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Clinical trials for FMT

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
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    • 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   43851   clinical trials with a EudraCT protocol, of which   7283   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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    18 result(s) found for: FMT. Displaying page 1 of 1.
    EudraCT Number: 2015-005753-12 Sponsor Protocol Number: RG_15-026 Start Date*: 2017-11-22
    Sponsor Name:University of Birmingham
    Full Title: Prospective, open-label, randomised pilot study to assess two possible routes of Faecal Microbiota Transplant (FMT) delivery in patients with ulcerative colitis.
    Medical condition: Ulcerative colitis for at least 3 months prior to trial entry
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2017-002697-39 Sponsor Protocol Number: MPOH03 Start Date*: 2019-01-11
    Sponsor Name:MaaT Pharma
    Full Title: Treatment of steroid refractory gastro-intestinal acute graft-versus-Host disEase afteR AllogeneiC hematopoietic stem celL transplantation with fEcal microbiota transfer (HERACLES)
    Medical condition: Steroid refractory gastro-intestinal acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FR (Completed) PL (Prematurely Ended) GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-001852-41 Sponsor Protocol Number: GLP1-FMT Start Date*: 2022-09-06
    Sponsor Name:Radboud university medical center
    Full Title: BetaFIT study: Beta cell imaging after Faecal mIcrobiota Transplantation
    Medical condition: Type 1 diabetes
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001618-41 Sponsor Protocol Number: FERARO Start Date*: 2020-04-14
    Sponsor Name:Guy's and St Thomas NHS Foundation Trust
    Full Title: FERARO: A prospective, randomised placebo controlled feasibility trial of Faecal microbiota Transplant to ERadicate gastrointestinal carriage of Antibiotic Resistant Organisms
    Medical condition: Gastrointestinal colonisation and infection with Extended Spectrum Beta-lactamase (ESBL) producing Enetrobacteriales and Carbapenemase Producing Enetrobacteriales
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10004052 Bacterial resistance LLT
    20.1 10021881 - Infections and infestations 10034133 Pathogen resistance PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-004233-16 Sponsor Protocol Number: CA-209-7HP Start Date*: 2021-05-30
    Sponsor Name:Medical University of Graz
    Full Title: INDUCING REMISSION IN MELANOMA PATIENTS WITH CHECKPOINT INHIBITOR THERAPY USING FECAL MICROBIOTA TRANSPLANTATION.
    Medical condition: Malignant melanoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10025650 Malignant melanoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2021-004924-14 Sponsor Protocol Number: BSTEP Start Date*: 2022-04-21
    Sponsor Name:Leiden University Medical Center
    Full Title: New treatment strategy for patients with multiple recurrent Clostridioides difficile infection with bezlotoxumab as first option
    Medical condition: recurrent C. difficile infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10009657 Clostridium difficile colitis PT
    20.0 10021881 - Infections and infestations 10012748 Diarrhoea, Clostridium difficile LLT
    20.0 10021881 - Infections and infestations 10012734 Diarrhea, Clostridium difficile LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-004402-10 Sponsor Protocol Number: APHP180587 Start Date*: 2020-03-11
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Fecal transplantation to Eradicate Colonizing Emergent Superbugs
    Medical condition: Patients colonized with MDR-GNB (multi-drug resistant Gram Negative bacteria )
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10028152 Multi-antibiotic resistance LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003629-13 Sponsor Protocol Number: PROFIT Start Date*: 2018-01-31
    Sponsor Name:King's College London [...]
    1. King's College London
    2. King's College Hospital NHS Fundation Trust
    Full Title: A Prospective, randomised placebo controlled feasibility trial of Faecal Microbiotica Transplantation in cirrhosis
    Medical condition: Cirrhosis of the liver
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10024667 Liver cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    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 (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003727-22 Sponsor Protocol Number: CER13266 Start Date*: 2015-05-26
    Sponsor Name:Geneva University Hospitals
    Full Title: A randomized controlled multicenter trial of a five day course of oral colistin and neomycin followed by restoration of the gut microbiota using fecal transplantation to eradicate intestinal carr...
    Medical condition: Intestinal colonization with extended-spectrum beta-lactamse or carbapenemase producing enterobacteriaceae
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    18.1 100000004862 10069718 Bacterial colonization LLT
    18.1 100000004862 10028152 Multi-antibiotic resistance LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003062-82 Sponsor Protocol Number: RBI/FMT-CDI Start Date*: 2016-11-01
    Sponsor Name:Department of Medicine, Zealand University Hospital
    Full Title: Rectal Bacteriotherapy, Faecal microbiota transplantation or oral vancomycin for the treatment of recurrent Clostridium Difficile infection: A randomised controlled trial
    Medical condition: Recurrent infection with Clostridium Difficile
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10072994 Clostridium difficile infection recurrence LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-000234-42 Sponsor Protocol Number: FAB0001 Start Date*: 2022-05-27
    Sponsor Name:Medical University of Vienna, Div. of Gastroenterology & Hepatology
    Full Title: Fecal Microbiota Transplant (FMT) combined with Atezolizumab plus Bevacizumab in Patients with HepatoCellular Carcinoma who failed to respond to prior Immunotherapy – the FAB-HCC Trial
    Medical condition: Hepatocellular carcinoma
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10049010 Carcinoma hepatocellular LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-003816-29 Sponsor Protocol Number: APHP190183 Start Date*: 2019-12-16
    Sponsor Name:ASSISTANCE PUBLIQUE -HOPITAUX DE PARIS (AP-HP)
    Full Title: Fecal microbiota transplantation in Crohn’s disease as relay after anti-TNF withdrawal
    Medical condition: Adult patients with Crohn’s disease diagnosed for at least 6 months and healthy volunteers donors
    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: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-002528-17 Sponsor Protocol Number: AC-061A301 Start Date*: 2014-03-14
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A multi-center, randomized, double-blind study to compare the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD)
    Medical condition: Clostridium difficile-associated diarrhea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Completed) PL (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-002508-15 Sponsor Protocol Number: AC-061A302 Start Date*: 2014-03-03
    Sponsor Name:Actelion Pharmaceuticals Ltd
    Full Title: A multi-center, randomized, double-blind study to compare the efficacy and safety of cadazolid versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD)
    Medical condition: Clostridium difficile-associated diarrhea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) HU (Completed) SK (Completed) GR (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2018-004580-31 Sponsor Protocol Number: COLONIZE Start Date*: 2019-03-21
    Sponsor Name:Oslo University Hospital
    Full Title: Comparative effectiveness of intestinal microbiota versus vancomycin for primary Clostridium difficile infection – randomized trials.
    Medical condition: Clostridium difficile infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003004-24 Sponsor Protocol Number: 2015-003004-24 Start Date*: 2015-11-13
    Sponsor Name:Aarhus University Hospital
    Full Title: Faecal microbiota transplantation for relapsing Clostridium difficile infection
    Medical condition: Relapsing Clostridium difficile infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10009657 Clostridium difficile colitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-001900-76 Sponsor Protocol Number: PRASCO Start Date*: 2015-08-25
    Sponsor Name:UMBERTO I - POLICLINICO DI ROMA
    Full Title: Manipulating the microbiome in IBD by antibiotics and fecal microbiota transplantation (FMT): a randomized controlled trial
    Medical condition: Acute Severe colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045283 UC aggravated LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    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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