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Clinical trials for Bile Salt

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    13 result(s) found for: Bile Salt. Displaying page 1 of 1.
    EudraCT Number: 2020-001961-34 Sponsor Protocol Number: RDG-1/PBC Start Date*: 2021-02-02
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of RhuDex granules with placebo in the treatment of primary biliary cholangitis
    Medical condition: Primary biliary cholangitis
    Disease: Version SOC Term Classification Code Term Level
    21.0 10019805 - Hepatobiliary disorders 10080429 Primary biliary cholangitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) HU (Prematurely Ended) SK (Prematurely Ended) NL (Prematurely Ended) BE (Completed) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-002434-10 Sponsor Protocol Number: BVT.BSSL-021 Start Date*: 2007-10-17
    Sponsor Name:Biovitrum AB (publ.)
    Full Title: A prospective, randomised, double-blind crossover study comparing 0.15 g/L rhBSSL added to pasteurized breast milk versus placebo during one week of treatment in preterm infants born before week 32...
    Medical condition: Enzyme replacement therapy in pre-term infants. Reduced fat uptake capabilities due to prematurity of pre-term infants
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-010163-16 Sponsor Protocol Number: 08/0285 Start Date*: 2009-06-05
    Sponsor Name:University College London
    Full Title: Bile salt manipulation as a novel treatment for Crohn’s disease: a single centre open label pilot study of atorvastatin and colesevalam in patients with active ileal Crohn’s disease
    Medical condition: Active Crohn's disease affecting the ileum
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011406 Crohn's ileitis LLT
    9.1 10058815 Crohn's disease acute episode LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003631-37 Sponsor Protocol Number: UDC1 Start Date*: 2017-01-24
    Sponsor Name:Universitaire ziekenhuis Leuven
    Full Title: Therapeutic effect of ursodeoxycholic acid on duodenal permeability and meal related sensory motor function in functional dyspepsia patients
    Medical condition: Functional dyspepsia (FD)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023909-35 Sponsor Protocol Number: BVT.BSSL-030 Start Date*: 2011-06-24
    Sponsor Name:Swedish Orphan Biovitrum AB (publ)
    Full Title: A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Wee...
    Medical condition: Prevention of growth retardation due to lack of bile salt-stimulated lipase in enteral nutrition
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036590 Premature baby PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Prematurely Ended) SE (Prematurely Ended) DE (Prematurely Ended) HU (Completed) FR (Ongoing) CZ (Completed) PL (Prematurely Ended) ES (Prematurely Ended) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001317-28 Sponsor Protocol Number: ABBA-2 Start Date*: 2015-07-30
    Sponsor Name:UMC Utrecht
    Full Title: A B2-agonist as a CFTR activator in CF - Part 2
    Medical condition: Cystic fibrosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-001642-10 Sponsor Protocol Number: SMT19969/C005 Start Date*: 2019-03-13
    Sponsor Name:Summit (Oxford) Limited
    Full Title: A Phase 3, randomized, double-blind, active controlled study to compare the efficacy and safety of ridinilazole (200 mg, bid) for 10 days with vancomycin (125 mg, qid) for 10 days in the treatment ...
    Medical condition: Clostridium difficile infection (CDI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LV (Completed) LT (Completed) BE (Prematurely Ended) DE (Completed) CZ (Completed) ES (Ongoing) FR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2009-013348-35 Sponsor Protocol Number: 7915 Start Date*: 2009-08-04
    Sponsor Name:University Medical Center Utrecht
    Full Title: (Patho)Physiological aspects of the bile salt-FXR-FGF19-axis: potential consequences in Crohn's disease.
    Medical condition: Patients with quiescent Crohn’s colitis, defined as a Crohn’s Disease Activity Index <150 ; non-IBD patients will serve as disease controls.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011400 Crohn's colitis LLT
    9.1 10011401 Crohn's disease LLT
    9.1 10011402 Crohn's disease (colon) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-002423-33 Sponsor Protocol Number: BVT.BSSL-020 Start Date*: 2007-10-30
    Sponsor Name:BIOVITRUM AB
    Full Title: A prospective, randomised, double-blind crossover study comparing 0.15 g/L rhBSSL added to infant formula versus placebo during one week of treatment in preterm infants born before week 32 of gesta...
    Medical condition: Enzyme replacement therapy in pre-term infants. Reduced fad uptake capabilities due to prematurity of pre-term infants
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013317 Lipid metabolism disorders HLGT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-002833-13 Sponsor Protocol Number: AMT-101-203 Start Date*: 2021-02-05
    Sponsor Name:Applied Molecular Transport Inc.
    Full Title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination with Adalimumab in Subjects with Moderate to Sev...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-000824-17 Sponsor Protocol Number: BT-11-202 Start Date*: 2021-05-26
    Sponsor Name:Landos Biopharma Inc.
    Full Title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Moderate to Severe Crohn’s Disease
    Medical condition: Patients with Crohn's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended) AT (Prematurely Ended) SK (Prematurely Ended) HR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000047-31 Sponsor Protocol Number: AMT-101-202 Start Date*: 2020-08-03
    Sponsor Name:Applied Molecular Transport Inc.
    Full Title: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) HU (Completed) DE (Completed) BG (Completed) IT (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-005086-39 Sponsor Protocol Number: BT-11-201 Start Date*: 2019-10-28
    Sponsor Name:Landos Biopharma Inc.
    Full Title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Efficacy and Safety of Oral BT-11 in Mild to Moderate Ulcerative Colitis
    Medical condition: Mild to Moderate Ulcerative Colitis Inflammatory bowel disease (IBD) is an autoimmune disease of the gastrointestinal (GI) tract with unknown etiology that encompasses 2 primary clinical manifesta...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10009900 Colitis ulcerative PT
    20.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) HR (Completed) BG (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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