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Endotoxemia clinical trials

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NCT ID: NCT06203015 Recruiting - Clinical trials for Major Depressive Disorder

The Relations Among Endotoxin, Inflammatory Cytokines, Cognitive Markers and Brain MRI Changes in Subjects With Depressive Disorder

Start date: June 1, 2022
Phase:
Study type: Observational

Major depressive disorder (MDD) is a chronic mental illness, with 60% lifetime risk of recurrence after the first MDD episode. Despite available treatment options for MDD, only about half to two-thirds of patients respond to first-line antidepressant treatment, and only 30% to 45% of patients achieve remission. Scholars assume that this low remission rate and high rate of treatment resistance are due to the polyetiological nature of the disease, the heterogeneity of the clinical picture of depression, and the lack of biomarkers to stratify MDD subtypes. The aetiology of MDD, although researched extensively, remains unclear. None of the known mechanisms alone explains the pathogenesis of depression, meaning that the interplay of several factors contributes to the development of MDD. Accumulated scientific evidence has supported the importance of the immune system in the etiopathogenesis of MDD. Until now, the cause of the low-grade inflammation observed in this subgroup of MDD patients has been unclear. In the proposed study, the investigators will test a new hypothesis of the immune theory of the development of MDD: the endotoxin hypothesis of neurodegeneration. This hypothesis states that endotoxin, causes or contributes to neurodegeneration. Blood plasma levels of LPS are normally low but are elevated during infections, gut inflammation, gum disease, and neurodegenerative diseases. Dysbiosis may promote increased intestinal permeability ("leaky gut"), which leads to bacterial translocation across the intestinal barrier and into the circulation, thus forming of LPS and LPS-binding protein complex, which triggers the secretion of cytokines. Data suggest that LPS-induced peripheral inflammation can activate neuroinflammation. However, it is not known whether a low-level persistent presence of LPS in the circulatory system can cause low-grade chronic neuroinflammation leading to neurodegeneration and/or symptoms of MDD. Based on existing preclinical and clinical research data, the investigators hypothesise that an increase in blood plasma endotoxin and peripheral cytokines induce BBB dysfunction, neuroinflammation and neurodegenerative processes in specific etiologically relevant structures of the brain and cause clinical manifestation of depressive symptoms and cognitive damage. In this study the investigators are also going to investigate the effects of single nucleotide polymorphisms of four genes in relation to blood plasma endotoxin and peripheral cytokines concentrations and clinical manifestation of MDD.

NCT ID: NCT06147440 Recruiting - Diet, Healthy Clinical Trials

Different Dietary Patterns

Start date: October 20, 2023
Phase: N/A
Study type: Interventional

The aim of the present study is to determine the effects of different standardized dietary patterns on general health markers, intestinal function, immune response and affective processes/ cognitive skills in healthy subjects.

NCT ID: NCT05776329 Completed - Obesity Clinical Trials

Dietary Intervention to Reduce Metabolic Endotoxemia

Start date: April 14, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized clinical trial is to compare an antiinflammatory and environmentally friendly dietary strategy (AIA-D) designed based on the planetary health diet recommendations translated to the regional context and including nutrients related to antiinflammatory responses with an active control diet based on general healthy diet recommendations (CONV-D) in adults from 18 to 50 years of age with obesity (body mass index ≥30 kg/m2). The main questions it aims to answer are: - If the intervention with AIA-D will cause a significant decrease at the end of the intervention (six weeks) in lipopolysaccharide-binding protein (LBP) compared to CONV-D. - If intervention with AIA-D will cause a significant increase at the end of the intervention (six weeks) in the relative abundance of two specific bacteria genera (AM and FP) when compared to CONV-D. Participants will: - Sign the informed consent. - Provide two peripheral blood samples (taken by our trained professionals). - Provide two samples of feces. - Allow anthropometric (body weight, height, hip and waist circumferences) blood pressure measurements on two occasions. - Respond to 24 h dietary recall on two occasions. - Attend the 1-hour group sessions requested (three for AIA-D and one for CONV-D). - Follow the dietary recommendations provided. - Be willing to participate in social media groups to receive information and follow up during the six weeks of the intervention. Researchers will compare an antiinflammatory and environmentally friendly strategy (AIA-D) with an active control diet (CONV-D) based on general healthy diet recommendations to see if AIA-D decreases metabolic endotoxemia measured through LBP serum levels and increase the relative abundance of AM and FP, compared to CONV-D.

NCT ID: NCT05752968 Completed - Clinical trials for Peripheral Arterial Disease

Elevated Levels of Antibodies to Endotoxin Core in Hemodialysis Patients With Peripheral Artery Disease

Start date: May 3, 2023
Phase:
Study type: Observational

Background Peripheral arterial disease (PAD) and its relevant complications are more common in hemodialysis (HD) patients. The potential association regarding chronic kidney disease dysbiosis, inflammation and metabolic endotoxinemia in HD patients is unknown. A cross-sectional study will be carried out the evaluate the possible association endotoxin core antibody with asymptomatic PAD in a cohort of HD patients. Methods This cohort study enrolled 500 HD patients treated at a single center in Taichung city. Fasting blood samples will be collected to determine biochemical data Endotoxin core antibody levels and other related biomarkers. By the automatic oscillometric method, the ankle-brachial index (ABI) was measured. Low ABI was defined as any value < 0.9.

NCT ID: NCT05570643 Completed - Clinical trials for Sepsis, Endotoxemia, Immunosuppression

The Effects of Human Endotoxemia on Functional Capacity of Hematopoietic Stem and Progenitor Cells

LPS-BM
Start date: January 5, 2018
Phase: N/A
Study type: Interventional

We will investigate whether human endotoxemia induces changes in human bone marrow cells and their downstream effector cells. To comprehensively investigate underlying mechanisms behind functional and transcriptional changes in these cell types, we will use state-of-the-art systems biology techniques, including single cell transcriptomics (epi)genetics, and metabolomics.

NCT ID: NCT05407090 Recruiting - Clinical trials for Bariatric Surgery Candidate

The Effect of Probiotics on Systemic Inflammation and Metabolic Endotoxemia in Patients Undergoing Bariatric Surgery

Start date: August 2, 2021
Phase: N/A
Study type: Interventional

This study explores the effects of probiotic administration on the outcomes of surgical treatment, and also on the state of the intestinal microbiota and the intestinal barrier. The study protocol is designed as a randomized double-blind placebo-controlled clinical trial. Patients qualified for bariatric surgery will be randomized to receive probiotics or a placebo for 12 weeks. Researchers are going to evaluate changes in intestinal microbiota, epithelial permeability, weight loss, postoperative complications, and serum parameters reflecting inflammation, metabolic profile, and metabolic endotoxemia.

NCT ID: NCT05318183 Active, not recruiting - Inflammation Clinical Trials

Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components

Start date: January 27, 2022
Phase: N/A
Study type: Interventional

This study will investigate the gut microbiota-mediated effects of whole wheat consumption on human health in adults with pre-diabetes. Participants will complete two phases of intervention in random order in which they will consume either whole wheat bread (4 servings) or white bread a day for two weeks prior to collecting specimens (stool, urine, and plasma/serum).

NCT ID: NCT05260099 Withdrawn - Clinical trials for Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria

Remove LPS Registry

Start date: November 2022
Phase:
Study type: Observational [Patient Registry]

This registry will collect and validate regulatory-grade real-world data (RWD) on the usage of the LPS-Adsorber and the outcomes from using the LPS-Adsorber in various patient populations (various sub-registries) that also have suspected endotoxemia. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.

NCT ID: NCT04920565 Recruiting - Clinical trials for Multiple Organ Dysfunction With Severe Endotoxemia

Efficacy and Safety of Hemoperfusion With Polymyxin B in Septic Shock Associated With Severe Endotoxemia in Cardiac Surgery Patients (РМХ vs SS)

??? vs SS
Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Sepsis is a state of multiple organ dysfunction caused by a generalized immune-inflammatory response of the body to an infectious agent, with pronounced heterogeneity and interchangeability of clinical and laboratory manifestations. Violation of autoregulation and multiple organ dysfunctions in case of not timely started and / or ineffective therapy lead to the development of multiple organ failure and thanatogenesis in 40-90% of cases. At the moment, there is no standardized approach to the treatment of the entire pool of sepsis patients. Pharmacological effects on receptors for interleukins and endotoxin, antibiotic therapy and immunoprotection do not allow taking the process under complete control. The pathogenesis and clinical diversity of manifestations dictates the need for a personalized approach based on identifying a group of patients with homogeneous characteristics and the course of the process, where one or another technique would have the greatest benefit. The choice of tactics for extracorporeal therapy should be based on early support of organ function and consistent elimination of high concentrations of trigger compounds (endotoxin, other metabolic products of microorganisms and products of cytolysis of a macroorganism), as well as aimed at minimizing the loss of proteins and immune complexes. The aim of this clinical study was to assess the efficacy and safety of the selective adsorption of endotoxin in patients with severe multiple organ dysfunction after complicated cardiac surgery.

NCT ID: NCT04788680 Completed - Dietary Habits Clinical Trials

Effects of Non-calorie Sweeteners, Mono- and Disaccharides on Intestinal Barrier Function

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

The aim of the present study is to determine the effect of non-nutritive sweeteners on intestinal barrier function and inflammatory markers in healthy subjects in comparison to mono- and disaccharides.