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Clinical trials for Human Milk

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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    15 result(s) found for: Human Milk. Displaying page 1 of 1.
    EudraCT Number: 2006-001910-33 Sponsor Protocol Number: AGAL02603 Start Date*: 2007-12-05
    Sponsor Name:Genzyme Europe BV
    Full Title: A Multicenter, Multinational Study of the Effects of Fabrazyme® (agalsidase beta) Treatment on Lactation and Infants
    Medical condition: Fabry disease
    Disease: Version SOC Term Classification Code Term Level
    9.1 10016016 Fabry's disease PT
    Population Age: In utero, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) AT (Ongoing)
    Trial results: View results
    EudraCT Number: 2007-002434-10 Sponsor Protocol Number: BVT.BSSL-021 Start Date*: 2007-10-17
    Sponsor Name:Biovitrum AB (publ.)
    Full Title: A prospective, randomised, double-blind crossover study comparing 0.15 g/L rhBSSL added to pasteurized breast milk versus placebo during one week of treatment in preterm infants born before week 32...
    Medical condition: Enzyme replacement therapy in pre-term infants. Reduced fat uptake capabilities due to prematurity of pre-term infants
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-019372-72 Sponsor Protocol Number: MV22970 Start Date*: 2010-04-16
    Sponsor Name:Pharmahungary Group
    Full Title: An Observational Study on the Pharmacokinetics of Oseltamivir in the Treatment of Influenza during Lactation.
    Medical condition: Lactating women who present with clinical symptoms indicative of influenza will be recruited to receive immediate treatment with oseltamivir at a standard dose of 75 mg twice daily. These subjects ...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10022000 Influenza LLT
    Population Age: Adults Gender: Female
    Trial protocol: HU (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-003197-57 Sponsor Protocol Number: A0081181 Start Date*: 2012-11-09
    Sponsor Name:Pfizer Worldwide Research and Development
    Full Title: A MULTIPLE DOSE PHARMACOKINETIC OPEN-LABEL STUDY OF PREGABALIN (LYRICA) IN HEALTHY LACTATING WOMEN
    Medical condition: neuropathic pain associated with diabetic peripheral neuropathy postherpetic neuralgia neuropathic pain related to spinal cord injury (US), fibromyalgia (US, JP) treatment of central and periphe...
    Disease: Version SOC Term Classification Code Term Level
    15.1 10029205 - Nervous system disorders 10028005 Motor peripheral neuropathy LLT
    15.1 10029205 - Nervous system disorders 10054095 Neuropathic pain LLT
    15.1 10029205 - Nervous system disorders 10036376 Post herpetic neuralgia PT
    15.1 10029205 - Nervous system disorders 10067547 Diabetic peripheral neuropathic pain LLT
    15.1 10022117 - Injury, poisoning and procedural complications 10041552 Spinal cord injury PT
    15.1 10037175 - Psychiatric disorders 10018075 Generalised anxiety disorder PT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023909-35 Sponsor Protocol Number: BVT.BSSL-030 Start Date*: 2011-06-24
    Sponsor Name:Swedish Orphan Biovitrum AB (publ)
    Full Title: A Prospective, Randomized, Double-Blind, Phase 3 Study Comparing rhBSSL and Placebo Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants Born Before Wee...
    Medical condition: Prevention of growth retardation due to lack of bile salt-stimulated lipase in enteral nutrition
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036590 Premature baby PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) BE (Prematurely Ended) SE (Prematurely Ended) DE (Prematurely Ended) HU (Completed) FR (Ongoing) CZ (Completed) PL (Prematurely Ended) ES (Prematurely Ended) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-003140-56 Sponsor Protocol Number: D200 Probørn Start Date*: 2006-02-10
    Sponsor Name:Department of Human Nutrition, The Royal Veterinary and Agricultural University
    Full Title: Probiotics to infants with atopic dermatitis; an investigation of the effect on eczema, immune system and intestinal microflora, inflammation and permeability. DK-titel Probiotiske bakterier til ...
    Medical condition: Infants participating in the clinical trial are suffering from atopic dermatitis
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-001736-95 Sponsor Protocol Number: ACCORD-2-001,Sub002,003,006 Start Date*: 2020-04-28
    Sponsor Name:University Hospital Southampton NHS Foundation Trust
    Full Title: ACCORD 2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID 19 in Hospitalised Patients
    Medical condition: COVID 19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-004392-41 Sponsor Protocol Number: MK-1439A-054 Start Date*: 2016-11-21
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Study of the Comparative Bioavailability of Two Investigational Pediatric Oral Granule Formulations of Lamivudine and Tenofovir Compared to the Adult Marketed Formulations. Other PIP decision ...
    Medical condition: HIV-1 infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-004740-36 Sponsor Protocol Number: MINT (CRO1834) Start Date*: 2011-08-04
    Sponsor Name:Imperial College, London
    Full Title: Melatonin As A Novel Neuroprotectant In Preterm Infants−Trial Study
    Medical condition: Brain injury from prematurity
    Disease: Version SOC Term Classification Code Term Level
    14.0 10036585 - Pregnancy, puerperium and perinatal conditions 10013384 Disorders relating to short gestation and unspecified low birthweight LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-005256-33 Sponsor Protocol Number: 1182.107 Start Date*: 2007-09-14
    Sponsor Name:Boehringer Ingelheim España, S.A.
    Full Title: Ensayo clínico multicéntrico, aleatorizado y abierto para evaluar tres dosis de Tipranavir potenciado con dosis bajas de ritonavir (500mg/200mg una vez al día, 250mg/100 mg dos veces al día y 500 m...
    Medical condition: Los pacientes de este estudio deben ser varones y mujeres con edades comprendidas entre los 18 y los 65 años de edad infectados por VIH-1 y no tratados anteriormente con antirretrovirales.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10020192 HIV-1 LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-011186-88 Sponsor Protocol Number: ABB-09-001 Start Date*: 2009-09-08
    Sponsor Name:FONDAZIONE CENTRO EMOFILIA E TROMBOSI ANGELO BIANCHI BONOMI
    Full Title: Desarrollo de inhibidores en pacientes no tratados previamente (PUP) o en pacientes mínimamente tratados con componentes sanguíneos (MBCTP) al ser expuestos a concentrados de derivados plasmáticos ...
    Medical condition: El estudio es un ensayo clínico abierto, aleatorizado, controlado, prospectivo, multicéntrico, internacional e independiente sobre la frecuencia de formación de inhibidores en pacientes no tratados...
    Disease: Version SOC Term Classification Code Term Level
    9 10018937 Haemophilia A LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male
    Trial protocol: ES (Prematurely Ended) IT (Completed) PT (Completed) FR (Ongoing) DE (Restarted) AT (Prematurely Ended) BE (Ongoing) GB (GB - no longer in EU/EEA) SK (Ongoing) CZ (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-002423-33 Sponsor Protocol Number: BVT.BSSL-020 Start Date*: 2007-10-30
    Sponsor Name:BIOVITRUM AB
    Full Title: A prospective, randomised, double-blind crossover study comparing 0.15 g/L rhBSSL added to infant formula versus placebo during one week of treatment in preterm infants born before week 32 of gesta...
    Medical condition: Enzyme replacement therapy in pre-term infants. Reduced fad uptake capabilities due to prematurity of pre-term infants
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013317 Lipid metabolism disorders HLGT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002624-28 Sponsor Protocol Number: FIT-EU-04 Start Date*: 2015-09-24
    Sponsor Name:Nutrinia Ltd.
    Full Title: A Multi-center, Double-blind, Randomized Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Gastrointestinal Maturation in Preterm Infants.
    Medical condition: Gastrointestinal Maturation in Preterm Infants.
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) BE (Completed) NL (Prematurely Ended) GB (Prematurely Ended) HU (Prematurely Ended) DE (Prematurely Ended) BG (Prematurely Ended) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    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 (Ongoing) ES (Ongoing) SE (Ongoing) NL (Ongoing) AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-004195-42 Sponsor Protocol Number: FIT-05 Start Date*: Information not available in EudraCT
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest
    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 (Ongoing) SE (Ongoing) ES (Ongoing) NL (Ongoing) AT (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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