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Gut Microbiota clinical trials

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NCT ID: NCT06284928 Completed - Hypertension Clinical Trials

Gut Microbiota and New Hypertension

MIPHYP-CROSS
Start date: December 1, 2019
Phase:
Study type: Observational

This study aims to explore the gut microbiota patterns in patients newly diagnosed with hypertension, comparing them to those in non-hypertensive individuals. Utilizing cross-sectional analysis, it seeks to identify specific microbial profiles associated with hypertension, which could provide insights into the disease's pathogenesis and potential new avenues for treatment. The research focuses on analyzing fecal samples collected from both groups, using advanced genomic techniques to assess the diversity and abundance of gut bacteria. This investigation could contribute significantly to our understanding of the role gut microbiota plays in cardiovascular health and disease.

NCT ID: NCT06094894 Completed - Gut Microbiota Clinical Trials

Effects of Sucralose in Gut Intestinal Microbiota and Postprandial GLP-1

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Recently, it has been proposed that the consumption of non-nutritive sweeteners, including sucralose, it's not harmless and is related with metabolic effects. Some studies have reported that sucralose produces alterations in glucose homeostasis. In vitro studies indicate that sucralose can interact with sweet taste receptors (T1R2 and T1R3) in the intestine, thus increasing the expression of glucose transporters including the sodium-glucose cotransporter type 1 (SGLT1) and the glucose transporter 2 (GLUT2), increasing glucose absorption. This interaction with intestinal sweet taste receptors also generates an increase in the secretion of the incretins glucagon-like peptide type 1 (GLP-1) and the glucose-dependent insulinotropic polypeptide (GIP), which might enhance the postprandial insulin release. However, these results are preliminary and it's desirable to confirm if sucralose consumption is associated with glucose metabolism modifications using an appropriate methodological design and with gold standard methods. The aim of this triple-blind, placebo-controlled, parallel, randomized clinical trial is to confirm the changes in insulin sensitivity associated with sucralose consumption in humans, to identify whether these changes are in the liver or skeletal muscle and to investigate the pathophysiological mechanisms generating these changes. Specifically, we will investigate if sucralose generates a dysbiosis in the gut microbiota that could be related to insulin resistance by increasing concentrations of lipopolysaccharide, a toxin found in Gram-negative bacteria that triggers a low-grade inflammation known as metabolic endotoxemia. In addition, the changes in postprandial concentrations of GLP-1, glucose, insulin, and C-peptide due to the combination of sucralose with a mixed meal will be investigated. The results of this study will determine if sucralose consumption, frequently used as a non-nutritive sweetener, is associated to significant changes in glucose homeostasis in humans.

NCT ID: NCT05932433 Completed - Chronic Pain Clinical Trials

Effectiveness of Therapeutic Exercise on the Gut Microbiome in Chronic Widespread Pain Patients.

MiBioPain
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

This study aims to evaluate the effect of therapeutic exercise on the gut microbiome in chronic widespread pain patients. Our investigation purpose is to improve the quality of life of participants, reduce their disability and optimize their functionality. The intervention will last 6 weeks, with 2 face-to-face therapeutic exercise sessions guided by a professional and a 6-week post-intervention follow-up. The participation will require: 1. Attend the 12 therapeutic exercise sessions 2. Attend the 3 evaluations: at the beginning (A0), post intervention (A1) and +6 weeks after finishing the exercise program (A3). The items to be evaluated will be the following: 1. The Ronald Morris Disability Questionnaire (RMDQ) 2. Anxiety (State-Trait Anxiety Inventory (STAI)) 3. Depression: Beck Depression Inventory (BDI) 4. Quality of Life: SF-12 5. Pain: numerical scale (0-100) and The Brief Pain Inventory (BPI) 6. Sensory tests: heat pain threshold (HPT), pressure pain threshold (PPT) and pain modulation (CPM) 7. Perform a pre blood test on interleukins IL-18 and IL-1β This study involves the processing of personal data, so the researchers will guarantee confidentiality in their treatment at all times, complying with the personal data protection regulations, in particular, European Regulation 679/2016. , of April 27, general data protection, as well as Organic Law 3/2018, of December 5, Protection of Personal Data and Guarantee of Digital Rights. In order to maintain your privacy and anonymity during the research, only one person on the research team will know how names were assigned to a participation number.

NCT ID: NCT05628493 Completed - Gut Microbiota Clinical Trials

Gut Microbiota Analysis in IAI Patients With Sepsis-associated Liver Dysfunction

2022-11-09
Start date: January 3, 2022
Phase:
Study type: Observational [Patient Registry]

With the rapid development of intensive care medicine, the mortality of patients with sepsis has decreased over the past decade, but it is still the leading cause of death in intensive care unit (ICU). As an important immune and metabolic organ, the liver plays a crucial role in host defense against invading pathogens and endotoxins, as well as maintenance of metabolic and immunological homeostasis. Some studies indicate that sepsis-associated liver dysfunction (SALD) has a substantial impact on the severity and prognosis of sepsis. Intra-abdominal infections (IAI) are the second leading source of infection for sepsis after pneumonia in ICU, and are often related to high morbidity and mortality rates. Studies had found that the incidence of SALD in IAI patients was considerably higher than that of general population with sepsis. Moreover, the incidence of acute gastrointestinal injury (AGI) in IAI patients was also much higher than that in sepsis patients with other site infections, as well as the degree of AGI was more serious according to guidelines proposed by the European Society of Intensive Care Medicine (ESICM) in 2012. IAI can directly cause AGI, and a subset of patients usually progress to increased intra-abdominal pressure, which further aggravates AGI. The pathogenesis of SALD remains unclear so far, and its mechanism is complicated and elusive. Nevertheless, the unique anatomical structure of the liver make it has close association with the gut, growing evidence indicates that the gut microbiota and related metabolites are related to several liver disease. In case of sepsis, gut microbiota disorder and low microbial diversity can cause severe liver injury. An important mechanism for this phenotype is the gut-liver axis, which refers to gut microbial metabolites and nutrients are transported to the liver through the portal vein and hepatic artery to maintain the healthy metabolism of liver. Therefore, we initially conducted a retrospective study to investigate the relationship between the occurrence of AGI and SALD among IAI patients. Subsequently, a prospective study was performed to analyze and compare the diversity and composition of gut microbiota in IAI patients with or without SALD, respectively, and the dynamic changes in the gut microbiota during the first week after ICU admission were also investigated.

NCT ID: NCT05615961 Completed - Gut Microbiota Clinical Trials

Effect of Probiotics on Endurance Athletes' Microbiome at Rest and Post-race

Start date: July 1, 2022
Phase: N/A
Study type: Interventional

This study is intended to investigate the use of probiotics (LAB4 probiotics, Cultech, Port Talbot, Wales, UK) and the effect this has on gastrointestinal symptoms experienced during elite long-distance triathlon (ironman) competition, as well as the composition of the gut bacteria in the athlete. Long-distance triathlon events frequently induce gastrointestinal discomfort due to the duration of the event (8-17 hours), the intensity of the exercise and the ingestion of large amounts of sugars throughout the event. Data will be collected from athletes participating at the Kona ironman World-championships. Participants will supplement with either probiotic tablet, or placebo (sugar-pill) for 4-weeks prior to competition. Athletes will be both male and female age-group athletes from any qualifying age category (age categories are as follows: 18-24; 25-29; 30-34; 35-39; 40-44; 45-49; 50-54; 55-59; 60-64; 65-69; 70-74; 75-79; 80-84). The main investigation of the study will be the occurence/frequency/severity of gastrointestinal symptoms during training and competition between groups.

NCT ID: NCT05374980 Completed - Insulin Resistance Clinical Trials

The Effects of Yogurt on Gut Microbiome and Metabolism in H. Pylori.

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Helicobacter pylori is a common pathogen causing upper gastrointestinal diseases including gastric ulcer and gastric cancer. Recent epidemiological findings have also shown that it is also related to colon cancer, metabolic syndrome, gut dysbiosis, glycemic control and insulin resistance. The aim of this study is to investigate whether the gut microbiota and insulin resistance of patients with H. pylori infection are abnormal. In addition, whether drinking fermented milk product with probiotic reduces Helicobacter pylori, improves gut microbiota, and increases butyrate-producing bacteria and insulin resistance.

NCT ID: NCT05178524 Completed - Clinical trials for Hepatocellular Carcinoma

Clinical Study on BIFICO Accelerating Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma

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

On the basis of previous studies, this study intends to explore the effect of BIFICO on liver function recovery of patients with hepatocellular carcinoma (HCC) after surgery, so as to provide a new method for accelerating liver function recovery of HCC patients during perioperative period. This project is an open, randomized, blank-controlled clinical study. Liver resection patients were randomly divided into two groups, one group received continuous administration of BIFICO during perioperative period, and the dosage was controlled according to the instructions. The other group was a blank control. Stool samples were collected at three time points (before medication, before and after surgery) in two groups. Statistical analysis was performed to compare the differences of postoperative liver function and preoperative and postoperative gut microbiota between the two groups. Through this study, the investigators aimed to verify the beneficial changes of intestinal microflora in HCC patients with BIFICO during perioperative period .

NCT ID: NCT04994834 Completed - Gut Microbiota Clinical Trials

Characterization of the Gastrointestinal Microbiota in Term Newborn Infants After 4 Weeks Supplementation of Probiotics

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

A mono center, open label, pilot study in term newborn infants. The study will investigate the effect of supplementation with probiotics on the presence of total Bifidobacterium in the infant feces.

NCT ID: NCT04960878 Completed - Gut Microbiota Clinical Trials

The Effect of Synbiotics on the Upper Respiratory Tract Infection

Start date: October 5, 2020
Phase: N/A
Study type: Interventional

Gut microbiome manipulation to alter the gut-lung axis may potentially protect humans against respiratory infections. However, clinical trials of synbiotics, one of the microbiota-targeted intervention, in this regard is few. Therefore, this study aims to examine the effect of synbiotics on the incidence and severity of upper respiratory tract infection, gut microbiota composition and function, as well as biomarkers of immune function.

NCT ID: NCT04958460 Completed - ADHD Clinical Trials

Effect of Probiotics on ADHD

Start date: May 14, 2020
Phase: Phase 3
Study type: Interventional

Attention-Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder. Gut microbiome dysbiosis may be associated with the pathophysiology of ADHD. Investigators previously found the relative abundance of Sutterella stercoricanis were increased and Bifidobacterium bifidum were decreased in the ADHD group. Investigators hypothesize that ADHD patients receiving supplementary Bifidobacterium bifidum (Bf-688) is able to increase the proportion of Bf-688; inhibit the proportion of Sutterella; and improve ADHD symptoms.