💬In plain words
What the trial is, and whether it could suit you
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.
This 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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Voluntary written informed consent obtained prior to any study procedure
* Healthy, with no gastrointestinal or psychological complaints
* Age 18-45 years
* BMI 18.5-27 kg/m2
* Proficiency in English and/or Dutch
Exclusion Criteria:
* History of previous or current neurological disorder (e.g., epilepsy, multiple sclerosis, migraine with aura)
* History of previous or current psychiatric disorder (e.g., depression, anxiety disorders, bipolar disorder, schizophrenia)
* History of previous or current gastrointestinal disorder (e.g., Crohn's disease, ulcerative colitis, irritable bowel syndrome)
* History of previous or current endocrine disorder (e.g., diabetes, thyroid disorders, polycystic ovary syndrome)
* 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)
* History of neuropsychiatric disorder (e.g., ADHD, autism spectrum disorder, learning disorder, Tourette's syndrome)
* History of major head trauma (e.g., concussion with loss of consciousness or long-term symptoms)
* History of severe infection (e.g., sepsis, pneumonia requiring hospitalization, meningitis, endocarditis, or other systemic infection requiring hospitalization, intravenous antibiotics, or intensive care)
* One or more diagnoses based on the Mini International Neuropsychiatric Interview (MINI)
* One or more diagnoses based on ROME-IV criteria for gastrointestinal disorders
* Any disorder that, in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol
* Any prior or concomitant treatment that might jeopardise the participant's safety or compromise the integrity of the study
* Participation in an interventional trial with an investigational medicinal product (IMP) or device
* 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)
* Use of psychotropic medication within the past year (e.g., antidepressants, anxiolytics, antipsychotics)
* Use of antibiotics within three months preceding the study
* Use of pre- or probiotics within one month preceding the study
* Current or recent (past month) infection (e.g., common cold, influenza, COVID-19)
* Recent (past month) vaccination
* Pregnant or lactating women
* Previous or current substance or alcohol dependence or abuse (\>2 units/day or \>14 units/week)
* Smoking
* Night-shift work
* Adherence to special diets (e.g., vegan, vegetarian, weight-loss, lactose-free, gluten-free)
* Previous experience with or knowledge of any of the cognitive tasks used in the study (questionnaires excluded)
* C-reactive protein higher than 0.5mg/dL on the day of the injection.
* Colour vision deficiency or colour-blindness
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