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Clinical trials for Breast 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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    37 result(s) found for: Breast milk. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2021-002247-30 Sponsor Protocol Number: RC31/21/0217 Start Date*: 2021-09-24
    Sponsor Name:CHU TOULOUSE
    Full Title: Evaluation of Amoxicillin diffusion in breast milk according to a population pharmacokinetic approach.
    Medical condition: Breastfeeding
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-004523-21 Sponsor Protocol Number: V1605-201 Start Date*: 2020-09-03
    Sponsor Name:DBV Technologies S.A.
    Full Title: A Phase 2 Study to Evaluate the Sensitivity and Specificity of DBV1605, a Ready to Use Atopy Patch Test for the Diagnosis of Non-Immunoglobulin E Mediated Cow’s Milk Allergy in Children.
    Medical condition: Non-Immunoglobulin E Mediated Cow’s Milk Allergy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004870 10011240 Cow's milk allergy LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-004249-29 Sponsor Protocol Number: DALMATION/7212 Start Date*: 2015-10-30
    Sponsor Name:The Newcastle Upon Tyne Hospitals NHS Foundation Trust
    Full Title: An Open Label, Non-Randomised, Phase II study to Determine if Dabigatran and its Metabolites are Detectable in Breast Milk Following Oral Administration to Non-Breastfeeding Mothers
    Medical condition: Future use for VTE prophylaxis.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-003852-19 Sponsor Protocol Number: DOAC Start Date*: 2019-03-29
    Sponsor Name:King's College London [...]
    1. King's College London
    2. King's College Hospital NHS Foundation Trust
    Full Title: An Open Label, Non-Randomised, Phase IV Clinical Trial to Determine the Transfer of Apixaban and Rivaroxaban in Breast Milk Following Oral Administration
    Medical condition: healthy volunteers (Venous Thromboembolism)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10049909 Venous thromboembolism prophylaxis LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    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: 2014-001538-28 Sponsor Protocol Number: P130930 Start Date*: Information not available in EudraCT
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004848 10070264 Measles virus test positive LLT
    Population Age: Newborns, Under 18, Adults Gender: Female
    Trial protocol: FR (Ongoing) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000893-27 Sponsor Protocol Number: SJ2021016 Start Date*: 2021-04-27
    Sponsor Name:AZ Sint-Jan Brugge-Oostende AV
    Full Title: COVID-19: study to detect transfer of SARS-Cov-2 antibodies in breastmilk
    Medical condition: pregnancy lactating mothers
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-004509-29 Sponsor Protocol Number: 2012-776 Start Date*: 2015-11-03
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Antidepressant treatments during pregnancy and lactation: prediction of drug exposure through breastfeeding and evaluation of drug effect on the neonatal adaptation and the development of the youn...
    Medical condition: depression
    Disease: Version SOC Term Classification Code Term Level
    18.0 10037175 - Psychiatric disorders 10012378 Depression PT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    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: 2015-005751-27 Sponsor Protocol Number: X213220 Start Date*: 2016-05-18
    Sponsor Name:XOMA (US) LLC
    Full Title: A Multi-Center, Open-Label, Randomized, Single-Dose, Controlled Trial of Intravenously Administered XOMA 213 in Suppression of Lactation after Delivery in Postpartum Women
    Medical condition: Suppression of Lactation after Delivery in Postpartum Women
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005194-77 Sponsor Protocol Number: Matimmunestudyversion2 Start Date*: 2021-10-26
    Sponsor Name:University of Antwerp
    Full Title: The optimal timing of vaccination in pregnancy: a multi-dimensional mechanistic approach to measure immune responses in pregnant women
    Medical condition: humoral and cellular immune responses to pertussis vaccine during pregnancy
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: BE (Trial now transitioned)
    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: 2010-019372-72 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 (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-002544-40 Sponsor Protocol Number: 5866 Start Date*: 2014-10-29
    Sponsor Name:Hôpitaux Universitaires de Strasbourg
    Full Title: THE TREATMENT OF HYPERTENSION ASSOCIATED WITH SEVERE PREECLAMPSIA. A RANDOMIZED CONTROLLED TRIAL OF URAPIDIL VERSUS NICARDIPINE. The URANIC trial.
    Medical condition: Hypertension associated with severe pre eclampsia
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-003764-45 Sponsor Protocol Number: UOL0727 Start Date*: 2020-02-14
    Sponsor Name:University of Leicester
    Full Title: Multicentre, open-label, randomised controlled trial of early surfactant therapy versus expectant management in late preterm and early term infants with respiratory distress.
    Medical condition: Respiratory distress in neonates born at 34 to 38+6 weeks of gestation
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2007-007003-33 Sponsor Protocol Number: ALID01803 Start Date*: 2010-09-16
    Sponsor Name:Genzyme Europe BV
    Full Title: A Multicenter, Multinational, Open-Label Study of the Effects of Aldurazyme(laronidase) Treatment on Lactation in Women with Mucopolysaccharidosis I (MPS I) and Their Breastfed Infants
    Medical condition: mucocopolysaccharidoses I
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056886 LLT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Ongoing)
    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: 2005-002325-31 Sponsor Protocol Number: 11.105 Start Date*: 2005-11-04
    Sponsor Name:Taunton & Somerset NHS Trust
    Full Title: Two parallel trials to compare the effectiveness, and potential adverse side-effects, of four routinely used topical therapies to prolong breastfeeding, by either (1) preventing or (2) treating nip...
    Medical condition: Nipple pain in breastfeeding women
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-002012-27 Sponsor Protocol Number: KEDOB Start Date*: 2013-10-30
    Sponsor Name:LANDSTINGET I ÖSTERGÖTLAND
    Full Title: Ketamine dose finding study in pediatric burn wound care
    Medical condition: Pediatric burn patients who need rectal sedation during wound care
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-003466-39 Sponsor Protocol Number: Protocol_MAMA_studie_22/05/2018 Start Date*: Information not available in EudraCT
    Sponsor Name:University of Antwerp
    Full Title: Pertussis immunization during pregnancy: assessment of the role of maternal antibodies on immune responses in term and preterm infants (the MAMA study)
    Medical condition: The effect of pertussis vaccination during pregnancy on the immune response after infant and childhood vaccinations in term and preterm infants.
    Disease:
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    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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