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Clinical trials for Antibiotic-associated diarrhea

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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    10 result(s) found for: Antibiotic-associated diarrhea. Displaying page 1 of 1.
    EudraCT Number: 2012-001542-18 Sponsor Protocol Number: AAD-EU2012 Start Date*: 2012-07-12
    Sponsor Name:DuPont Nutrition and Health Active Nutrition
    Full Title: Effect of a probiotic formula on reducing the risk for antibiotic-associated diarrhea
    Medical condition: Antibiotic-associated diarrhea
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004856 10002739 Antibiotic-associated diarrhea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    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: 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: 2009-017374-20 Sponsor Protocol Number: BNI-2009-01 Start Date*: 2010-04-19
    Sponsor Name:Bernhard-Nocht-Institute for Tropical Medicine
    Full Title: Probiotic Saccharomyces boulardii for the prevention of antibiotic-associated diarrhoea – randomised, double-blind, placebo-controlled trial
    Medical condition: Antibiotic - associated - Diarrhoea (AAD) Clostridium difficile - associated - Diarrhoea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10012748 Diarrhoea, Clostridium difficile LLT
    14.1 10021881 - Infections and infestations 10006835 C.difficile diarrhoea LLT
    14.1 10017947 - Gastrointestinal disorders 10055956 Antibiotic-associated diarrhoea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2006-000500-16 Sponsor Protocol Number: MU0524 Start Date*: 2006-09-13
    Sponsor Name:Ardeypharm GmbH
    Full Title: E. coli Stamm Nissle 1917 zur Behandlung des postinfektiösen/Antibiotika-assoziierten Reizdarmsyndroms mit Diarrhö E. coli strain Nissle 1917 for the treatment of post-infectious/antibiotic-associ...
    Medical condition: postinfectious/antibiotic-associated Irritable Bowel Syndrome with diarrhea
    Disease: Version SOC Term Classification Code Term Level
    8.1 10060845 Diarrhea predominant irritable bowel syndrome LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-006269-17 Sponsor Protocol Number: SPON1069-11 Start Date*: 2012-11-16
    Sponsor Name:Cardiff University, Research & Development Commercial Department
    Full Title: A double blind placebo controlled randomised clinical trial to study the effect of Probiotics for the prevetion or amelioration of Antibiotic Associated Diarrhoea in residents of care homes in Sout...
    Medical condition: Antibiotic Associated Diarrhoea
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10055956 Antibiotic-associated diarrhoea LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010713-69 Sponsor Protocol Number: LINPT01 Start Date*: 2009-05-13
    Sponsor Name:Lek Pharmaceuticals d.d.
    Full Title: Randomized, placebo controlled, double-blind, parallel group, multicentric Phase IV study on the clinical efficacy of lactic acid bacteria in form of hard capsules (capsule contains not less than 2...
    Medical condition: Antibiotic associated diarrhea
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: View results
    EudraCT Number: 2015-002346-32 Sponsor Protocol Number: SB-2-004-005 Start Date*: 2015-11-27
    Sponsor Name:Synthetic Biologics, Inc.
    Full Title: A Phase 2b Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study of SYN-004 Compared to Placebo for the Prevention of Clostridium difficile Associated Diarrhea in Patients with a Diag...
    Medical condition: Prevention of Clostridium difficile infection (CDI), Clostridium difficile associated diarrhea (CDAD), antibiotic-associated diarrhea (AAD) and secondary infections with healthcare-acquired drug-re...
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10006834 C.difficile diarrhea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-002823-27 Sponsor Protocol Number: GAVALAGG Start Date*: 2016-11-17
    Sponsor Name:INFECTOPHARM Arzneimittel GmbH
    Full Title: Placebo-kontrollierte, multizentrische, randomisierte, doppelblinde Phase III-Studie zur Verbesserung der gastrointestinalen Verträglichkeit einer per-oralen Antibiotikatherapie durch add-on-Gabe v...
    Medical condition: Verbesserung der gastrointestinalen Verträglichkeit einer per-oralen Antibiotikatherapie
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10055956 Antibiotic-associated diarrhoea LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-002876-32 Sponsor Protocol Number: AAD-CDD-001 Start Date*: 2008-10-06
    Sponsor Name:University of Wales Swansea
    Full Title: A multicentre, randomised, placebo controlled trial of lactic acid bacteria in the prevention of antibiotic-associated diarrhoea (AAD) and Clostridium difficile diarrhoea (CDD) in patients aged 65 ...
    Medical condition: AAD is diarrhoea occurring in association with antibiotic treatment without an alternative cause. It occurs typically 2-8 weeks after exposure to antibiotics. The frequency of AAD varies markedly b...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10064065 Prophylaxis against diarrhoea PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (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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