Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Pouchitis

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    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.
    Advanced Search: Search tools
     
    13 result(s) found for: Pouchitis. Displaying page 1 of 1.
    EudraCT Number: 2009-015136-14 Sponsor Protocol Number: FP-0110-201 Start Date*: 2009-11-20
    Sponsor Name:FORMAC Pharmaceuticals NV
    Full Title: Modified release metronidazole for the treatment of pouchitis after colectomy with ileo-anal pouch anastomosis for ulcerative colitis: a pharmacokinetic study
    Medical condition: Pouchitis
    Disease: Version SOC Term Classification Code Term Level
    12.0 10036463 Pouchitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-004268-31 Sponsor Protocol Number: 20110118 Start Date*: 2011-12-13
    Sponsor Name:Odense University Hospital
    Full Title: Adalimumab (Humira) in the treatment of chronic pouchitis
    Medical condition: Chronic pouchitis after proctocolectomy and reconstruction with a J-pouch and with ulcerative colitis as primary diagnosis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-002952-34 Sponsor Protocol Number: ACH-UCP-301 Start Date*: 2015-12-07
    Sponsor Name:Atlantic Pharmaceuticals Limited
    Full Title: A Randomised, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Topical Alicaforsen Enema in Subjects with Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis
    Medical condition: Active, Chronic, Antibiotic Refractory Primary Idiopathic Pouchitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) NL (Completed) IE (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-006656-14 Sponsor Protocol Number: MH002-PC-201 Start Date*: 2022-06-22
    Sponsor Name:MRM Health NV
    Full Title: Exploratory Study to Evaluate Safety, Mechanistic and Clinical Effects of MH002 in Subjects with Acute Pouchitis
    Medical condition: Acute Pouchitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-005694-87 Sponsor Protocol Number: UCDCRC/21/01 Start Date*: 2022-10-25
    Sponsor Name:University College Dublin
    Full Title: A Randomised Pilot Study of the Safety and Efficacy of Tofacitinib (Xeljanz) in Improving Endoscopic Outcomes in Subjects with Ulcerative Colitis with Active, Chronic, Antibiotic Dependent or Refra...
    Medical condition: Subjects with Ulcerative Colitis with Active, Chronic, Antibiotic Dependent or Refractory Idiopathic Pouchitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000609-10 Sponsor Protocol Number: 2020-01-GMF-1 Start Date*: 2021-07-06
    Sponsor Name:Center for Surgical Science
    Full Title: A combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgery A clinical safety and proof-of-con...
    Medical condition: A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003472-78 Sponsor Protocol Number: Vedolizumab-4004 Start Date*: 2016-09-02
    Sponsor Name:Takeda Development Centre Europe, Ltd.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Phase 4 Study to Evaluate the Efficacy and Safety of Entyvio (Vedolizumab IV) in the Treatment of Chronic Pouchitis
    Medical condition: Chronic Pouchitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) BE (Completed) ES (Completed) NL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-000048-73 Sponsor Protocol Number: AMT-101-201 Start Date*: 2020-09-24
    Sponsor Name:Applied Molecular Transport Inc.
    Full Title: A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
    Medical condition: Pouchitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10036463 Pouchitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) HU (Completed) DE (Completed) NL (Completed) BE (Completed) IT (Completed) IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-007977-21 Sponsor Protocol Number: GS07/8360 Start Date*: 2008-11-12
    Sponsor Name:Leeds Teaching Hospitals Trust
    Full Title: ASSESSMENT OF THE ROLE OF THE PROBIOTIC VSL3® IN THE TREATMENT OF POUCHITIS AFTER ILEAL POUCH-ANAL ANASTOMOSIS
    Medical condition: This study aims to assess the bacterial flora in patients with healthy pouches and patients with have pouchitis. We aim to study the clinical and microbiological effectiveness of antibiotic and pro...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-004967-11 Sponsor Protocol Number: RC17_0021 Start Date*: 2018-06-26
    Sponsor Name:CHU Nantes
    Full Title: Poca
    Medical condition: Patients operated with an IPAA for Ulcerative Colitis with active recurrent pouchitis, who respond after 4 weeks of an antibiotherapy, will be randomized
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10000638 Active ileal inflammation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-002695-12 Sponsor Protocol Number: NL71383.018.20 Start Date*: 2020-10-14
    Sponsor Name:Amsterdam UMC, location AMC
    Full Title: Tofacitinib in the treatment of chronic, recurrent and/or antibiotic refractory pouchitis: a multi-omics approach
    Medical condition: Chronic, recurrent and/or antibiotic refractory pouchitis in patients with ulcerative colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-005642-37 Sponsor Protocol Number: sandopouch-01 Start Date*: 2007-04-10
    Sponsor Name:University of Leuven, Division of Gastroenterology
    Full Title: Sandostatin® in the treatment of diarrhea in patients with ileal pouch anal anastomosis.
    Medical condition: IPAA Pouchitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2019-003151-11 Sponsor Protocol Number: CNTO1275UCO2001 Start Date*: 2020-05-08
    Sponsor Name:UZ Leuven
    Full Title: Stelara fOr ChRonic AntibioTic rEfractory pouchitiS (SOCRATES): A Belgian open label multicenter pilot-study
    Medical condition: Chronic antibiotic refractory and relapsing pouchitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon May 05 14:11:47 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA