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Clinical trials for Lactase

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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    6 result(s) found for: Lactase. Displaying page 1 of 1.
    EudraCT Number: 2007-004127-38 Sponsor Protocol Number: TILATT/0708 Start Date*: 2008-06-17
    Sponsor Name:AZIENDA OSPEDALIERA OSPEDALE POLICLINICO CONSORZIALE
    Full Title: USE OF ORAL TILACTASE ENZYMES IN SUBJECTS WITH LACTOSE MALABSORPTION AND INTOLERANCE. CLINICAL RELEVANCE IN A POPULATION WITH HIGH PREVALENCE OF LACTASE DEFICIENCY IN SOUTHERN ITALY.
    Medical condition: primary lactase deficiency
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10017947 Gastrointestinal disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-001368-86 Sponsor Protocol Number: SIBO_SUBSTRAT Start Date*: 2023-06-14
    Sponsor Name:Hospital Universitario de La Princesa
    Full Title: RANDOMIZED, MULTICENTRIC CLINICAL TRIAL, COMPARISON BETWEEN LACTITOL AND LACTULOSE AS SUBSTRATES BREATH TEST FOR THE DIAGNOSIS OF BACTERIAL OVERGROWTH
    Medical condition: Intestinal bacterial overgrowth
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071061 Small intestinal bacterial overgrowth LLT
    21.0 10022891 - Investigations 10065439 Hydrogen breath test PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001181-26 Sponsor Protocol Number: VPH-GXL-2013-01 Start Date*: 2015-07-16
    Sponsor Name:Venter Pharma S.L.
    Full Title: Evaluation of the impact of LacTEST on diagnostic thinking and on patient management, and of the reproducibility (Test-Retest), for the diagnosis of hypolactasia in adults and elderly patients pres...
    Medical condition: Evaluación del impacto de LacTEST en el pensamiento diagnóstico y en el manejo terapéutico del paciente, y de reproducibilidad (Test-Retest), para el diagnóstico de la hipolactasia en adultos y pob...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-005312-62 Sponsor Protocol Number: F60038 GE 401 Start Date*: 2008-03-21
    Sponsor Name:Pierre Fabre Médicament
    Full Title: Etude chez le sujet volontaire sain de l’effet de carbolevure versus placebo sur la fermentation intestinale induite par l’ingestion de lactulose.
    Medical condition: Observation chez le sujet volontaire sain de la production d’hydrogène secondaire à l’administration de lactulose avec une administration concomitante de carbolevure, association de charbon activé ...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10065439 Hydrogen breath test LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003363-35 Sponsor Protocol Number: APL2-CP-AIHA-208 Start Date*: 2018-07-05
    Sponsor Name:APELLIS PHARMACEUTCIALS, INC.
    Full Title: An open label, prospective, study to assess the safety, tolerability, efficacy and pharmacokinetics of APL-2 in patients with Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Di...
    Medical condition: Patients affected by Warm Antibody Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004851 10002045 Anaemia haemolytic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    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
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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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