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    Summary
    EudraCT Number:2019-002116-10
    Sponsor's Protocol Code Number:i3.1_IBS+SIBO
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-002116-10
    A.3Full title of the trial
    Interventional post-marketing study to evaluate i3.1 efficacy on SIBO (Small Intestinal Bacterial Overgrowth)reduction in IBS (Irritable bowel syndrom) patients
    Estudio intervencional aleatorizado post-autorización para evaluar la capacidad del probiótico i3.1 de reducir el sobrecrecimiento bacteriano del intestino delgado (SIBO) en pacientes con síndrome de intestino irritable (SII)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Post-autorization study to compare the eficacy of the food supplement i3.1 and the antibiotic Rifaximin on SIBO (Small Intestinal Bacterial Overgrowth) reduction in patients suffering IBS (Irritable bowel syndrom).
    Estudio post-autorización para comparar la eficacia del complemento alimenticio i3.1 y el antibiótico Rifaximina en la reducción de SIBO (Sobrecrecimiento bacteriano en intestino delgado) en pacientes que padecen IBS (Síndrome intestino irritable).
    A.3.2Name or abbreviated title of the trial where available
    i3.1_IBS + SIBO
    i3.1_IBS + SIBO
    A.4.1Sponsor's protocol code numberi3.1_IBS+SIBO
    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 SponsorAB-Biotics S.A.
    B.1.3.4CountrySpain
    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 supportAB-Biotics S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB-Biotics S.A.
    B.5.2Functional name of contact pointAB-Biotics
    B.5.3 Address:
    B.5.3.1Street AddressEsade Creapolis Av. De la Torre Blanca, 57 3B11
    B.5.3.2Town/ citySant Cugat del Vallès
    B.5.3.3Post code08172
    B.5.3.4CountrySpain
    B.5.4Telephone number003493592 97 97
    B.5.6E-mailaguilo@ab-biotics.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name SPIRAXIN
    D.2.1.1.2Name of the Marketing Authorisation holderALFASIGMA ESPAÑA, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameSPIRAXIN
    D.3.2Product code 62.250
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastric use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIFAXIMIN
    D.3.9.1CAS number 80621-81-4
    D.3.9.2Current sponsor code656645.9
    D.3.9.3Other descriptive nameDermodis
    D.3.9.4EV Substance CodeSUB10312MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    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) + Small Intestinal Bacterial Overgrowth (SIBO)
    Síndrome Intestino Irritable (SII) + Sobrecrecimiento bacteriano intestinal (SIBO)
    E.1.1.1Medical condition in easily understood language
    Irritable Bowel Syndrome (IBS) + Small Intestinal Bacterial Overgrowth (SIBO)
    Síndrome Intestino Irritable (SII) + Sobrecrecimiento bacteriano intestinal (SIBO)
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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 main objective is to verify the ability of the probiotic i3.1 to reduce SIBO (determined through exhaled gas) in IBS patients and how the effect correlates with the symptomatic amelioration.
    El objetivo principal es verificar la capacidad del probiótico i3.1 para reducir el SIBO (determinado a partir de los niveles de gases exhalados de origen bacteriano) en pacientes con SII, y la correlación de dicho efecto con la mejoría sintomática del SII.
    E.2.2Secondary objectives of the trial
    Study the effect of the probiotic in the intestinal microbiota at compositional taxonomical level and in specific intestinal anxiety. Besides, the efficacy of both treatments will be compared.
    Como objetivos secundarios se estudiará el efecto del probiótico en la microbiota intestinal a nivel composicional taxonómico y en la ansiedad específica gastrointestinal. Además, se comparará la eficacia del tratamiento entre los dos grupos de estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    18-65 years patients, diagnosed with IBS according to Roma IV (independently of the subtype) following the criteria:

    • Positive for SIBO, (H2 and/or CH4), according to the Northamerican consensus.
    • Start i3.1 intake.
    • Signed informed consent.
    • Able to understand and follow the indications and procedures of the protocol.
    Patients taking a regular dosis of PIP or anstispasmodics are allowed to participate. Any regime alteration must be documented.
    Pacientes de 18 a 65 años, con diagnóstico de SII según criterios de Roma-IV , independientemente del subtipo, que cumplan los siguientes criterios:

    • Sean positivos para SIBO, sea por H2 y/o CH4, según los criterios del Consenso Norteamericano.
    • Comiencen a tomar el probiótico i.3.1 (1 capsula al día).
    • Firmen el Consentimiento Informado.
    • Capacidad de comprender las indicaciones del presente protocolo.
    Se permite la inclusión de pacientes que tomen dosis estables de inhibidores de bomba de protones (IBPs) o antiespasmódicos. Se deberá notificar cualquier alteración de la pauta durante el estudio.
    E.4Principal exclusion criteria
    • Use of antibiotics 4 weeks prior to study inclusion.
    • Use of probiotics 2 weeks prior to study start.
    • Use of loperamide or other prokinetics 1 week prior to study start.
    • Use of Plantago ovata, lactulose or other laxatives 1 week prior to study start.
    • Use of antidepressives.
    • Suspect or diagnose of celiac disease, Sospecha o diagnostico confirmado de enfermedad celíaca, inflammatory bowel disease, diverticulitis or endomitriosis.
    • Intestinal surgery (excluded appendectomy and herniorrhaphy).
    • short bowel syndrome or pancreatitis.
    • Treated with immunosupressors, cancer, severe cardiovascular disease, HIV, HBV or HCV-positives.
    • Other diseases which may interfere with the effect of the i.3.1.
    • Pregnant or breastfeeding.

    Use of other antibiotics must be notified during study.
    • Uso de antibióticos en las 4 semanas anteriores al inicio.
    • Uso de otros probióticos en las 2 semanas anteriores al inicio.
    • Uso de loperamida u otros prokinéticos en la semana anterior al inicio (según Consenso (13)).
    • Uso de Plantago ovata, lactulosa u otros laxantes en la semana anterior al inicio (según Consenso (13)).
    • Uso de antidepresivos.
    • Sospecha o diagnostico confirmado de enfermedad celíaca, enfermedad inflamatoria intestinal (EII), diverticulosis sintomática/diverticulitis o endometriosis.
    • Cirugía intestinal previa, excluyendo apendectomía y herniorrafía.
    • Síndrome de intestino corto o pancreatitis.
    • Tratamiento concomitante con inmunosupresivos, enfermedad oncológica, enfermedad cardiovascular grave, HIV-positivos, HBV o HCV-positivos.
    • Otras enfermedades que, a criterio del investigador, puedan interferir con el efecto del probiótico i.3.1.
    • Mujeres embarazadas, en periodo de lactancia o que deseen quedarse embarazadas durante el periodo de estudio.

    Se deberá notificar si se produce uso de antibióticos durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Change in exhaled gas from bacterial origin (CH4 y H2) measured as ppm (parts per million) by the analyzer GastroCHEKC® (Covita), after the intake of 25 gr of lactulose following the recommendations of the northamerican consensus.
    La variación de los niveles de los gases de origen bacteriano CH4 y H2 exhalados en la respiración, medidos como ppms (partes por millón), mediante el analizador GastroCHEKC® (Covita), tras la ingestión de 25 gr de lactulosa siguiendo las recomendaciones del Consenso Norteamericano .
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline, 4w, 8w
    basal, 4 semanas, 8 semanas
    E.5.2Secondary end point(s)
    • Change in the proportion of patients with an increase of ≥20 ppm of H2 after 90 min.
    • Change in the proportion of patients with an increase of ≥10 ppm of CH4 after 90 min.
    • Change in global symptoms of IBS, according to the IBS-SSS scale score.
    • Change in the score of each of the 5 sub-scales in the IBS-SSS scale.
    • Change in the score of each of gastrointestinal specific anxiety according to VSI scale.
    • El cambio de la proporción de pacientes con un aumento de ≥20 ppm de H2 a los 90 minutos (13).
    • El cambio de la proporción de pacientes con un aumento de ≥10 ppm de CH4 a los 90 minutos (13).
    • El cambio de la severidad sintomática global del SII, determinada según el puntaje en la versión española de la escala IBS-SSS .
    • El cambio del puntaje en cada una de las 5 sub-escalas en la escala IBS-SSS: i) intensidad del dolor abdominal; ii) frecuencia del dolor abdominal; iii) intensidad de distensión abdominal; iv) satisfacción con hábito deposicional; v) interferencia con las actividades diarias.
    • El cambio del puntaje de ansiedad especifica gastrointestinal*, según la escala VSI (32).
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline, 4w, 8w
    basal, 4 semanas, 8 semanas
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) 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 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
    LVLS
    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
    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: 46
    F.1.3Elderly (>=65 years) No
    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 state46
    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
    Ninguno
    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 Decision2019-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-19
    P. End of Trial
    P.End of Trial StatusOngoing
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