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Microbiome clinical trials

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NCT ID: NCT04136470 Recruiting - Melanoma Clinical Trials

BioForte Technology for in Silico Identification of Candidates for a New Microbiome-based Therapeutics and Diagnostics

Start date: April 1, 2019
Phase:
Study type: Observational

The goal of the project is to develop and validate the BioForte technology. Its main functionality should be to in silico determine candidates for novel microbiome-based therapeutics and diagnostics. Key challenge to be solved using the technology is to detect the differences in gut microbiome between oncology patients who respond to immunotherapies and the ones who do not respond to this treatment. This technology employs machine learning methods to replace the laboratory procedure for finding valuable genomic features. Such features can be crucial to identify differences between the two populations (e.g. responders vs non-responders) to target specific strains. The samples and data collected in this clinical study will be used for clinical validation of BioForte technology. For all patients treated with immunotherapy, stool collection will be performed per patient (one stool collection before setting up immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies). Samples will be sequenced by long-read sequencing technology. In parallel, we will also collect samples of peripheral blood samples (PBMC) and biopsy (FFPE).

NCT ID: NCT04100603 Recruiting - Clinical trials for Clostridium Difficile Infection

A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Clostridoides Difficile Infection

Start date: March 2, 2020
Phase:
Study type: Observational

This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.

NCT ID: NCT04046822 Recruiting - Obesity Clinical Trials

Effect of Liraglutide on Microbiome in Obesity

Start date: January 9, 2019
Phase: Phase 4
Study type: Interventional

The purpose of the trial is to assess whether the beneficial effect of liraglutide on weight is mediated by changes in the composition of the intestinal Microbiome. The main mechanisms of action of liraglutide were traced to a reduction in the secretion of glucagon and slowing gastric emptying resulting in decreased appetite and body weight. It also seems that liraglutide is capable of increasing the satiety signals thanks to a dual mechanism of stimulation and inhibition induced by medication. Pomc neurons (opiomelacortin) present in hypothalamic arcuate nuclei, stimulated by liraglutide, glucagon-like peptide- 1 (GLP-1) receptor expressed by inhibiting intensely appetite. At the same time through the GABAergic neuronal activity is inhibited neuropeptide Y(NPY) deputies to the production of orexins that are powerful promoters of appetite. Alterations in the composition of the human gut microbiome occur in metabolic disorders such as obesity, diabetes. Liraglutide has been reported to switch microbiome composition towards lean-related bacterial phylotypes in animal studies. This leads to hypothesize that the switch of microbiome by liraglutide may be one of the mechanisms through which liraglutide may exert its effect. In particular the investigators hypothesize that liraglutide could restore a healthy microbiome or at least improve the microbiome composition through slowing gastrointestinal motility. Moreover, the liraglutide-related change of microbiome could be an additional mechanism that contribute to the beneficial metabolic effect of liraglutide. To test this hypothesis the investigators will investigate if there will be any change of gut microbiome assessed as Firmicutes-to-Bacteroidetes ratio after liraglutide treatment. In order to understand if the change of gut microbiome after liraglutide treatment occurs as an association or contributes to the effect of liraglutide ,the investigators will correlate the Firmicutes-to-Bacteroidetes ratios with the changes of Body Mass Index, Body Composition, appetite parameters, chronic inflammation parameters, lipid profile and insulin resistance. All the subjects will follow the same diet in order to avoid any bias.

NCT ID: NCT03934021 Recruiting - Stroke Clinical Trials

Gut Microbiota in Acute Stroke Patients

Start date: July 1, 2018
Phase:
Study type: Observational

This study is to find out the significance of gut-microbiota in acute stroke patients, including their neurological, radiological outcomes as well as their stroke mechanisms.

NCT ID: NCT03026621 Recruiting - Microbiome Clinical Trials

Examining the Change in Microbiome Diversity and Urine Metabolites After Lignite Extract Use

Start date: January 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether or not 'Restore' lignite extract mineral supplement impacts the microbiome composition of the mouth and gut. Additionally, participant urine samples will be examined to determine whether or not 'Restore' mineral supplement impacts the composition urine biomarkers and toxins.