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Clinical trials for Enterocolitis

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 ).  
     
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    80 result(s) found for: Enterocolitis. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2019-002548-26 Sponsor Protocol Number: 0139 Start Date*: 2020-12-16
    Sponsor Name:Royal College of Surgeons in Irlenad
    Full Title: Can Pentoxifylline improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing enterocolitis? A pragmatic, randomised, placebo controlled trial
    Medical condition: Late onset sepsis & necrotising enterocolitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053598 Late onset neonatal sepsis LLT
    20.1 100000004856 10028884 Necrotising enterocolitis LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-000754-22 Sponsor Protocol Number: IBP-9414-020 Start Date*: 2019-10-14
    Sponsor Name:Infant Bacterial Therapeutics AB (IBT)
    Full Title: A randomized, double blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of IBP-9414 in premature infants 500-1500g birth weight in the prevention of necrotizing ent...
    Medical condition: Necrotizing Enterocolitis (NEC)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10052818 Necrotizing enterocolitis neonatal LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) HU (Completed) ES (Ongoing) BG (Completed) PL (Completed) RO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000453-41 Sponsor Protocol Number: BMBF-Fz01KG1602 Start Date*: 2018-05-29
    Sponsor Name:University Hospital Tuebingen
    Full Title: Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants – a randomized controlled parallel group multicenter trial for safety...
    Medical condition: Extremely low gestational age neonates (ELGANs), i.e. those who are born at <28 weeks gestation and who uniformly suffer from intermittent hypoxemic episodes.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    20.1 10015919 - Eye disorders 10038933 Retinopathy of prematurity PT
    20.1 10017947 - Gastrointestinal disorders 10055667 Necrotising enterocolitis neonatal PT
    20.1 10018065 - General disorders and administration site conditions 10011912 Death neonatal PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10071101 Primary apnoea of premature newborns LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-003445-17 Sponsor Protocol Number: BBG001 Start Date*: 2009-05-12
    Sponsor Name:Queen Mary, University of London
    Full Title: The probiotic Bifidobacterium breve strain BBG-01 admistered early to preterm infants to prevent infection, necrotising enterocolitis and death.
    Medical condition: Necrotising enterocolitis in the preterm baby Late-onset (>72h of age) blood stream infection in the preterm baby Death of preterm babies before discharge from hospital
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-003596-17 Sponsor Protocol Number: CMAS825D12201 Start Date*: 2021-03-09
    Sponsor Name:Novartis Pharma AG
    Full Title: A three-period multicenter study, with a randomized withdrawal, double-blinded, placebo-controlled design in Period 2 to evaluate the clinical efficacy, safety and tolerability of MAS825 in NLRC4-G...
    Medical condition: NLRC4-GOF, AIFEC (autoinflammation with infantile enterocolitis)
    Disease: Version SOC Term Classification Code Term Level
    23.1 10010331 - Congenital, familial and genetic disorders 10084306 Autoinflammation with infantile enterocolitis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003177-14 Sponsor Protocol Number: IBUPAR-Trial Start Date*: 2016-04-06
    Sponsor Name:
    Full Title: Paracetamol versus ibuprofen in preterm infants with a hemodynamically significant patent ductus arteriosus: a randomized clinical trial.
    Medical condition: Persistent ductus arteriosus haemodynamically significant
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-001324-31 Sponsor Protocol Number: 16/2008/O/Sper Start Date*: 2008-07-09
    Sponsor Name:AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    Full Title: Efficacy and security of oral supplementation with a probiotic (Lactobacillus reuteri) in newborns with birth weight < 1500 g: effects on necrotising enterocolitis (NEC) and gut colonization with g...
    Medical condition: necrotising enterocolitis (NEC
    Disease: Version SOC Term Classification Code Term Level
    9.1 10014878 Enteritis necroticans LLT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-004228-70 Sponsor Protocol Number: IBP-9414-010 Start Date*: 2015-12-28
    Sponsor Name:Infant Bacterial Therapeutics AB
    Full Title: A randomized, double blind, parallel-group, dose escalation placebo-controlled multicentre study to investigate the safety and tolerability of IBP-9414 administered in preterm infants
    Medical condition: Prevention of necrotizing enterocolitis in preterm infants with birth weight less than or equal to 1,500 grams
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-003202-77 Sponsor Protocol Number: NEOKOFF22 Start Date*: 2023-04-04
    Sponsor Name:
    Full Title: The effect of additional pre-extubational loading dose of caffeine-citrate
    Medical condition: Extubation failure and bronchopulmonary dysplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10002973 Apnea neonatal LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10071132 Primary apnea of premature newborns LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077322 Infantile apnea LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077325 Infantile obstructive apnea LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077328 Infantile central apnea LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028975 Neonatal respiratory failure PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    20.0 100000004868 10076729 Very preterm infant LLT
    23.1 100000004868 10084217 Extremely preterm (less than 28 weeks) LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004890-29 Sponsor Protocol Number: FIT-PIV Start Date*: 2023-03-09
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
    Medical condition: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10025479 Malabsorption syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) SE (Trial now transitioned) NL (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-005987-15 Sponsor Protocol Number: The Triple P study Start Date*: 2009-10-22
    Sponsor Name:AMC Amsterdam
    Full Title: Preventing preterm birth: Costs and effects of screening of healthy women with a singleton pregnancy for a short cervical length.
    Medical condition: Preterm birth with healthy singleton pregnancies
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036600 Premature labour LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-005717-36 Sponsor Protocol Number: 1645-CI-057 Start Date*: 2012-06-14
    Sponsor Name:Instituto de Investigación Sanitaria La Fe
    Full Title: Extremely low gestational age neonates randomly an assigned to be blindly resuscitated with 21% vs. 60% oxygen: influence upon mortality and chronic conditions in the neonatal period.
    Medical condition: Preterm infants aged 30 weeks or less, who need resuscitation / stabilization maneuvers with positive pressure ventilation immediately after birth
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-000174-66 Sponsor Protocol Number: APOSTELIV Start Date*: 2012-02-07
    Sponsor Name:Academic Medical Centre
    Full Title: Assessment of Perinatal Outcome by uSe of Tocolysis in Early Labour (APOSTEL IV); Nifedipine versus placebo in the treatment of preterm premature rupture of membranes
    Medical condition: Premature preterm rupture of membranes
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036600 Premature labour PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-002170-34 Sponsor Protocol Number: 2004-002170-34 Start Date*: 2006-03-29
    Sponsor Name:Cambridge University Hospital (Addenbrookes Hospital)
    Full Title: "Ensayo clínico controlado randomizado sobre el tratamiento precoz con insulina en recién nacidos de muy bajo peso"
    Medical condition: Very low birth weight infants requiring intensive care have relative insulin deficiency often leading to hyperglycaemia during the first week of life. There is increasing evidence that the early po...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-000735-80 Sponsor Protocol Number: 2010-382 Start Date*: 2011-05-16
    Sponsor Name:Lene Drasbek Huusom
    Full Title: Administration of antenatal magnesium sulphate for prevention of cerebral palsy in preterm infants (MASP-STUDY)
    Medical condition: Moderate to severe cerebral palsy
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-000302-31 Sponsor Protocol Number: 04/S0101/65 Start Date*: 2005-04-25
    Sponsor Name:NHS Lanarkshire, Primary Care Operating Division
    Full Title: TOLERANCE OF MILK FEEDS IN PRETERM, VERY LOW BIRTH WEIGHT BABIES: THE USE OF GLYCERINE SUPPOSITORIES
    Medical condition: The problem is inability to sustain enteral feeding in very low birth weight babies due to feed intolerance. The necessity for parenteral feeding creates risk of sepsis, cholestasis,increased oxyge...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002925-29 Sponsor Protocol Number: 200605 Start Date*: 2005-09-20
    Sponsor Name:University Childrens Hospital
    Full Title: Irinotecan singele drug treatment for children with refractory or relapsed hepatoblastoma
    Medical condition: Refractory or recurrent hepatoblastoma
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2009-010163-16 Sponsor Protocol Number: 08/0285 Start Date*: 2009-06-05
    Sponsor Name:University College London
    Full Title: Bile salt manipulation as a novel treatment for Crohn’s disease: a single centre open label pilot study of atorvastatin and colesevalam in patients with active ileal Crohn’s disease
    Medical condition: Active Crohn's disease affecting the ileum
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011406 Crohn's ileitis LLT
    9.1 10058815 Crohn's disease acute episode LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-003002-32 Sponsor Protocol Number: 2819-MA-1003 Start Date*: 2015-05-05
    Sponsor Name:Astellas Pharma Europe Ltd.
    Full Title: Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI)
    Medical condition: Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10022661 Intestinal infection due to clostridium difficile LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) DE (Completed) AT (Completed) GR (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-004619-31 Sponsor Protocol Number: 2819-MA-1002 Start Date*: 2014-09-01
    Sponsor Name:Astellas Pharma Europe Ltd.
    Full Title: A phase IIIb/IV randomized, controlled, open label, parallel group study to compare the efficacy of vancomycin therapy to extended duration fidaxomicin therapy in the sustained clinical cure of Clo...
    Medical condition: Clostridium Difficile Infection (CDI) also known as C. difficile-associated diarrhoea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10022661 Intestinal infection due to clostridium difficile LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed) GB (Completed) CZ (Completed) DK (Completed) DE (Completed) IT (Completed) GR (Completed) SI (Completed) HU (Completed) IE (Completed) AT (Completed) BE (Completed) PT (Completed) HR (Completed)
    Trial results: View results
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