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Clinical trials for SeHCAT

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   44338   clinical trials with a EudraCT protocol, of which   7368   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.
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    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.
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    10 result(s) found for: SeHCAT. Displaying page 1 of 1.
    EudraCT Number: 2016-002217-22 Sponsor Protocol Number: SJ-546 Start Date*: 2016-09-02
    Sponsor Name:Sjællands University Hospital, Køge
    Full Title: Validation of stimulated ∆FGF19 for diagnosing bile acid diarrhoea
    Medical condition: Bile acid malabsorption / bile acid diarrhoea
    Disease: Version SOC Term Classification Code Term Level
    19.1 10017947 - Gastrointestinal disorders 10069703 Bile acid malabsorption PT
    19.1 10017947 - Gastrointestinal disorders 10066557 Chronic diarrhoea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2018-003575-34 Sponsor Protocol Number: 301084 Start Date*: 2018-11-29
    Sponsor Name:Professor, Ph.d. MD. Filip Krag Knop
    Full Title: Treatment of bile acid malabsorption with liraglutid
    Medical condition: Bile acid malabsoprtion is a disease in which there is a large spill-over of bileacids to the larger intestines. This causes watery diarrheas and abdominal symptoms.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10080051 Bile acid diarrhoea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2016-001452-22 Sponsor Protocol Number: SJ-641 Start Date*: 2018-08-29
    Sponsor Name:Zealand University Hospital
    Full Title: Treatment effect of colesevelam for bile acid diarrhoea
    Medical condition: Bile acid diarrhoea
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10069703 Bile acid malabsorption PT
    20.1 10017947 - Gastrointestinal disorders 10066557 Chronic diarrhoea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-003777-28 Sponsor Protocol Number: OBADIAH1 Start Date*: 2012-04-26
    Sponsor Name:Imperial College London and Imperial College Healthcare NHS Trust
    Full Title: Obeticholic acid treatment in patients with bile acid diarrhoea: an open-label, pilot study of mechanisms, safety and symptom response.
    Medical condition: Bile acid diarrhoea (also known as bile acid malabsorption)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-011149-14 Sponsor Protocol Number: CLT-DC/00/001 Start Date*: 2010-02-03
    Sponsor Name:Servicio de Gastroenterología del Hospital Universitario Mútua de Terrassa
    Full Title: Estudio multicéntrico doble ciego controlado con placebo para valorar la eficacia de la colestiramina en el tratamiento de la diarrea crónica acuosa atribuida a la malabsorción de ácidos biliares
    Medical condition: Presencia de diarrea acuosa de características funcionales y origen incierto
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001531-32 Sponsor Protocol Number: Obadiah-2 Start Date*: 2019-12-20
    Sponsor Name:Imperial College Healthcare NHS Trust
    Full Title: OBADIAH-2: A randomised, double-blind, placebo-controlled trial of two doses of obeticholic acid and placebo in patients with primary bile acid diarrhoea
    Medical condition: Bile acid diarrhoea (also known as bile acid malabsorption)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10080051 Bile acid diarrhoea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2013-002924-17 Sponsor Protocol Number: A3384-001 Start Date*: 2014-01-27
    Sponsor Name:Albireo AB
    Full Title: A double-blind, randomized, placebo-controlled, study to demonstrate the efficacy and safety of 250 mg or 1 g A3384 administered orally twice daily for two weeks to patients with Bile Acid Malabsor...
    Medical condition: Patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-002762-12 Sponsor Protocol Number: SJ-674 Start Date*: 2021-12-07
    Sponsor Name:Zealand University Hospital
    Full Title: The prevalence of bile acid diarrhéa and the effect of budesonid on the bile acid homeostasis in patients with microscopic colitis
    Medical condition: Microscopic colitis Bile acid diarrhea
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (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: 2017-000533-31 Sponsor Protocol Number: 17GA001 Start Date*: 2017-11-07
    Sponsor Name:Nottingham University Hospitals NHS Trust
    Full Title: TReatment of Irritable bowel syndrome using Titrated ONdansetron Trial
    Medical condition: Irritable Bowel Syndrome with Diarrhoea
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10060845 Diarrhea predominant irritable bowel syndrome LLT
    21.1 100000004856 10060849 Diarrhoea predominant irritable bowel syndrome LLT
    Population Age: Adults, 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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