiving growth hormone, insulin from cows or clotting factor concentrates.
    • No history of receiving an experimental medicine or vaccine within the past 6 months
    • No history of travel to tropical countries within the past 6 months
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is the consent rate (as a proportion of participants who fulfil inclusion / exclusion criteria). This will be used to determine if a substantive trial is feasible.

    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome is a composite measure which can only be assessed once all patients have had the opportunity to participate, and thus will only be measured at the end of the trial.
    E.5.2Secondary end point(s)
    The secondary endpoints of the study are to provide preliminary evidence of efficacy for a substantive randomised controlled trial with the purpose of
    choosing the optimal primary outcome estimating the parameters for sample size calculation

    Secondary outcomes of feasibility are;
    Proportion of patients fulfilling inclusion / exclusion criteria
    Proportion of patients receiving IMP / placebo (as a % of those consenting)
    Proportion of patients returning for follow up visits (face to face visit at Day 40)
    Proportion of patients providing follow up stool samples (Days)
    Ability to recruit sufficient healthy donors to manufacture all FMT doses to meet demands of this and a future substantive RCT. Assessed by delay in dosing patients (measured in days)

    Additional feasibility assessments will include:

    Collection of data that may be used in estimating of costs/resources needed to provide FMT in the NHS.
    An embedded qualitative study to explore views and experiences of research participants.


    Secondary outcomes of efficacy are;
    Gastrointestinal carriage of CRE / ESBL (detected / not detected) by stool culture over time (days 10, 40, 100 and 190)
    Gastrointestinal carriage of CRE / ESBL (detected / not detected) by multiplex PCR over time (days 10, 40, 100 and 190)

    Secondary outcomes of safety and tolerability are;
    proportion of patients experiencing reflux following administration of FMT
    Proportion of patients suffering intolerable (resulting in withdrawal from the study) gastrointestinal side effects (including diarrhoea, constipation, abdominal pain, flatulence and bloating). This will be assessed by direct questioning and completion of a short patient questionnaire.
    identification of unanticipated harms involved with administration of FMT.
    occurrence of any adverse event / serious adverse event
    E.5.2.1Timepoint(s) of evaluation of this end point
    Feasibility assessments will be evaluated at end of trial (additional assessments at month 6 and 12) with the exception of the qualitative study which will be performed during months 6 to 12 of the study.

    Safety and tolerability assessments will be assessed for each patient following each dosing day (days 1, 2 and 3) and all follow up timepoints (days 10, 40, 100 and 190) as well as any unscheduled participant visits.
    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 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 Yes
    E.8.1.4Double blind No
    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 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
    The end of the trial will be defined as database lock.
    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 months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 Yes
    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 state80
    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)
    There are no plans for continued provision of FMT capsules to participants. As this is a feasibility trial, it is not designed or powered to show efficacy of the treatment, therefore this would first need to be confirmed in a substantive trial.
    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 Decision2020-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-20
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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