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Clinical trials for Bile Acid Malabsorption

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    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).

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    17 result(s) found for: Bile Acid Malabsorption. Displaying page 1 of 1.
    EudraCT Number: 2019-004600-35 Sponsor Protocol Number: 70880 Start Date*: 2020-02-25
    Sponsor Name:Department of Hepatology and Gastroenterology, Aarhus University Hospital
    Full Title: Fat-reduced diet vs. bile acid binder as a treatment for bile acid malabsorption in patients with chronic diarrhoea as a late side effect after cancer treatment in the pelvic region - a randomised,...
    Medical condition: Bile acid malabsorption as a late side effect to cancer treatment in the pelvic region.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10080051 Bile acid diarrhoea LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-003192-30 Sponsor Protocol Number: CLJN452X2202 Start Date*: 2016-03-11
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A double blind, randomized placebo controlled crossover multiple dose study of LJN452 to assess safety, tolerability and efficacy in patients with primary bile acid diarrhea (pBAD).
    Medical condition: primary bile acid diarrhea
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10032786 Other specified intestinal malabsorption LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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: 2011-004491-10 Sponsor Protocol Number: CAC-001-01 Start Date*: 2011-10-06
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: An Open-Label, Single-Center, Nonrandomized Study to Compare the Therapeutic Efficacy of To Be Marketed (TBM) Cholic Acid Capsules with that of the Currently Used (CU) Formulation of Cholic Acid Ca...
    Medical condition: Patients with inborn errors of bile acid synthesis and metabolism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10070882 Inborn error in primary bile acid synthesis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    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: 2011-004528-36 Sponsor Protocol Number: CAC-002-01 Start Date*: 2011-10-06
    Sponsor Name:Asklepion Pharmaceuticals, LLC
    Full Title: An open-label, single center, non-randomized, continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis.
    Medical condition: Patients with inborn errors of bile acid synthesis and metabolism
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10070882 Inborn error in primary bile acid synthesis PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    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: 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: 2004-001054-84 Sponsor Protocol Number: 2004/W/GI/02 Start Date*: 2005-02-16
    Sponsor Name:NHS Lothian- University Hospitals Division
    Full Title: A comparison of the efficacy of dietary hydroxypropylcellulose and questran as therapeutic agents in bile acid induced diarrhoea
    Medical condition: these patients will have bile acid induced diarrhoea identified by an increased serum 7a-OH-cholestenone. and will have a history of one of 1. ileal resection 2. idiopathic bile acid diarrhoea.3. ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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: 2009-010727-91 Sponsor Protocol Number: 00695 Start Date*: 2011-03-01
    Sponsor Name:LMU München, Campus Großhadern
    Full Title: Colesevelam for the treatment of bile acid malabsorption in patients with Crohn’s disease (Colesevelam für die Therapie der Gallensäuren-Malabsorption bei M. Crohn-Patienten)
    Medical condition: Morbus Crohn
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    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: 2016-004692-53 Sponsor Protocol Number: SJ-434 Start Date*: 2017-03-01
    Sponsor Name:Zealand University Hospital Køge
    Full Title: Changes in bile acid homeostasis and stool habits after cholecystectomy
    Medical condition: Post cholecystectomy bile acid diarrhoea/malabsorption
    Disease: Version SOC Term Classification Code Term Level
    19.1 10017947 - Gastrointestinal disorders 10069703 Bile acid malabsorption PT
    19.1 10042613 - Surgical and medical procedures 10008611 Cholecystectomy PT
    19.1 10017947 - Gastrointestinal disorders 10066557 Chronic diarrhoea LLT
    19.1 10019805 - Hepatobiliary disorders 10057229 Post cholecystectomy syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-000825-35 Sponsor Protocol Number: U1111-1167-2731 Start Date*: 2015-08-27
    Sponsor Name:Rigshospitalet Blegdamsvej
    Full Title: The effect of the glucagon-like peptide-1 analogue, liraglutide (Victoza®), on jejunostomy output and intestinal absorption in short bowel syndrome patients, a double-blind cross-over study
    Medical condition: Short bowel syndrome (SBS) is a clinical situation with reduced absorptive mucosal surface due to extensive surgical resection. SBS leads to increased intestinal losses of fluids and electrolytes; ...
    Disease: Version SOC Term Classification Code Term Level
    19.1 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-004419-32 Sponsor Protocol Number: PMS-2018-002 Start Date*: 2019-10-03
    Sponsor Name:Pharmascience Inc.
    Full Title: A Phase IIa, Proof of Concept, Randomized, Double-Blind, Dose-Finding, Cross-Over Study of the Efficacy, Safety and Tolerability of a New Enteric-Coated Cholestyramine Capsule in Adult Short Bowel ...
    Medical condition: Bile-acid induced diarrhea in adult patients with Short Bowel Syndrome (SBS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10049416 Short-bowel syndrome PT
    20.1 10017947 - Gastrointestinal disorders 10080049 Bile acid diarrhea LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    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)
    EudraCT Number: 2011-004287-30 Sponsor Protocol Number: LAL-CL06 Start Date*: 2014-06-19
    Sponsor Name:Alexion Pharmaceuticals inc
    Full Title: A Multicenter, Open-Label Study of Sebelipase Alfa in Patients with Lysosomal Acid Lipase Deficiency
    Medical condition: Lysosomal Acid Lipase Deficiency (LALD)
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10024579 Lysosomal storage disorders HLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed) ES (Completed) GB (Completed) IT (Prematurely Ended) DE (Completed) BE (Completed) HR (Completed) NL (Completed)
    Trial results: View results
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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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