[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endotoxemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endotoxemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":70},"100647913","short-chain-fatty-acids-in-lypopolysaccharide-induced-inflammation-and-executive-function-100647913",false,"NCT07713641","Short-Chain Fatty Acids in Lypopolysaccharide-Induced Inflammation and Executive Function","Investigating the Role of Short-Chain Fatty Acids in Endotoxemia-Induced Inflammation and Core Executive Functioning: A Randomized, Triple-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Voluntary written informed consent obtained prior to any study procedure\n* Healthy, with no gastrointestinal or psychological complaints\n* Age 18-45 years\n* BMI 18.5-27 kg\u002Fm2\n* Proficiency in English and\u002For Dutch\n\nExclusion Criteria:\n\n* History of previous or current neurological disorder (e.g., epilepsy, multiple sclerosis, migraine with aura)\n* History of previous or current psychiatric disorder (e.g., depression, anxiety disorders, bipolar disorder, schizophrenia)\n* History of previous or current gastrointestinal disorder (e.g., Crohn's disease, ulcerative colitis, irritable bowel syndrome)\n* History of previous or current endocrine disorder (e.g., diabetes, thyroid disorders, polycystic ovary syndrome)\n* History of immune system disorder, including inflammatory, autoimmune, or severe allergic conditions (e.g., rheumatoid arthritis, lupus, celiac disease, or severe allergies such as anaphylaxis)\n* History of neuropsychiatric disorder (e.g., ADHD, autism spectrum disorder, learning disorder, Tourette's syndrome)\n* History of major head trauma (e.g., concussion with loss of consciousness or long-term symptoms)\n* History of severe infection (e.g., sepsis, pneumonia requiring hospitalization, meningitis, endocarditis, or other systemic infection requiring hospitalization, intravenous antibiotics, or intensive care)\n* One or more diagnoses based on the Mini International Neuropsychiatric Interview (MINI)\n* One or more diagnoses based on ROME-IV criteria for gastrointestinal disorders\n* Any disorder that, in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol\n* Any prior or concomitant treatment that might jeopardise the participant's safety or compromise the integrity of the study\n* Participation in an interventional trial with an investigational medicinal product (IMP) or device\n* Current or recent (past month) prescribed medication use, with particular attention to cardiovascular drugs, steroids, NSAIDs, and centrally-acting drugs (excluding isolated over-the-counter use such as ibuprofen or paracetamol, and hormonal contraceptives in women)\n* Use of psychotropic medication within the past year (e.g., antidepressants, anxiolytics, antipsychotics)\n* Use of antibiotics within three months preceding the study\n* Use of pre- or probiotics within one month preceding the study\n* Current or recent (past month) infection (e.g., common cold, influenza, COVID-19)\n* Recent (past month) vaccination\n* Pregnant or lactating women\n* Previous or current substance or alcohol dependence or abuse (\\>2 units\u002Fday or \\>14 units\u002Fweek)\n* Smoking\n* Night-shift work\n* Adherence to special diets (e.g., vegan, vegetarian, weight-loss, lactose-free, gluten-free)\n* Previous experience with or knowledge of any of the cognitive tasks used in the study (questionnaires excluded)\n* C-reactive protein higher than 0.5mg\u002FdL on the day of the injection.\n* Colour vision deficiency or colour-blindness",true,"ALL","18 Years","45 Years",{"count":21,"type":22},56,"ESTIMATED","INTERVENTIONAL",[25],"NA","Short-chain fatty acids (SCFAs) are substances produced by gut bacteria when they ferment dietary fiber. They can act as signals between the gut and the brain and may help regulate the body's immune and stress responses. Earlier work has shown that delivering SCFAs to the colon can lower the stress hormone response to a mental stress task in healthy people, and laboratory studies suggest SCFAs can reduce inflammation. However, it is not yet known whether SCFAs can reduce inflammation in humans, or whether doing so protects mental performance.\n\nThis study uses a controlled, acute, and short-lasting challenge. Healthy adults receive a single, low dose of a bacterial substance called lipopolysaccharide (LPS) through a vein. LPS briefly activates the immune system and causes mild, flu-like symptoms (such as fatigue, headache, and feeling unwell) that pass on their own within a few hours. It does not cause a real infection.\n\nParticipants are randomly assigned to take either SCFA capsules or inactive placebo capsules on the morning of the test day, before the LPS challenge. Neither the participants, the researchers running the visit, nor the researchers analyzing the results know who received which capsules until the study is complete (triple-blind).\n\nThe main goal of the study is to test whether SCFAs, compared with placebo, reduce the inflammatory response to LPS, measured by markers of inflammation in the blood. The study also examines whether SCFAs reduce the associated sickness symptoms and whether they protect performance on tasks that measure core executive functions: the ability to keep relevant information in mind (working memory), the ability to hold back automatic responses or thoughts (inhibition), and the ability to switch flexibly between tasks or rules (cognitive flexibility). Blood, saliva, and stool samples are collected to measure inflammation markers, SCFA levels, stress hormones, and gut bacteria.\n\nParticipants attend a screening visit, a test day with monitoring for several hours, and a short follow-up visit the next day.",[28,29,30],"Endotoxemia","Inflammation","Executive Function (Cognition)",[32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57],"scfa","short-chain fatty acids","butyrate","proprionate","acetate","lypopolysaccharide","lps","endotoxemia","lps challenge","experimental","inflammation","experimental inflammation","experimental endotoxemia","systemic inflammation","gut-brain axis","microbiota","microbiota-gut-brain axis","executive function","working memory","inhibition","cognitive inhibition","response inhibition","cognitive flexibility","task switching","healthy volunteers","sickness behaviour","RECRUITING","2026-07-14",{"date":61,"type":62},"2026-07-20","ACTUAL",{"date":64,"type":62},"2025-10-24",{"date":66,"type":22},"2027-03-30",{"name":68,"class":69},"Universitaire Ziekenhuizen KU Leuven","OTHER",1,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":16,"sex":78,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":84,"conditions":85,"keywords":92,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":70},"100564074","phase-4-immunomodulatory-effects-of-dexamethasone-tocilizumab-and-anakinra-during-experimental-human-endotoxemia-100564074","NCT06624436","Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia","DEDICATE-LPS","Inclusion Criteria:\n\n* Male subjects aged ≥18 and ≤35 years\n* Body mass index (BMI) ≥18 and ≤30 kg\u002Fm2\n* Healthy (as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine clinical laboratory parameters)\n* Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.\n\nExclusion Criteria:\n\n* Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs\n* Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients\n* History of chronic headache or previous post-dural puncture headache (PDPH)\n* History or signs of severe atopic syndrome (asthma, rhinitis with medication and\u002For eczema)\n* History of any disease associated with immune deficiency\n* History of cancer in the last 5 years (excluding localised skin cancer or carcinoma in situ)\n* History or signs of haematological disease\n* History or signs of thromboembolic disorders\n* History of peptic \u002F gastric ulcer disease\n* History of psychiatric disorders\n* Thrombocytopenia (\\<150\\*109\u002FmL) or anaemia (\\<8.0 mmol\u002FL)\n* History, signs or symptoms of cardiovascular disease, in particular:\n\n  * Prone to vagal collapse\n  * History of atrial or ventricular arrhythmia\n  * Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch block\n  * Hypertension (defined as RR systolic \\> 160 or RR diastolic \\> 90 mmHg)\n  * Hypotension (defined as RR systolic \\< 100 or RR diastolic \\< 50 mmHg)\n* Renal impairment (defined as plasma creatinine \\>120 μmol\u002FL)\n* Liver enzyme abnormalities (above 2x the upper limit of normal)\n* Signs of infection (CRP \\> 20 mg\u002FL, white blood cells \\> 12x109\u002FL or\n\n  * lt; 4x109\u002FL)\n* Clinically significant acute illness, including infections or trauma, within 1 month prior to the first LPS challenge\n* Previous (participation in a study with) endotoxin (LPS) administration\n* Participation in an experimental intervention or drug trial within 3 months prior to the first LPS challenge\n* Any vaccination or blood donation within 1 month prior to the first LPS challenge\n* Recent hospital admission or surgery with general anaesthesia within 3 months prior to the first LPS challenge\n* Use of recreational drugs within 2 weeks prior to the first LPS challenge\n* Suspected of not being able to comply with the trial protocol\n* Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and\u002For take part in the study","MALE","35 Years",{"count":81,"type":22},52,[83],"PHASE4","The goal of this clinical trial is to investigate the immunomodulatory effects of the drugs dexamethasone, tocilizumab and anakinra in healthy male subjects aged 18 to 35 undergoing experimental endotoxemia. The main questions it aims to answer are:\n\n* What are the effects of these drugs on the development of immunoparalysis in a repeated human endotoxemia model?\n* What is the extent of the neuroinflammatory response and how do these drugs affect neuroinflammation in a repeated human endotoxemia model?\n\nResearchers will compare these drugs to a placebo (a look-alike substance that contains no drug).\n\nParticipants will visit the Intensive Care research department on two or five occasions (screening included):\n\n* The intervention group will receive an LPS challenge twice, with a week in between. Before the first LPS challenge, one of the described drugs will be administered. Blood, saliva and tear fluid will be collected regularly during the LPS challenge. Cerebrospinal fluid will also be collected through a catheter in the spinal cord.\n* The control group will not receive an LPS challenge or drug administration and will have only one study day. During this day, blood, saliva, tear fluid and cerebrospinal fluid will be collected as regularly as during the LPS challenge of the intervention group.\n\nDuring an LPS challenge, the investigators mimic blood poisoning by giving an endotoxin, also called LPS. This is a small part of the cell wall of a bacteria. This will cause transient flu-like symptoms for 3-4 hours.",[86,87,88,28,89,90,91],"Sepsis","Neuroinflammatory Response","Immunosuppresion","Anakinra","Dexamethasone","Tocilizumab",[86,93,94,95,89,90,91,96,97,98],"Immunosuppression","Systemic inflammation","Neuroinflammation","Human endotoxemia","Immunoparalysis","Hyperinflammatory response","2025-04-01",{"date":101,"type":62},"2025-04-04",{"date":103,"type":62},"2024-10-24",{"date":105,"type":22},"2025-12",{"name":107,"class":69},"Radboud University Medical Center"]