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    The EU Clinical Trials Register currently displays   42157   clinical trials with a EudraCT protocol, of which   6934   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-005165-31
    Sponsor's Protocol Code Number:LPS14914
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-05-14
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2016-005165-31
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Comparative Study to Assess the Efficacy and Safety of Spores of Enterogermina in Combination with Oral Rehydration Therapy (ORT) and Zinc Versus Placebo in Combination with ORT and Zinc Administered for 5 Days in the Treatment of Acute Diarrhea in Children
    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 Combination with ORT and Zinc for 5 Days Treatment in Children with Acute Diarrhea in India
    A.3.2Name or abbreviated title of the trial where available
    KIDDIE
    A.4.1Sponsor's protocol code numberLPS14914
    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 Aventis Groupe
    B.5.2Functional name of contact pointYasmine Oulbani
    B.5.3 Address:
    B.5.3.1Street Address54 rue de la Boétie
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75008
    B.5.3.4CountryFrance
    B.5.4Telephone number+33 1 55 71 23 94
    B.5.6E-mailYasmine.Oulbani@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-Synthelabo (India) Private Limited
    D.2.1.2Country which granted the Marketing AuthorisationIndia
    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 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 INNBacillus clausii
    D.3.9.2Current sponsor codeSSR29263
    D.3.9.3Other descriptive nameBACILLUS CLAUSII
    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 number2
    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 placeboOral 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
    Acute diarrhea
    E.1.1.1Medical condition in easily understood language
    Diarrhea
    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 PT
    E.1.2Classification code 10012735
    E.1.2Term Diarrhoea
    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 demonstrate the efficacy of B clausii probiotic strain (Enterogermina) in combination with oral rehydration therapy (ORT) and Zinc compared to placebo in combination with ORT and Zinc, for a period of 5 days in Indian children with acute diarrhea
    E.2.2Secondary objectives of the trial
    -To evaluate the safety and tolerability of Enterogermina in Indian children with acute diarrhea.
    -To evaluate efficacy of Enterogermina on frequency of stool per day.
    -To evaluate the impact of Enterogermina on dehydration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Suffering from acute diarrhea of less than 48 hours duration. Diarrhea is defined as unusual loose or watery stools at least 3 times in previous 24 hours period with no signs of dehydration or some dehydration WHO classification.
    - Whose parent/legal guardian has given a written informed consent to participate for his/her child in the study at the time of enrollment.
    E.4Principal exclusion criteria
    - Known hypersensitivity to B clausii or any of the excipients or other probiotics.
    - Children suffering from chronic gastrointestinal disease (as Crohn’s disease, hemorrhagic recto-colitis, irritable bowel syndrome, short gut syndrome and inflammatory bowel disease).
    - History of or current presence of blood (hematochezia), pus, or mucus in stools within the previous 3 months.
    - Persistent diarrhea (a diarrhea episode which lasts more than 14 days).
    - Clinically significant signs and/or symptoms of parasitic or bacterial diarrhea.
    - Severe or persistent vomiting as per Investigator’s judgment.
    - Severe dehydration (WHO classification).
    - Severe malnutrition defined as <50% weight for age (IAP classification).
    - Treatment with antibiotics or antiparasitics within a period of 2 weeks before enrollment.
    - Treatment with probiotics or prebiotics within a period of 2 weeks before enrollment: the use of probiotics and prebiotics in dairy food such as yoghurt, cheese, or milk prior to the study is permitted. Formula containing probiotics and prebiotics are forbidden during the study.
    - Treatments with anti-diarrhea within 2 weeks before enrollment including but not limited to:
    - Anti motility or antiperistaltic drugs (eg, loperamide);
    - Adsorbents (eg, diosmectite);
    - Anti secretory Drugs (eg, racecadotril);
    - Herbal remedies.
    - Laxative use within 2 weeks before enrollment.
    - Corticosteroids treatment except inhalation, intranasal, ophthalmic and topical formulations within 2 weeks before enrollment. For long term oral or intravenous steroid within 6 months before enrollment.
    - History of or current known conditions to produce immunodeficiency:acquired immune deficiency syndrome, other congenital immunodeficiency syndrome, immune-suppressors therapy such as steroids, anticancer drugs, etc.
    - Chronic diseases of endocrine, cardiovascular, renal or respiratory system or any other clinically significant condition that can jeopardize patient condition or study outcomes as judged by the Investigator.
    - Critically ill patients according to Investigator’s clinical judgment.
    - Presence of an indwelling vascular access line.
    - Patients with known history of or current pancreatitis.
    - History of abdominal surgery.
    - Bilious emesis.
    - Patient previously enrolled in this study or have participated to another investigational trial within 3 months.
    E.5 End points
    E.5.1Primary end point(s)
    Duration of acute diarrhea (expressed in hours) - Counted from the time of randomization up to recovery (the first normal stool as recorded according to Bristol score; a score <5 is described as normalization of stool).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Randomization time to Day 5
    E.5.2Secondary end point(s)
    1. Number of patients with Adverse Events (AE) including Serious adverse events (SAE), Adverse event of Special Interest (AESI) - Descriptive analysis (% of AE, SAE and AESI)

    2. Frequency of stool per day - Frequency of stool per day: 1 time, 2 times, 3 times, and more than 3 times

    3. Dehydration status evaluated - Dehydration status (no dehydration, some dehydration, severe dehydration) evaluated per WHO classification
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Randomization time to AE recovery

    2. and 3. Randomization time to Day 5
    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 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA Yes
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    India
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months15
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 462
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 150
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 312
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric population (from 6 months to 5 years)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 462
    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
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: India
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