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Clinical trials for Gut flora

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   44335   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.
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    19 result(s) found for: Gut flora. Displaying page 1 of 1.
    EudraCT Number: 2006-004162-13 Sponsor Protocol Number: SAE-13/IBD Start Date*: 2007-02-27
    Sponsor Name:Charité Universitätsmedizin, Campus Charité Mitte
    Full Title: Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease
    Medical condition: Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10021972 Inflammatory bowel disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003378-28 Sponsor Protocol Number: 2013071339 Start Date*: 2014-04-09
    Sponsor Name:Department of Medicine, Køge University Hospital [...]
    1. Department of Medicine, Køge University Hospital
    2. Department of Medicine, Køge University Hospital
    Full Title: THE ROLE OF PHAGES IN MICROBIAL GUT ECOLOGY A STUDY OF INTERACTIONS BETWEEN ANTIBIOTICS AND THE GUT MICROBIOTA IN HEALTHY VOLUNTEERS A PARALLEL, SINGLE-BLIND, RANDOMIZED, CONTROLLED STUDY
    Medical condition: Resistance to anitbiotics
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004862 10004052 Bacterial resistance LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-000953-30 Sponsor Protocol Number: EPAAC Start Date*: 2019-07-25
    Sponsor Name:Uppsala University Hospital
    Full Title: Effects of phenoximetylpenicillin, amoxicillin and amoxicillin-clavulanic acid on the gut microbiota of healthy volunteers: a randomized clinical trail
    Medical condition: Effects of phenoximetylpenicillin, amoxicillin and amoxicillin-clavulanic acid on the gut microbiota of healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000192-27 Sponsor Protocol Number: GutHeart1 Start Date*: 2015-03-19
    Sponsor Name:Oslo University Hospital
    Full Title: GutHeart: Targeting Gut microbiota to treat Heart failure
    Medical condition: Heart failure
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001856-51 Sponsor Protocol Number: 12.007 Start Date*: 2014-08-26
    Sponsor Name:Aleksander Krag
    Full Title: Anti-fibrotic and molecular aspects of rifaximin in alcoholic liver disease: A randomized placebo controlled clinical trial
    Medical condition: Liver fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10016648 Fibrosis liver LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2019-004958-29 Sponsor Protocol Number: CHUBX2019/25 Start Date*: 2020-04-07
    Sponsor Name:CHU de Bordeaux
    Full Title: EFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDREN
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-000102-35 Sponsor Protocol Number: 35128 Start Date*: 2014-12-19
    Sponsor Name:Clinica Medica 5
    Full Title: Effect of administration "add on" of Rifaximin on portal hypertension of patients with liver cirrhosis and esophageal varices in standard therapy with propranolol
    Medical condition: Portal hypertension, liver cirrhosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-021515-17 Sponsor Protocol Number: N/A Start Date*: 2010-09-30
    Sponsor Name:Imperial College London
    Full Title: RiFL: Rifaxamin in Fatty Liver Disease. Does Modulation of Gut Microbiota Reduce Hepatic Inflammation in Non-Alcoholic Steatohepatitis (NASH)?
    Medical condition: Non-alcoholic steatohepatitis (NASH)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10053219 non-alcoholic steatohepatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004447-36 Sponsor Protocol Number: ZonMw848015005 Start Date*: 2017-06-23
    Sponsor Name:Stichting Rotterdams Onderzoeksconsortium Kindergeneeskunde
    Full Title: INTRAVENOUS-TO-ORAL ANTIBIOTIC SWITCH THERAPY FOR SUSPECTED NEONATAL BACTERIAL INFECTIONS: CLINICAL EFFICACY, SAFETY AND COST-EFFECTIVENESS
    Medical condition: Neonatal probable bacterial infection
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-005483-25 Sponsor Protocol Number: SMT19969/C003 Start Date*: 2014-10-08
    Sponsor Name:Summit (Oxford) Limited
    Full Title: A Phase II, Randomized, Open-Label, Active-Controlled Clinical Study to Investigate the Safety and Efficacy of SMT19969 (200 mg BID) for 10 days Compared with Fidaxomicin (200 mg BID) for 10 days f...
    Medical condition: Clostridium difficile infection
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-003171-29 Sponsor Protocol Number: VANCO-PK/IM_E:005/2015 Start Date*: 2015-12-17
    Sponsor Name:Universitätsklinikum Tübingen
    Full Title: The correlation between vancomycin AUC and trough levels during intermittent dosing of vancomycin and plateau levels during continuous infusion - Pharmacokinetic evaluation of Vancomycin and the in...
    Medical condition: In patients who receive an antibiotic therapy with vancomycin i.v. (because of an infection) blood-, urine and stool samples are taken at certain time points and data on the pharmakokinetic of vanc...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000861-36 Sponsor Protocol Number: ENS/007612 Start Date*: 2013-05-17
    Sponsor Name:Ensinger Mineral-Heilquellen GmbH
    Full Title: Double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of „Ensinger Schiller Quelle Heilwasser“ on improvement of bowel function
    Medical condition: - Functional constipation according to the ROME III criteria - The subjects have bowel movements 2 - 4 days/week
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004856 10029932 Obstipation LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002814-38 Sponsor Protocol Number: 69HCL18-0857 Start Date*: 2019-12-09
    Sponsor Name:Hospices Civils de Lyon
    Full Title: TROPHAMET, a phase I/II trial of Avelumab and METhotrexate in low-risk gestational TROPHoblastic neoplasias as first line treatment
    Medical condition: Low-risk gestational trophoblastic neoplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10018211 Gestational trophoblastic tumor NOS LLT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-000357-41 Sponsor Protocol Number: APC040 Start Date*: 2013-08-28
    Sponsor Name:The Alimentary Pharmabiotic Centre, University College Cork
    Full Title: Identification of the Microbiota Dependent Response to Rifaximin in Irritable Bowel Syndrome Patients
    Medical condition: Irritable Bowel Syndrome
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-000467-14 Sponsor Protocol Number: IEO223 Start Date*: Information not available in EudraCT
    Sponsor Name:ISTITUTO EUROPEO DI ONCOLOGIA
    Full Title: Colorectal cancer, Vitamina D and microbiota: towards new preventive strategies. A double blind Phase II randomized trial, ColoViD
    Medical condition: Colon rectal cancer stage I - III
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10001171 Adenocarcinoma of colon stage III LLT
    21.0 100000004864 10001170 Adenocarcinoma of colon stage II LLT
    21.0 100000004864 10001169 Adenocarcinoma of colon stage I LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-000297-17 Sponsor Protocol Number: 69HCL19_0153 Start Date*: 2021-01-21
    Sponsor Name:Hospices Civils de Lyon
    Full Title: IMMUNOGAST: An umbrella phase 2 trial to assess personalized targeted IMMUNOtherapy-based regimens in recurrent advanced/metastatic GASTric adenocarcinoma patients
    Medical condition: For patients with advanced/metastatic gastric adenocarcinomas in progression
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10071114 Metastatic gastric adenocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-003048-21 Sponsor Protocol Number: Uni-Köln-1667 Start Date*: 2014-03-10
    Sponsor Name:University of Cologne
    Full Title: CONTROLING INTESTINAL COLONIZATION OF HIGH-RISK PATIENTS WITH EXTENDED- SPECTRUM BETALACTAMASE PRODUCING ENTEROBACTERIACEAE (ESBL-E) – A RANDOMIZED TRIAL (CLEAR)
    Medical condition: Immunocompromised patients at high risk of bloodstream infections with colonizing bacteria.
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004864 10066481 Hematological malignancy LLT
    16.1 100000004865 10067862 Allogeneic stem cell transplantation LLT
    16.1 100000004870 10054990 Immunodeficiency secondary to organ transplantation LLT
    16.1 100000004870 10021458 Immunodeficiency secondary to transplantation chemotherapy LLT
    16.1 100000004870 10021452 Immunodeficiency secondary to chemotherapy (excl corticosteroids) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    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
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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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