Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to determine whether treatment with antibiotics, which harm the gut flora, causes the immune system to be less effective.


Clinical Trial Description

Rationale: Sepsis ranks among the top ten leading causes of death worldwide. Most nonsurvivors die in a state of immunosuppression. The gut microbiota exerts numerous beneficial functions in the host response against infections. Gut flora components express microorganism-associated molecular patterns (MAMPs) such as lipopolysaccharide (LPS), which are recognized by pattern recognition receptors (PRRs) expressed by neutrophils and macrophages. MAMPs from the intestinal microbiota constitutively translocate to the circulation and prime bone marrow derived neutrophils via PRRs. Antibiotic treatment, which is standard of care for all patients with sepsis, depletes the gut microbiota and leads to a diminished release of MAMPs and other bacteria derived products. This causes diminished priming of systemic immunity, which may attribute to sepsis associated immunosuppression and an increased susceptibility to invading bacteria.

Objective: To investigate the role of the gut microbiota in the systemic priming of immune effector cells during human endotoxemia

Study design: Randomized, between- and within-subject-controlled intervention study in human volunteers

Intervention: All subjects will receive lipopolysaccharide (endotoxin; 2 ng/kg bodyweight) intravenously to induce experimental endotoxemia. Eight subjects will be pretreated with broad spectrum antibiotics (ciprofloxacin, vancomycin, metronidazole) for seven days (washout period of 36 hours before endotoxemia), in order to deplete the gut microbiota. Blood and faeces will be sampled before, during and after endotoxemia. ;


Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


NCT number NCT02127749
Study type Interventional
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact
Status Completed
Phase N/A
Start date June 2014
Completion date December 2015

See also
  Status Clinical Trial Phase
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT02922673 - The Effects of Acetylsalicylic Acid on Immunoparalysis Following Human Endotoxemia N/A
Completed NCT01766414 - In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II Phase 3
Completed NCT04130321 - Demonstration of the Prebiotic-like Effects of Camu-camu Consumption Against Obesity-related Disorders in Humans N/A
Completed NCT02612480 - Ticagrelor in Human Endotoxemia Response to Human Endotoxemia N/A
Completed NCT01474629 - Probiotic Sport Study N/A
Completed NCT00246714 - Pathophysiology and Clinical Relevance of Endotoxin Tolerance in Humans Phase 1
Recruiting NCT06147440 - Different Dietary Patterns N/A
Recruiting NCT03901807 - Safety and Efficacy of Polymyxin B Hemoperfusion (PMX) for Endotoxemic Septic Shock in a Randomized, Open-Label Study N/A
Completed NCT03754504 - Effects of Cranberry Powder Supplements on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03800277 - Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health N/A
Completed NCT00785018 - In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia N/A
Recruiting NCT00413348 - Type 2 Diabetes and the Effect of Probiotics N/A
Recruiting NCT00413465 - Study of Renal Blood Flow During Human Endotoxemia N/A
Completed NCT00412906 - Study of Gene Activity in Fat and Muscle in Diabetics and Healthy Controls N/A
Completed NCT05752968 - Elevated Levels of Antibodies to Endotoxin Core in Hemodialysis Patients With Peripheral Artery Disease
Completed NCT01374711 - The Effects of Immunostimulation With GM-CSF or IFN-y on Immunoparalysis Following Human Endotoxemia N/A
Completed NCT00916448 - The Effects of Atazanavir-induced Hyperbilirubinemia During Human Endotoxemia N/A
Completed NCT00332267 - Cerebral Blood Flow and Metabolism During Hypoxia and Endotoxemia N/A
Completed NCT03482284 - Effect of Monosaccharides on Intestinal Barrier Function N/A