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Clinical trials for Bacillus

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   44334   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 ).  
     
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    74 result(s) found for: Bacillus. Displaying page 1 of 4.
    1  2  3  4  Next»
    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: 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: 2020-000970-10 Sponsor Protocol Number: LPS16140 Start Date*: 2020-09-09
    Sponsor Name:Sanofi Aventis Groupe
    Full Title: Phase III, randomized, double blind, parallel groups, clinical trial to evaluate the efficacy and safety of Bacillus clausii versus placebo in the prevention of antibiotic associated diarrhea (AAD)...
    Medical condition: Antibiotic associated diarrhea (AAD) in children
    Disease: Version SOC Term Classification Code Term Level
    21.0 10042613 - Surgical and medical procedures 10064065 Prophylaxis against diarrhoea PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    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: 2017-004540-37 Sponsor Protocol Number: MITOBCG Start Date*: 2018-10-11
    Sponsor Name:AZIENDA OSPEDALIERA SANT'ANDREA
    Full Title: The effects of sequential Mitomycin and Bacillus Calmette-Guérin treatment versus Bacillus Calmette-Guérin monotherapy in patients with High risk Non-Muscle Invasive Bladder Cancer
    Medical condition: patients with High grade Non-Muscle Invasive Bladder Cancer with high progression risk
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10038364 Renal and urinary tract neoplasms malignant and unspecified HLGT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-001355-12 Sponsor Protocol Number: LPS15198 Start Date*: 2019-02-27
    Sponsor Name:SANOFI-AVENTIS GROUPE
    Full Title: 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 intest...
    Medical condition: Small intestinal bacterial overgrowth (SIBO)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071061 Small intestinal bacterial overgrowth LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (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: 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: 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: 2011-000607-41 Sponsor Protocol Number: MMC-BCG-1 Start Date*: 2011-03-04
    Sponsor Name:Centre Hospitalier de Jolimont-Lobbes-Tubize-Nivelles
    Full Title: A phase I/II multicentric Belgian prospective novel sequential chemo-immunotherapy regimen for adjuvant treatment in non-muscle invasive bladder cancer.
    Medical condition: Patients with intermediate/high risk non-muscle invasive bladder cancer (NMIBC) • intermediate risk tumours – Ta, T1 Grade 1, Grade 2, multifocal and tumours larger than 3 cm • high risk tumours – ...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-000596-87 Sponsor Protocol Number: ACTIVATE Start Date*: 2017-05-26
    Sponsor Name:Hellenic Institute for the Study of Sepsis
    Full Title: A RANDOMIZED CLINICAL TRIAL FOR ENHANCED TRAINED IMMUNE RESPONSES THROUGH BACILLUS CALMETTE-GUÉRIN VACCINATION TO PREVENT INFECTIONS OF THE ELDERLY: THE ACTIVATE TRIAL
    Medical condition: Vaccination for infection prevention
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004865 10036897 Prophylactic vaccination LLT
    19.1 100000004865 10046859 Vaccination LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    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: 2020-001591-15 Sponsor Protocol Number: NL73430.091.20 Start Date*: 2020-04-09
    Sponsor Name:Radboudumc
    Full Title: Reducing hospital admission of elderly in SARS-CoV-2 pandemic via the induction of trained immunity by bacillus Calmette-Guérin vaccination, a randomized controlled trial.
    Medical condition: SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10047490 Virus identification and serology HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-003904-15 Sponsor Protocol Number: 20202407 Start Date*: 2020-08-27
    Sponsor Name:University of Southern Denmark
    Full Title: Using BCG vaccine to enhance non-specific protection of senior citizens during the COVID-19 pandemic. A randomized clinical trial.
    Medical condition: Healthy volunteers, senior citizens of 65 years or older. Immune system activation after BCG vaccination. Acute infections, COVID-19 and self-reported respiratory illness will be monitored.
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084382 Coronavirus disease 2019 LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2018-001967-22 Sponsor Protocol Number: MK-3475-676 Start Date*: 2018-11-27
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination with Bacillus Calmette-Guerin (BCG) in Participants with High-...
    Medical condition: High-risk Non-muscle Invasive Bladder Cancer (NMIBC)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10022877 Invasive bladder cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) FI (Trial now transitioned) GB (GB - no longer in EU/EEA) DE (Trial now transitioned) AT (Ongoing) PT (Trial now transitioned) IT (Trial now transitioned) PL (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned) HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-003581-27 Sponsor Protocol Number: CA209-9UT Start Date*: 2020-07-03
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 2, Randomized, Open-label Study of Nivolumab or Nivolumab/BMS-986205 Alone or Combined with Intravesical BCG in Participants with BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Ca...
    Medical condition: BCG-Unresponsive, High-Risk, Non-Muscle Invasive Bladder Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005005 Bladder cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) ES (Prematurely Ended) GB (GB - no longer in EU/EEA) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000150-22 Sponsor Protocol Number: T14/2018 Start Date*: 2018-06-05
    Sponsor Name:Turku University Hospital
    Full Title: Intravesical instillation therapy with bacillus Calmette-Guérin (BCG) and sequential BCG and electromotive Mitomycin-C (EMDA-MCC) in patients with high risk non-muscle-invasive bladder carcinoma
    Medical condition: Non-muscle invasive bladder cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000919-69 Sponsor Protocol Number: 73249 Start Date*: 2020-03-17
    Sponsor Name:University Medical Center
    Full Title: Reducing health care workers absenteeism in SARS-CoV-2 pandemic by enhanced trained immune responses through Bacillus Calmette-Guérin vaccination, a randomized controlled trial (COVID-19).
    Medical condition: SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10047490 Virus identification and serology HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2020-001888-90 Sponsor Protocol Number: 20201504 Start Date*: 2020-04-30
    Sponsor Name:University of Southern Denmark
    Full Title: Using BCG vaccine to enhance non-specific protection of health care workers during the COVID-19 pandemic. A randomised controlled multi-center trial.
    Medical condition: Healthy volunteers, health care workers. Immune system activation after BCG vaccination. Work absenteeism and COVID-19 will be monitored.
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10053983 Corona virus infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2020-001678-31 Sponsor Protocol Number: APHP200462 Start Date*: 2020-04-28
    Sponsor Name:Assistance Publique Hopitaux de Paris
    Full Title: Randomized controlled trial evaluating the efficacy of vaccination with Bacillus Calmette and Guérin (BCG) in the Prevention of COVID-19 via the strengthening of innate immunity in Health Care Work...
    Medical condition: COVID 19 Health care workers (medical or non-medical) in French hospitals in direct contact with COVID-19 patients, including nurses, medical doctors and other personnel working in wards in charge...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
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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
    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.

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