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   43861   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:2018-001355-12
    Sponsor's Protocol Code Number:LPS15198
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-10-16
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001355-12
    A.3Full title of the trial
    Phase IV, randomized, double-blind, multicenter, placebo-controlled clinical trial to evaluate the efficacy and the safety of enterogermina (Bacillus clausii) in treating patients with small intestinal bacterial overgrowth
    Studio clinico di Fase IV, randomizzato, in doppio cieco, multicentrico, controllato verso placebo per valutare l’efficacia e la sicurezza di enterogermina (Bacillus clausii) nel trattamento di pazienti con aumentata crescita batterica a livello dell’intestino tenue
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy And Safety Of Enterogermina Vs Placebo In Adults With Small Intestinal Bacterial Overgrowth (SIBO)
    Efficacia e Sicurezza di Enterogermina verso placebo in adulti con aumentata crescita batterica a livello dell’intestino tenue (SIBO)
    A.3.2Name or abbreviated title of the trial where available
    BASTA
    BASTA
    A.4.1Sponsor's protocol code numberLPS15198
    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 SponsorSANOFI-AVENTIS GROUPE
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Groupe
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.p.A.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressVIALE BODIO, 37/B
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number800226343
    B.5.5Fax number0239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.com
    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 Enterogermina®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Groupe
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameENTEROGERMINA
    D.3.2Product code [SSR29263]
    D.3.4Pharmaceutical form Powder for oral suspension
    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 INNSPORE DI BACILLUS CLAUSII POLIANTIBIOTICO RESISTENTE
    D.3.9.2Current sponsor codeSSR29263
    D.3.9.4EV Substance CodeSUB88746
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms billion organisms
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typemicroorganismi antidiarroici
    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 placeboPowder for oral suspension
    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
    Small intestinal bacterial overgrowth (SIBO)
    Aumentata crescita batterica a livello dell’intestino tenue (SIBO)
    E.1.1.1Medical condition in easily understood language
    Small intestinal bacterial overgrowth (SIBO)
    Aumentata crescita batterica a livello dell’intestino tenue (SIBO)
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10071061
    E.1.2Term Small intestinal bacterial overgrowth
    E.1.2System Organ Class 100000004862
    E.1.3Condition 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 Enterogermina (Bacillus clausii [B clausii] probiotic strain) versus placebo for small intestinal bacterial overgrowth (SIBO) eradication.
    Valutare l’efficacia di Enterogermina (ceppo probiotico di Bacillus clausii [B clausii]) rispetto a placebo nelll’eradicazione dell’aumentata crescita batterica a livello dell’intestino tenue (small intestinal bacterial overgrowth, SIBO)
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of Enterogermina (B clausii) versus placebo in treating patients with SIBO.
    Valutare la sicurezza e la tollerabilità di Enterogermina (B clausii) rispetto a placebo nel trattamento di pazienti con SIBO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female patients aged >/=18 years.
    - Small intestinal bacterial overgrowth diagnosed based on positive hydrogen breath test (GBT or LBT) as described in The North American Consensus within 2 weeks prior to study entry.
    - Patients reporting recurrent bloating or feeling of abdominal distension, defined as recurrent feeling of bloating or visible distension at least 3 days/month in the last month.
    - Patients presenting abnormal stool frequency (abnormal is defined as >3 bowel movements/day and <3 bowel movements/week) and/or abnormal stool form (lumpy/hard or loose/watery stool) as per the Bristol-Stool scale.
    - Pazienti maschi e femmine di età >/=18 anni
    - Diagnosi di aumentata crescita batterica a livello dell’intestino tenue formulata in base alla positività del test del respiro (test del respiro all’idrogeno dopo assunzione di glucosio [glucose hydrogen breath test, GBT] o test del respiro all’idrogeno dopo assunzione di lattulosio [lactulose hydrogen breath test, LBT]) come descritto nel Documento di consenso nordamericano entro 2 settimane prima dell’ingresso nello studio.
    - Pazienti che segnalano gonfiore ricorrente o sensazione di distensione addominale, definiti come sensazione ricorrente di gonfiore o distensione visibile almeno 3 giorni/mese nel corso dell’ultimo mese.
    - Pazienti che presentano anomalie nella frequenza di evacuazione (per frequenza anomala si intendono >3 evacuazioni/giorno o <3 evacuazioni/settimana) e/o nella tipologia delle feci (feci irregolari/dure o molli/acquose) secondo la Scala delle feci di Bristol.
    E.4Principal exclusion criteria
    - History of intestinal surgery (except cholecystectomy and appendectomy).
    - Use of antibiotic or probiotics (medications or dietetic supplements) in the last month prior to study entry.
    - Standard medication consisting of laxative or antidiarrheal.
    - Eating disorders such as anorexia or bulimia, and/or psychosis, schizophrenia, mania, or major psychiatric illnesses needing pharmacological treatment. Well-compensated depression does not exclude a potential patient.
    - Patients not able to maintain their usual diet and lifestyle during the course of the study.
    Anamnesi di chirurgia intestinale (eccetto colecistectomia e appendicectomia).
    Uso di antibiotici o probiotici (farmaci o integratori dietetici) nell’ultimo mese prima dell’ingresso nello studio
    Trattamento standard con farmaci lassativi o antidiarroici.
    Disturbi alimentari quali anoressia o bulimia e/o psicosi, schizofrenia, mania o patologie psichiatriche maggiori con necessità di trattamento farmacologico. La depressione in buon compenso non costituisce un criterio di esclusione per un potenziale paziente.
    Pazienti non in grado di mantenere la dieta e lo stile di vita abituali nel corso dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    SIBO eradication: percentage of patients with small intestinal bacterial overgrowth (SIBO) eradication, wherein patients present a negative glucose hydrogen breath test (GBT) after 30 days of treatment.
    eradicazione della SIBO: Percentuale di pazienti con eradicazione dell' aumentata crescita batterica a livello dell’intestino tenue ( SIBO), ovvero pazienti che presentano negativizzazione del test del respiro all’idrogeno dopo assunzione di glucosio GBT dopo 30 giorni di trattamento dello studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to Day 30
    fino al giorno 30
    E.5.2Secondary end point(s)
    1. SIBO-associated symptoms (patient assessment): relief of SIBO associated symptoms such as abdominal discomfort, bloating, abdominal cramps, and stool frequency impairment.
    2. Relief of overall gastrointestinal symptoms: patient satisfaction rating of symptom improvement (satisfactory relief of overall gastrointestinal symptoms).
    3. Quality of Life (QoL)questionnaire: QoL assessed by 12-Item Short Form Survey (SF-12) questionnaire.
    4. Adverse Events: number of patients with adverse events.
    1. Sintomi associati alla SIBO (valutazione del paziente): Sollievo dai sintomi associati alla SIBO, quali disagio addominale, gonfiore, crampi addominali e alterazione della frequenza di evacuazione.
    2. Sollievo dei sintomi gastrointestinali generali: valutazione del grado di soddisfazione del paziente (miglioramento soddisfacente dei sintomi gastrointestinali generali).
    3. Questionari di Qualità della vita (quality of life, QoL): QoL valutata mediante il questionario Modulo breve a 12 voci (12-Item Short Form Survey, SF-12).
    4. Eventi avversi: Numero di pazienti con eventi avversi
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to Day 30
    2. On Day 30
    3. Up to Day 30
    4. Up to Day 30
    1. fino al giorno 30
    2. al giorno 30
    3. fino al giorno 30
    4. fino al giorno 30
    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 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 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 concerned18
    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 Information not present in EudraCT
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial 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: 214
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state214
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 214
    F.4.2.2In the whole clinical trial 214
    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
    Nessuno
    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 Decision2019-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    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-Fri Apr 26 09:02:39 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA