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Clinical trials for Microbiota

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.
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    1 result(s) found for: Microbiota. Displaying page 1 of 10.
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    EudraCT Number: 2020-000311-71 Sponsor Protocol Number: APHP180572 Start Date*: 2022-02-11
    Sponsor Name:AP-HP/DRCD
    Full Title: Pilot study of a new technique of Oral Fecal Transplantation using frozen stool capsules for the maintenance treatment of UC with pediatric onset
    Medical condition: ulcerative colitis
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-001197-18 Sponsor Protocol Number: NOR-BGT-14-10665 Start Date*: 2015-05-20
    Sponsor Name:Biogen Idec Norway
    Full Title: The effect of Tecfidera® (Dimethyl Fumarate) on the gut microbiota as a causal factor for GI associated adverse events.
    Medical condition: multiple sclerosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: View results
    EudraCT Number: 2019-003433-41 Sponsor Protocol Number: APHP180583 Start Date*: 2023-08-30
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: A prospective, multi-center, double blind randomized trial of fecal microbiota transplantation (FMT) delivered by capsule versus placebo in severe irritable bowel syndrome (IBS) - ICEBOAT (Ibs Caps...
    Medical condition: Adult patients with severe Irritable Bowel Syndrome (IBS) diagnosed
    Disease: Version SOC Term Classification Code Term Level
    20.1 10017947 - Gastrointestinal disorders 10023003 Irritable bowel syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000673-24 Sponsor Protocol Number: PHRC_N_2018_BAY Start Date*: 2021-04-15
    Sponsor Name:CHU de Clermont-Ferrand
    Full Title: Faecal microbiota transplantation for prevention of graft-versus-host sisease after allogeneic stem cell transplantation for haematological malignancies
    Medical condition: Patient who underwent Allogeneic hematopoietic stem cell transplantation (allo-HSCT) for various haematological malignancies. Faecal microbiota transplantation (FMT) will be assessed to prevent al...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-003704-31 Sponsor Protocol Number: ARG-16 Start Date*: 2019-05-17
    Sponsor Name:Uppsala University
    Full Title: Impact on the intestinal microbiota during antibiotic treatment
    Medical condition: Impact on the intestinal microbiota during antibiotic treatment
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    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: 2015-000467-14 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: 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: 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 (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-006814-35 Sponsor Protocol Number: MoodBugs_Rifaximin Start Date*: 2022-09-27
    Sponsor Name:KU Leuven
    Full Title: A randomized, triple-blind, placebo-controlled study on the effect of rifaximin on psychobiological functions in healthy men
    Medical condition: Experimental study with healthy participants recruited from the general population; no vulnerable individuals or clinical groups will be involved. Our objective is to test whether rifaximin adminis...
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: BE (Trial now transitioned)
    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: 2017-004248-39 Sponsor Protocol Number: PPI-microbiome Start Date*: 2018-01-04
    Sponsor Name:TARGID, KU Leuven
    Full Title: Effect of Proton Pump Inhibitors on the duodenal microbiome in healthy volunteers
    Medical condition: We will assess the effect of Proton Pump Inhibitors (PPI) on the duodenal, oral and fecal microbiota composition in healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    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: 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 (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003654-33 Sponsor Protocol Number: FLORAL-Sb185 Start Date*: 2016-12-14
    Sponsor Name:BIOCODEX
    Full Title: Effects of the probiotic Saccharomyces boulardii CNCM I-745 and the antibiotic Amoxicillin on the gut microbiota of healthy volunteers An open-label, randomized, parallel groups, monocentric study
    Medical condition: Healthy volunteers
    Disease: Version SOC Term Classification Code Term Level
    19.1 10017947 - Gastrointestinal disorders 10017947 Gastrointestinal disorders SOC
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-003835-28 Sponsor Protocol Number: APHP210089 Start Date*: 2022-02-17
    Sponsor Name:ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS
    Full Title: Prevention of C. difficile infections with oral vancomycin in patients treated for allogeneic hematopoietic stem cell transplantation, a double-blind, randomized, placebo-controlled trial ” VANCALLO
    Medical condition: Patients hospitalized for an allogeneic hematopoietic stem cell transplant
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004865 10059044 Allogeneic peripheral hematopoietic stem cell transplant LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    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: 2016-003655-29 Sponsor Protocol Number: T216/2016 Start Date*: 2017-02-23
    Sponsor Name:Turku University Hospital
    Full Title: Acute appendicitis and microbiota- etiology and effects of the antimicrobial treatment
    Medical condition: Acute appendicitis
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10000677 Acute appendicitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004180-13 Sponsor Protocol Number: OCARINA Start Date*: 2021-10-18
    Sponsor Name:KU Leuven
    Full Title: The effect of obeticholic acid on gut microbiota, gastric motility, accommodation, gastrointestinal peptide in healthy volunteers
    Medical condition: The study will focus on the underlying mechanisms of gastrointestinal motility and gut microbiota in healthy subjects.
    Disease: Version SOC Term Classification Code Term Level
    21.0 10022891 - Investigations 10017782 Gastric emptying study PT
    20.1 100000004856 10061247 Intestinal functional disorder LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004208-37 Sponsor Protocol Number: S63190 Start Date*: 2020-08-03
    Sponsor Name:UZ Leuven
    Full Title: Drug repurposing - Statins as microbiota modulating agents in ulcerative colitis
    Medical condition: There are two population groups, 20 healthy volunteers and at least 165 individuals diagnosed with IBD. Either with remission to mild/moderate active ulcerative colitis or remission to mild Crohn's...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (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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