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Clinical trials for Infant formula

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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    15 result(s) found for: Infant formula. Displaying page 1 of 1.
    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: 2009-018218-21 Sponsor Protocol Number: NIC-03 Start Date*: 2010-06-02
    Sponsor Name:Menarini Ricerche S.p.A.
    Full Title: Double-blind, randomised, placebo-controlled, parallel group study to evaluate the efficacy and safety of oral administration of Nepadutant in infant colic
    Medical condition: Infant Colic
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004856 10021732 Infant colic LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed)
    Trial results: View results
    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: 2021-000063-79 Sponsor Protocol Number: MN42989 Start Date*: 2021-10-22
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS OF LACTATING WOMEN WITH CIS OR MS RECEIVING OCRELIZUMAB – THE SOPRANINO STUDY
    Medical condition: Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10071068 Clinically isolated syndrome PT
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (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: 2006-000359-16 Sponsor Protocol Number: VD-3 Start Date*: 2007-04-16
    Sponsor Name:Ove Bäck, Dept Dermatology, University Hospital, Lund, Sweden
    Full Title: Vitamin D and atopic allergy
    Medical condition: Cumulative incidence of atopic allergy specified as atopic dermatitis, allergic asthma, and allergic rhinitis. Since IMP is a food supplement to protect from rickets we are looking at clinical sym...
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-001346-17 Sponsor Protocol Number: ALN-GO1-005 Start Date*: 2020-02-20
    Sponsor Name:Alnylam Pharmaceuticals, Inc.
    Full Title: ILLUMINATE-C: A Single Arm Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1 (PH1)
    Medical condition: Primary Hyperoxaluria Type 1 (PH1)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10038359 - Renal and urinary disorders 10020703 Hyperoxaluria PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Completed) GB (GB - no longer in EU/EEA) BE (Trial now transitioned) NL (Ongoing) Outside EU/EEA IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002663-10 Sponsor Protocol Number: 232SM203 Start Date*: 2020-03-27
    Sponsor Name:Biogen Idec Research Limited
    Full Title: Escalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy
    Medical condition: Muscular Atrophy, Spinal
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10041582 Spinal muscular atrophy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: LV (Completed) IE (Completed) HU (Completed) PL (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA) DE (Completed) FR (Completed) GR (Completed) IT (Completed) NL (Ongoing)
    Trial results: View results
    EudraCT Number: 2020-005991-36 Sponsor Protocol Number: 156-12-204 Start Date*: 2022-10-07
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 12 weeks of Age with Autosomal Recessive Polycystic Kidne...
    Medical condition: Autosomal Recessive Polycystic Kidney Disease (ARPKD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036047 Polycystic kidney, autosomal recessive LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005992-10 Sponsor Protocol Number: 156-201-00307 Start Date*: Information not available in EudraCT
    Sponsor Name:Otsuka Pharmaceutical Development & Commercialization, Inc.
    Full Title: A Phase 3b Multicenter Open-label Trial of the Safety, Tolerability, and Efficacy of Tolvaptan in Infants and Children 28 days to less than 18 years of Age with Autosomal Recessive Polycystic Kidne...
    Medical condition: Autosomal Recessive Polycystic Kidney Disease (ARPKD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10036047 Polycystic kidney, autosomal recessive LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) ES (Ongoing) BE (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004708-32 Sponsor Protocol Number: 232SM302 Start Date*: Information not available in EudraCT
    Sponsor Name:Biogen Idec Research Limited
    Full Title: A Long-Term Extension Study of Nusinersen (BIIB058) Administered at Higher Doses in Participants With Spinal Muscular Atrophy Who Previously Participated in an Investigational Study With Nusinersen
    Medical condition: Muscular Atrophy, Spinal
    Disease: Version SOC Term Classification Code Term Level
    20.1 10010331 - Congenital, familial and genetic disorders 10041582 Spinal muscular atrophy PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: EE (Completed) ES (Ongoing) HU (Prematurely Ended) DE (Trial now transitioned) PL (Completed) IT (Trial now transitioned) NL (Ongoing) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-015884-15 Sponsor Protocol Number: IMPAACT-P1066 Start Date*: 2011-06-30
    Sponsor Name:The National Institute of Allergy and Infectious Diseases (NIAID) and The Eunice Kennedy Shriver NICHD
    Full Title: A Phase I/II, Multicenter, Open-Label, Non comparative Study of the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Group to Evaluate the Safety, Tolerability, Pharmac...
    Medical condition: HIV
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10020161 HIV infection PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-002988-16 Sponsor Protocol Number: MINT-2014-01 Start Date*: 2015-07-01
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: The Use of Milrinone in Neonates with Persistent Pulmonary Hypertension of the Newborn: A Randomised Controlled Trial Pilot Study (MINT 1)
    Medical condition: Persistent Pulmonary Hypertension of the Newborn
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004850 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-003195-19 Sponsor Protocol Number: ICORG06-36 Start Date*: 2007-08-16
    Sponsor Name:ICORG
    Full Title: A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (> 4 cm) - IIIA Non- Small Cell Lung Cancer (NSCLC)
    Medical condition: Completely Resected Stage IB (≥4 cm)-IIIA Non-Small Cell Lung Cancer (NSCLC).
    Disease: Version SOC Term Classification Code Term Level
    17.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-003949-32 Sponsor Protocol Number: A6281287 Start Date*: 2007-12-21
    Sponsor Name:Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
    Full Title: A two-year multi-centre, randomized two arm study of Genotropin treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN)
    Medical condition: Short Stature children born small for Gestational Age (SGA)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10041093 Small for gestational age LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) BE (Completed) ES (Completed) AT (Completed) GB (Completed) FR (Completed) IT (Completed) DE (Completed) NL (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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