Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Spores

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   44335   clinical trials with a EudraCT protocol, of which   7366   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
     
    9 result(s) found for: Spores. Displaying page 1 of 1.
    EudraCT Number: 2014-004636-19 Sponsor Protocol Number: ENTER_L_01486 Start Date*: 2015-04-10
    Sponsor Name:Sanofi Aventis
    Full Title: Phase III Comparative Study to Assess the Efficacy and Safety of Oral Rehydration Therapy (ORT) in Combination With Spores of Bacillus Clausii (Enterogermina)Versus ORT Alone, Administered for 5 Da...
    Medical condition: Acute diarrhea
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10000706 Acute diarrhea LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-005165-31 Sponsor Protocol Number: LPS14914 Start Date*: 2020-05-14
    Sponsor Name:Sanofi Aventis Groupe
    Full Title: 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 Ther...
    Medical condition: Acute diarrhea
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10012735 Diarrhoea PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003444-37 Sponsor Protocol Number: ENTERR06929 Start Date*: 2016-08-26
    Sponsor Name:Sanofi
    Full Title: Bacillus clausii in the treatment of acute community–acquired diarrhea among Latin American children (cadiLAc)
    Medical condition: Diarrhea
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004856 10000706 Acute diarrhea LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004629-42 Sponsor Protocol Number: ENTER_L_01125 Start Date*: 2015-04-03
    Sponsor Name:Sanofi
    Full Title: Bacillus Clausii in Preventing Antibiotic-Associated Diarrhea Among Filipino Infant and Children: A Multi-Center, Randomized, Open-Label Controlled (Treatment vs No Treatment) Clinical Trial of Eff...
    Medical condition: Diarrhea associated to antibiotics
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004856 10000706 Acute diarrhea LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-003205-10 Sponsor Protocol Number: 12072 Start Date*: 2012-09-17
    Sponsor Name:University of Nottingham
    Full Title: A randomised placebo controlled trial of follow on Rifaximin for the prevention of relapse of Clostridium difficile associated diarrhoea.
    Medical condition: C.Difficile antibiotic-associated diarrhoeal infection
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-004934-42 Sponsor Protocol Number: PM L 0161 Start Date*: 2006-04-13
    Sponsor Name:SANOFI-AVENTIS OTC
    Full Title: Efficacy evaluation of Enterogermina, 2 billion Bacillus clausii spores, on eradication of small intestinal bacterial overgrowth a randomised, parallel-group, open study
    Medical condition: irritable bowel syndrome according to Rome II criteria and small intestinal bacterial overgrowth
    Disease: Version SOC Term Classification Code Term Level
    6.1 10023003 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-002482-39 Sponsor Protocol Number: PM L 0199 Start Date*: 2006-10-20
    Sponsor Name:SANOFI-AVENTIS OTC
    Full Title: Evaluation of the effects of Enterogermina, 2 billion Bacillus clausii spores, on the intestinal flora of children antibiotic treated for bacterial upper respiratory tract infections open, pilot s...
    Medical condition: Subjects with persistency of symptoms and requiring antibiotics for bacterial upper respiratory tract infections, i.e. complicated acute otitis media diagnosed by otoscopic examination or beta-ha...
    Disease: Version SOC Term Classification Code Term Level
    6.1 10017947 SOC
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004519-31 Sponsor Protocol Number: ENTERL08784 Start Date*: 2019-01-31
    Sponsor Name:Sanofi
    Full Title: Randomized, placebo-controlled, clinical trial to evaluate the efficacy of probiotic Bacillus clausii in the treatment of pediatric patients with irritable bowel syndrome
    Medical condition: Irritable bowel syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10023003 Irritable bowel syndrome PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-005939-15 Sponsor Protocol Number: DC04/RUP/3/08 Start Date*: 2009-02-11
    Sponsor Name:J. Uriach y Compañía, S.A.
    Full Title: Efficacy and safety of rupatadine in persistent allergic rhinitis and health-related quality of life in children age 6-11 years: A randomized, double blind, placebo-controlled clinical trial.
    Medical condition: Persistent Allergic Rhinitis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10034382 Perennial allergic rhinitis LLT
    9.1 10039776 Seasonal allergic rhinitis LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    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-Sat May 10 22:29:30 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA