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    Summary
    EudraCT Number:2019-003433-41
    Sponsor's Protocol Code Number:APHP180583
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-31
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-003433-41
    A.3Full title of the trial
    A prospective, multi-center, double blind randomized trial of fecal microbiota transplantation (FMT) delivered by capsule versus placebo in severe irritable bowel syndrome (IBS) - ICEBOAT (Ibs CapsulE microBiOtA Transplantation)
    Essai randomisé prospectif multicentrique en double aveugle de transplantation de microbiote fécal (TMF) administrée par gélules versus placebo dans le syndrome de l’intestin irritable sévère (SII)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A prospective, multi-center, double blind randomized trial of fecal microbiota transplantation (FMT) delivered by capsule versus placebo in severe irritable bowel syndrome (IBS) - ICEBOAT (Ibs CapsulE microBiOtA Transplantation)
    Essai randomisé prospectif multicentrique en double aveugle de transplantation de microbiote fécal (TMF) administrée par gélules versus placebo dans le syndrome de l’intestin irritable sévère (SII)
    A.3.2Name or abbreviated title of the trial where available
    ICEBOAT
    ICEBOAT
    A.4.1Sponsor's protocol code numberAPHP180583
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI - Hôpital Saint-Louis
    B.5.3 Address:
    B.5.3.1Street Address1 Avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33144841726
    B.5.5Fax number33144841701
    B.5.6E-mailsabrina.williams@aphp.fr
    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 nameFecal Microbiota
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    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
    Adult patients with severe Irritable Bowel Syndrome (IBS) diagnosed
    Patients adultes atteints d’une forme sévère de Syndrome de l’Intestin Irritable (SII) diagnostiquée
    E.1.1.1Medical condition in easily understood language
    Adult patients with severe Irritable Bowel Syndrome (IBS) diagnosed
    Patients adultes atteints d’une forme sévère de Syndrome de l’Intestin Irritable (SII) diagnostiquée
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10023003
    E.1.2Term Irritable bowel syndrome
    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
    To evaluate the efficacy of oral capsules containing frozen fecal microbiota (FMT) vs sham FMT on IBS severity score at 12 weeks in patients with irritable bowel syndrome with severe disease refractory to conventional treatments
    Évaluer l'efficacité de la TMF réalisée au moyen de gélules contenant des selles congelées par rapport à un à un placebo sur le score de sévérité du SII à 12 semaines chez des patients présentant une forme sévère du syndrome de l'intestin irritable (IBS-SSS> 300) réfractaire aux traitements conventionnels
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of oral capsules containing frozen fecal microbiota (FMT) vs sham FMT on IBS severity score at 12 weeks i
    2. FMT success: patient’s microbiota 12 weeks after FMT closer to that of the donor than the patient’s microbiota before FMT.
    3. Intestinal microbiota composition at week 12 and 24
    4. Efficacy (decrease in IBS severity >75 points) according to FMT success.
    5. Efficacy according to FDA on composite criteria at 12 or 24 weeks
    6. IBS severity at 12 weeks by donors (one donor giving FMT to several patients)
    7. IBS severity at 12 weeks and at 24 weeks by IBS subtypes according to transit pattern IBS severity
    8. IBS Quality of life at 12 weeks and 24 weeks
    9. Patient’s perception of FMT
    10. Secondary effects of FMT.
    1. Évaluer l'efficacité de capsules orales contenant du microbiote fécal congelé (FMT) par rapport à une FMT fictive sur le score de sévérité du SII à 12 semaines
    2. Succès de la TMF : le microbiote du patient 12 semaines après la TMF est-il plus proche de celui du donneur que le microbiote du patient avant la TMF?
    3. Composition du microbiote intestinal aux semaines 12 et 24.
    4. Efficacité (diminution de la sévérité du SII >75 points) en fonction du succès du TMF.
    5. Efficacité selon le critère de la FDA sur des critères composites à 12 ou 24 semaines.
    6. Sévérité du SII à 12 semaines selon les donneurs
    7. Sévérité du SII à 12 semaines et à 24 semaines par sous-types de SII selon le schéma de transit.sévérité du SII
    8. Qualité de vie du SII à 12 semaines et à 24 semaines.
    9. Perception de la FMT par le patient (questionnaire pour une évaluation correcte de la FMT ou du placebo et de l'acceptabilité de la FMT) (Annexe D), effets secondaires de la FMT.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years and < 75 years
    - IBS defined according to Rome IV definition (IBS-C, IBS-D or IBS-M)
    - Severe disease (IBS-SSS >300) and refractory to at least two previous treatment strategies.
    - Patient with health insurance (AME excepted)
    - Informed Written consent
    - For women with childbearing potential, efficient contraception for the duration of the participation to the study
    Patients avec SII
    - Âge≥18ans et<75 ans
    - SII défini selon les critères de Rome IV (SII-C, SII-D ou SII-M),
    - Forme sévère de SII (IBS-SSS> 300), réfractaire à au moins deux stratégies de traitement antérieures.
    - Patient avec assurance maladie
    - Consentement écrit éclairé
    - Pour les femmes en âge de procréer, contraception efficace pendant toute la durée de la participation à l'étude
    E.4Principal exclusion criteria
    - Other chronic gastrointestinal disease (celiac disease, inflammatory bowel disease)
    - participants if there is a reason to suspect an alternative diagnosis to the IBS complaints
    - Surgical intervention in the gastrointestinal region except for appendectomy, hernia repair, cholecystectomy and hemorroidectomy
    - Treatment preceding FMT with: antibiotics, antifungic or probiotics treatment < 4 weeks, or factors that may affect the composition of intestinal microbiota
    - Abuse of alcohol or drugs
    - Pregnancy or breastfeeding
    - Participation in any other interventional study
    - Patients under legal protection.
    - Acute COVID-19 infection
    - Contraindication to fecal transplantation
    - Autre maladie gastro-intestinale chronique (maladie coeliaque, maladie inflammatoire de l'intestin)
    - Les patients chez qui il y a une raison de suspecter un diagnostic ne correspondant pas au SII,
    - Intervention chirurgicale gastro-intestinale à l'exception de l'appendicectomie, réparation des hernies, cholécystectomie et de l'hémorroïdectomie
    - Traitement précédant la FMT avec : traitement antibiotique, antifongique ou probiotique < 4 semaines, ou facteurs pouvant affecter la composition du microbiote intestinal
    - Abus d'alcool ou de drogues
    - Grossesse ou allaitement
    - Participation à toute autre étude interventionnelle
    - Infection aiguë au COVID-19
    - Contre-indication à la transplantation fécale
    - Patient sous protection légale.
    E.5 End points
    E.5.1Primary end point(s)
    Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 75 points decrease in IBS-SSS.
    Diminution de la sévérité du SII à 12 semaines étant définie par le pourcentage de patients présentant une diminution d'au moins 75 points de l’IBS-SSS (score de sévérité de la maladie, score allant de 0 à 500)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 semaines après FMT
    12 semaines après la transplantation fécale
    E.5.2Secondary end point(s)
    1. Decrease in IBS severity at 12 weeks defined by the percentage of patients having at least a 50 points decrease in IBS-SSS.
    2. FMT success : patient’s microbiota 12 weeks after FMT closer to that of the donor than the patient’s microbiota before FMT. The composition of the patient’s fecal microbiota 12 weeks after FMT will be compared to the patient’s microbiota before transplantation and to the donor using the Sorensen similarity index. The FMT will be considered as a success if the Sorensen index [patient after FMT vs donor] > Sorensen index [patient after FMT vs patient before FMT] and if the Sorensen index [patient after FMT vs donor] ≥ 0,6. The composition of fecal microbiota will be measured by pyrosequencing (16S RNA).
    3. Intestinal microbiota composition and diversity at week 12 and 24 assessed by 16s sequencing. Microbiota composition and diversity assessed by 16s sequencing at week 12 and 24, compared to baseline and to healthy volunteers donor’s microbiota. Microbiota composition will be assessed using Qiime pipeline and analyzed at all phylogenetic levels. Diversity will be evaluated using Shannon index, Simpson index, Chao1 index and number of observed species.
    4. Efficacy (decrease in IBS severity >75 points) at week 24 according to FMT success.
    5. EMA Endpoint at week 12 and 24 defined as a patient who fulfils the response criteria (simultaneous improvement of transit and abdominal pain) displayed in the following for at least 50% of the observation time.
    6. Percentage of responders in the different subgroups IBS-D, IBS-C and IBS-M using the primary endpoint at week 12 and 24.
    7. Mean IBS-SSS (IBS severity), comparison between FMT and placebo at 12 and 24 weeks)
    8. Mean IBS-QoL score (IBS Quality of life) comparison between FMT and placebo at 12 and 24 weeks (Drossman et al. 2000)
    9. Patient’s perception of FMT : Questionnaire for correct assessment of FMT or placebo and FMT acceptability) at V2 (FMT administration)
    10. Questionnaire for assessment of FMT secondary effects à V3.
    1. Diminution de la sévérité du SII à 12 semaines, définie par le pourcentage de patients ayant une diminution d'au moins 50 points du SII-SSS.
    2. Succès de la TMF : microbiote du patient 12 semaines après la TMF plus proche de celui du donneur que du microbiote du patient avant la TMF. La composition du microbiote fécal du patient 12 semaines après la FMT sera comparée au microbiote du patient avant la transplantation et à celui du donneur à l'aide de l'indice de similarité de Sorensen. La TMF sera considérée comme un succès si l'indice de Sorensen [patient après TMF vs donneur] > indice de Sorensen [patient après TMF vs patient avant TMF] et si l'indice de Sorensen [patient après TMF vs donneur] ≥ 0,6. La composition du microbiote fécal sera mesurée par pyroséquençage (ARN 16S).
    3. Composition et diversité du microbiote intestinal aux semaines 12 et 24 évaluées par séquençage 16s. Composition et diversité du microbiote évaluées par séquençage 16s aux semaines 12 et 24, comparées à la ligne de base et au microbiote de volontaires sains donneurs. La composition du microbiote sera évaluée à l'aide du pipeline Qiime et analysée à tous les niveaux phylogénétiques. La diversité sera évaluée en utilisant l'indice de Shannon, l'indice de Simpson, l'indice de Chao1 et le nombre d'espèces observées.
    4. Efficacité (diminution de la sévérité du SII >75 points) à la semaine 24 selon le succès du TMF.
    5. Point final de l'EMA aux semaines 12 et 24 défini comme un patient qui remplit les critères de réponse (amélioration simultanée du transit et de la douleur abdominale) affichés dans ce qui suit pendant au moins 50% du temps d'observation.
    6. Pourcentage de répondeurs dans les différents sous-groupes IBS-D, IBS-C et IBS-M en utilisant le critère primaire aux semaines 12 et 24.
    7. Moyenne de l'IBS-SSS (sévérité du SII), comparaison entre FMT et placebo à 12 et 24 semaines).
    8. Score moyen de l'IBS-QoL (qualité de vie du SII), comparaison entre le FMT et le placebo à 12 et 24 semaines (Drossman et al. 2000).
    9. Perception de la FMT par le patient : Questionnaire d'évaluation correcte de la FMT ou du placebo et de l'acceptabilité de la FMT à V2 (administration de la FMT)
    10. Questionnaire pour l'évaluation des effets secondaires du FMT à V3.
    E.5.2.1Timepoint(s) of evaluation of this end point
    W12 and W24
    W0 and W4
    W12 et W24
    W0 et W4
    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) 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 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 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 concerned8
    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 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
    Dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state150
    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
    Aucun
    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 Decision2023-03-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-08-30
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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