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    Summary
    EudraCT Number:2022-001368-86
    Sponsor's Protocol Code Number:SIBO_SUBSTRAT
    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:2022-12-14
    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 number2022-001368-86
    A.3Full title of the trial
    RANDOMIZED, MULTICENTRIC CLINICAL TRIAL, COMPARISON BETWEEN LACTITOL AND LACTULOSE AS SUBSTRATES BREATH TEST FOR THE DIAGNOSIS OF BACTERIAL OVERGROWTH
    ENSAYO CLÍNICO ALEATORIZADO, MULTICÉNTRICO, COMPARATIVO ENTRE EL LACTITOL Y LACTULOSA COMO SUSTRATOS EN EL TEST DE AIRE ESPIRADO PARA EL DIAGNÓSTICO DE SOBRECRECIMIENTO BACTERIANO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    COMPARATIVE STUDY BETWEEN TWO SUBSTRATES FOR THE BACTERIAL OVERGROWTH BREATH TEST
    ESTUDIO COMPARATIVO ENTRE DOS SUSTRATOS PARA LA PRUEBA DE ALIENTO DE SOBRECRECIMIENTO BACTERIANO
    A.4.1Sponsor's protocol code numberSIBO_SUBSTRAT
    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 SponsorHospital Universitario de La Princesa
    B.1.3.4CountrySpain
    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 supportHospital Universitario de La Princesa
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario de La Princesa
    B.5.2Functional name of contact pointVeronica Martin Dominguez
    B.5.3 Address:
    B.5.3.1Street AddressCalle Diego de León 62. 3º planta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number0034915202254
    B.5.6E-mailveronicamartin29@yahoo.es
    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 Yes
    D.2.1.1.1Trade name LACTULOSA
    D.2.1.1.2Name of the Marketing Authorisation holderLAINCO, S.A.
    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.3.4Pharmaceutical form Oral solution
    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 INNLACTULOSE
    D.3.9.1CAS number 4618-18-2
    D.3.9.4EV Substance CodeSUB08386MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 LACTITOL
    D.2.1.1.2Name of the Marketing Authorisation holderANGELINI PHARMA 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 nameLactitol
    D.3.4Pharmaceutical form Powder for oral solution
    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 INNLACTITOL
    D.3.9.1CAS number 585-86-4
    D.3.9.4EV Substance CodeSUB08385MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Intestinal bacterial overgrowth
    Sobrecrecimeinto bacteriano intestinal
    E.1.1.1Medical condition in easily understood language
    Intestinal bacterial overgrowth
    Sobrecrecimeinto bacteriano intestinal
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071061
    E.1.2Term Small intestinal bacterial overgrowth
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10065439
    E.1.2Term Hydrogen breath test
    E.1.2System Organ Class 10022891 - Investigations
    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 concordance between lactulose and lactitol as substrates in the performance of the breath test in the diagnosis of bacterial overgrowth
    Evaluar la concordancia entre lactulosa y lactitol como sustratos en la realización del test de aliento en el diagnóstico de sobrecrecimiento bacteriano
    E.2.2Secondary objectives of the trial
    • Evaluate the symptoms produced after the administration of each substrate during the breath test for the diagnosis of bacterial overgrowth.
    • Evaluate the late symptoms produced after the administration of each substrate during the 24 hours after performing the breath test.
    • Assess the acceptability of the breath test with each substrate by the patient.nto for the diagnosis of bacterial overgrowth.
    • Evaluar los síntomas producidos tras la administración de cada sustrato durante la realización del test de aliento para el diagnóstico de sobrecrecimiento bacteriano
    • Evaluar los síntomas tardíos producidos tras la administración de cada sustrato durante las 24 horas posteriores a la realización del test de aliento
    • Valorar la aceptabilidad del test de aliento con cada sustrato por parte del paciente.nto para el diagnóstico de sobrecrecimiento bacteriano
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients between 18 and 80 years old
    - Symptoms suggestive of intestinal bacterial overgrowth that require a diagnostic test for confirmation.
    - Signature of the informed consent for inclusion in this study by the patient.
    - Pacientes entre 18 y 80 años
    - Síntomas sugestivos de sobrecrecimiento bacteriano intestinal que precisen una prueba diagnóstica para su confirmación.
    - Firma del consentimiento informado para su inclusión en este estudio por parte del paciente.
    E.4Principal exclusion criteria
    - Patients with psychiatric or neurological disorders who are not able to comply with the recommendations prior to the tests and who cannot adequately follow the instructions during the collection of the samples.
    - History of total or partial gastrectomy, vagotomy or any type of intestinal resection (including bariatric endoscopy).
    - Pacientes con trastornos psiquiátricos o neurológicos que no sean capaces de hacer un buen cumplimiento de las recomendaciones previas a los test y que no puedan seguir adecuadamente las instrucciones durante la recogida de las muestras.
    - Antecedente de gastrectomía total o parcial, vagotomía o cualquier tipo de resección intestinal (incluida endoscopia bariátrica).
    E.5 End points
    E.5.1Primary end point(s)
    Sintoms during each test wich difeferent substract
    Concordance between SIBO trials with each substrate
    Síntomas presentes durante la prueba con cada sustrato.
    Concordancia entre las pruebas de SIBO con cada sustrato
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 month
    12 meses
    E.5.2Secondary end point(s)
    Patient preference.
    Assess the gas lifting time with each substrate
    Preferencia de los pacientes.
    Valorar el tiempo de elevacion de gases con cada sustrato
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 m
    12 m
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    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) 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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 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
    última visita del paciente
    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 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2022-12-14. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 state200
    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 treatment will be assigned by clinical practice and under the criteria of the researcher of each of the centers. Therefore, before starting the trial, as once it is over, it will be the responsible physician who decides in his clinical judgment which is the most appropriate therapeutic option
    El tratamiento se pautará por práctica clínica habitual, bajo el criterio del investigador de cada uno de los centros, según el resultado de las pruebas de aliento. Una vez finalizado el ensayo, será el médico responsable el que bajo su juicio clínico decida la opción terapéutica más adecuada.
    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 Decision2023-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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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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