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Clinical trials for Lactulose

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   44336   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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    19 result(s) found for: Lactulose. Displaying page 1 of 1.
    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: 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: 2013-002900-15 Sponsor Protocol Number: Transidose-GE_01/2013 Start Date*: 2014-04-28
    Sponsor Name:Salsarulo Pharma
    Full Title: Clinical trial to evaluate the efficacy and safety of oral Transidose in patients suffering from constipation.
    Medical condition: Constipation
    Disease: Version SOC Term Classification Code Term Level
    18.1 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2012-001263-73 Sponsor Protocol Number: 30-01-2012_1 Start Date*: 2012-05-25
    Sponsor Name:UZ Leuven
    Full Title: Involvement of corticotrophin-releasing hormone (CRH) and mucosal mast cells in stress-induced changes in intestinal permeability in healthy volunteers.
    Medical condition: Stress-induced intestinal hyperpermeability
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10001039 Acute reaction to stress LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-003722-33 Sponsor Protocol Number: REROS/001/17 Start Date*: 2018-03-02
    Sponsor Name:ALFASIGMA S.P.A.
    Full Title: Safety and Efficacy of Rifaximin Delayed Release 400 mg Tablets in Patients with Moderate-to-Severe Papulopustular Rosacea and Positive Lactulose Breath Test. A Multicenter Double-Blind, Placebo-Co...
    Medical condition: Moderate-to-Severe Papulopustular Rosacea and Positive Lactulose Breath Test
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10076537 Papulopustular rosacea PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2018-002359-14 Sponsor Protocol Number: Lact-004-CP4 Start Date*: 2018-10-17
    Sponsor Name:Fresenius Kabi Deutschland GmbH
    Full Title: Blood Glucose Response After Oral Intake of Lactulose (Laevolac®) in Mildly Constipated Patients with Diabetes Mellitus Type 2
    Medical condition: Symptomatic treatment of constipation
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10010774 Constipation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-004323-37 Sponsor Protocol Number: PEARL-trial Start Date*: 2019-06-06
    Sponsor Name:Academic Medical Centre
    Full Title: Prevention of hepatic Encephalopathy by Administration of Rifaximin and Lactulose in patients with liver cirrhosis undergoing placement of a transjugular intrahepatic portosystemic shunt: a multi-c...
    Medical condition: post-TIPS Hepatic Encephalopathy (HE)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10019660 Hepatic encephalopathy PT
    20.0 10029205 - Nervous system disorders 10076204 Minimal hepatic encephalopathy PT
    20.1 10042613 - Surgical and medical procedures 10066599 Hepatic encephalopathy prophylaxis PT
    21.1 10042613 - Surgical and medical procedures 10068826 Transjugular intrahepatic portosystemic shunt LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-002116-10 Sponsor Protocol Number: i3.1_IBS+SIBO Start Date*: 2019-09-27
    Sponsor Name:AB-Biotics S.A.
    Full Title: Interventional post-marketing study to evaluate i3.1 efficacy on SIBO (Small Intestinal Bacterial Overgrowth)reduction in IBS (Irritable bowel syndrom) patients
    Medical condition: Irritable Bowel Syndrome (IBS) + Small Intestinal Bacterial Overgrowth (SIBO)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003651-30 Sponsor Protocol Number: UCAB-CT-02 Start Date*: 2016-12-01
    Sponsor Name:Umecrine Cognition AB
    Full Title: Safety, tolerability and pharmacokinetics (PKs) of multiple oral doses of GR3027 in healthy male volunteers and single and multiple doses in patients with cirrhosis. Preliminary efficacy in cirrhot...
    Medical condition: Hepatic encephalopathy (HE)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DK (Completed) FI (Completed) PL (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2017-002811-33 Sponsor Protocol Number: LAINCO1107 Start Date*: 2017-12-11
    Sponsor Name:LAINCO S.A
    Full Title: Unilateral, open and randomized phase IV study of 2 groups to assess the degree of comfort with simple Emuliquen® in patients undergoing proctological surgery
    Medical condition: Surgery proctological
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000016398 10042759 Symptoms involving digestive system LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-003817-32 Sponsor Protocol Number: LOLA-Merz:WMDHP39937 Start Date*: 2013-01-08
    Sponsor Name:Imperial College London
    Full Title: Brain muscle axis during treatment of hepatic encephalopathy with L-ornithine L-aspartate
    Medical condition: Hepatic Encephalopathy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029205 - Nervous system disorders 10019660 Hepatic encephalopathy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-004934-42 Sponsor Protocol Number: PM L 0161 Start Date*: 2006-04-13
    Sponsor Name:SANOFI-AVENTIS OTC
    Full Title: Efficacy evaluation of Enterogermina, 2 billion Bacillus clausii spores, on eradication of small intestinal bacterial overgrowth a randomised, parallel-group, open study
    Medical condition: irritable bowel syndrome according to Rome II criteria and small intestinal bacterial overgrowth
    Disease: Version SOC Term Classification Code Term Level
    6.1 10023003 PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-012592-10 Sponsor Protocol Number: 09-057 Start Date*: 2009-07-23
    Sponsor Name:CHU Caen
    Full Title: Méthode d’évaluation de l’aptitude à la conduite chez des patients souffrant de pathologies de l’éveil: cirrhose avec ou sans encéphalopathie (AutoSoP "foie").
    Medical condition: cirrhose
    Disease: Version SOC Term Classification Code Term Level
    9.1 10019641 Hepatic cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-005348-92 Sponsor Protocol Number: PROGASS Start Date*: 2013-02-19
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
    Full Title: PROGASS PRucalopride On the GAstreonteric transit in Systemic Sclerosis
    Medical condition: Sysemic sclerosis with gastroenteric involvement (constipation)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10017947 Gastrointestinal disorders SOC
    Population Age: Adults Gender: Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000239-29 Sponsor Protocol Number: PEC19156 Start Date*: 2021-07-09
    Sponsor Name:BIOGAIA PHARMA
    Full Title: A randomized placebo-controlled study to assess safety and preliminary efficacy of BGP345A in patients with constipation due to the use of opioid-based medications for the management of chronic non...
    Medical condition: Opioid induced constipation
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-004473-32 Sponsor Protocol Number: IDN-6556-14 Start Date*: 2016-12-27
    Sponsor Name:Conatus Pharmaceuticals Inc.
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hyperten...
    Medical condition: Non-Alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension
    Disease: Version SOC Term Classification Code Term Level
    20.1 10019805 - Hepatobiliary disorders 10036200 Portal hypertension PT
    22.0 10019805 - Hepatobiliary disorders 10053219 Non-alcoholic steatohepatitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000854-24 Sponsor Protocol Number: VE-CIP2001/2021 Start Date*: 2021-12-21
    Sponsor Name:ALFASIGMA S.P.A.
    Full Title: Velusetrag for the treatment of Chronic Intestinal Pseudo-Obstruction (CIPO). A multicenter double-blind, placebo-controlled, cross-over, multiple (n=1) trial.
    Medical condition: Chronic intestinal pseudo-obstruction (CIPO) is a rare, severe condition characterized by an impairment of coordinated propulsive activity in the intestinal tract resulting in a clinical picture si...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10017947 Gastrointestinal disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005969-13 Sponsor Protocol Number: AXA1665-101 Start Date*: 2021-08-11
    Sponsor Name:Axcella Health, Inc.
    Full Title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of AXA1665 in Subjects With Liver Cirrhosis and Prior Overt Hepatic Encephalopathy (EM...
    Medical condition: Overt Hepatic Encephalopathy in Subjects with Liver Cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10019660 Hepatic encephalopathy PT
    20.0 100000004871 10024667 Liver cirrhosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) PL (Completed) HU (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-002041-36 Sponsor Protocol Number: POLARIS2009-001 Start Date*: 2011-11-15
    Sponsor Name:Polaris Group
    Full Title: A Randomized, Double-Blind, Multi-Center Phase 3 Study of ADI-PEG 20 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Fai...
    Medical condition: Advanced Hepatocellular Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10019829 Hepatocellular carcinoma recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Ongoing)
    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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