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New treatment option for Endotoxemia
Official title Short-Chain Fatty Acids in Lypopolysaccharide-Induced Inflammation and Executive Function
ClinicalTrials.gov ID: NCT07713641
What this study is testing
What is Lipopolysaccharide (LPS)?
Lipopolysaccharide (LPS) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endotoxemia.
Also referred to as LPS, Endotoxin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- History of neuropsychiatric disorder (e.g., ADHD, autism spectrum disorder, learning disorder, Tourette's syndrome)
See the full eligibility 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
- 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 treatment 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.