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Gut Microbiome clinical trials

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NCT ID: NCT05580367 Recruiting - Critical Illness Clinical Trials

Gut-Brain-Axis/Lung-Brain-Axis and Mental Ill Health in Critical Illness

Start date: February 14, 2023
Phase:
Study type: Observational

Survivors of critical illness commonly experience long-lasting cognitive, mental health and physical impairments. Clinically significant symptoms of anxiety, depression, and post-traumatic stress disorder (PTSD) may occur in 40%, 34% and 20% of ICU survivors respectively, compared to 6%, 8% and 4% in the general population. These symptoms can persist for more than 8 years. Evidence shows the existence of a two-way, communication network between gut microbes and the brain referred to as the gut-brain axis. Changes in the microbiome and dysregulation of this communication network in relatively healthy people is associated with cognitive dysfunction and mood disorders such as anxiety and depression. The physiological stress associated with critical illness itself and many ICU interventions including the use of mechanical ventilation and medications such as antibiotics, antacids, vasopressors, and steroids can influence the balance of the gut microbiome and associated metabolites. This observation study aims to: 1. Quantify and measure dynamic changes in the gut microbiome and its metabolites during critical illness and recovery. 2. Explore the associations between microbiome and metabolomic changes during critical illness and psychological symptoms in the patient during their recovery. This knowledge will provide the potential to create interventions that alter the gut environment and microbiome both during and following a critical illness in order to reduce long-term adverse psychological effects. Examples of such potential interventions include dietary modifications with the use of prebiotics or probiotics.

NCT ID: NCT05463835 Completed - Anxiety Clinical Trials

RubusElite Efficacy Testing of a Novel High Protein, Berry Polyphenol Enriched Dairy Beverage

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

The RubusElite project is a multi-disciplinary project combining expertise in exercise science, nutrition, biochemistry, microbiology and food science across three institutions: University College Cork, Waterford Institute of Technology and Teagasc Food Research. This project has been funded by the Irish Department for Food, Agriculture and the Marines Food Institutional Research Measure (FIRM) initiative. The overarching aim of the RubusElite project is to provide an attractive, evidence-based performance and recovery food product for those undergoing frequent strenuous exercise in the form of a blackberry enriched, high protein dairy beverage. The process of developing this product will act as an exemplar model, providing best practice guidelines for the development of future functional foods in the performance nutrition space. This randomised controlled trial (RCT) will act as the ultimate test of efficacy of this functional food. It is envisaged that this RCT will assess the impact of a combined protein-polyphenol beverage on post-exercise recovery, exercise capacity, composition of the gut microbiome as well as central stress processing.

NCT ID: NCT05420987 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Effect of Jing Si Herbal Tea on Inflammation in Patients With Cardiovascular Disease

Start date: June 2022
Phase: N/A
Study type: Interventional

Jing Si herbal tea includes eight Chinese herbs: such as mugwort leaves, fish needle grass, Ophiopogon japonicus, platycodon, perilla leaves, chrysanthemum, and licorice. In vitro, these ingredients were found to be able to block the binding of SARS-CoV-2 and human ACE2 receptor, and further reduce the penetration ability of the virus. Now, Jing Si herbal tea liquid packets have obtained the special license for export from the Ministry of Health and Welfare in Taiwan. The aim of the study is to investigate (1) the effect of Jing Si herbal tea liquid on blood pressure, blood sugar, and cholesterol in patients with cardiovascular diseases. (2)The human gut microbiota change which is associated with TMAO production (3) The proinflammatory and inflammatory biomarkers change. We are going to recruit 100 participants from cardiovascular clinics, including patients with hypertension, hyperlipidemia, ischemic heart disease and diabetes, aged 20-75 years old. We exclude those who are cancer patients, have comorbidities with poor control, patients with eGFR< 40 ml/min/1.73m2, those who are pregnant, breastfeeding, and in their menstrual period when recruiting. The study has two parts. The first part is a pilot study with 20 subjects all take active Jing Si herbal tea. The second part is a double-blind randomized controlled study with 40 subjects in each arm.

NCT ID: NCT05400005 Recruiting - Sleep Clinical Trials

Impact of Different Types of Higher Dietary Protein Intake on Sleep Quality in Singapore Older Adults

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

Today, insufficient sleep has become a growing global problem. Sleep is essential to health and changes in sleep patterns are a part of the aging process. Inadequate and low-quality sleep also increases the risk for age-related cognitive decline and disease conditions. More importantly, due to COVID-19 health emergency, there is a significant increase of psychological distress and symptoms of mental illness and a worsening of quality of sleep. Therefore, there is an urgent need to investigate the way of improving sleep quality, in particular during and post COVID-19 period, in older adults. One of the possible strategies in improving sleep quality with lifestyle modification is having higher-protein diet. However, this effect has not been fully elucidated in older adults. In addition, the effect of type of dietary protein on sleep quality is inconclusive and there is no clinical trial which assessed the differential response in sleep quality between animal-sourced protein vs. plant-sourced protein. Therefore, the purpose of this research project is to assess the impact of different types of higher dietary protein intake on sleep quality in Singapore older adults. Findings from the proposed research will provide the scientific evidence of the beneficial effects of regularly consuming higher-protein diet on sleep quality in Singapore older adults. In addition, this research may validate the differential effect of different type of dietary protein on sleep quality. The results from the proposed research will also assist a practical guidance of nutritional behaviour changes providing sleep promoting effects to a large proportion of the Singapore population.

NCT ID: NCT05334888 Recruiting - Clinical trials for Cardiovascular Risk Factors

Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach

XCVD
Start date: August 29, 2022
Phase:
Study type: Observational [Patient Registry]

The XCVD study investigates the influence of sex hormones on the composition of the gut microbiome and the possible emergence of cardiovascular risk factors. It will follow 200 healthy transgender individuals for two years during their hormone replacement therapy (HRT) and analyze them for the possible emergence of cardiovascular risk factors in relation to changes in the gut microbiome, metabolome, and immunome. We would also like to phenotype cardiovascular disease.

NCT ID: NCT05303155 Recruiting - Clinical trials for Coronavirus Infections

The Association of Gut Microbiota With COVID 19 Infection in Children

Start date: April 14, 2022
Phase:
Study type: Observational

Although COVID-19 infects gastrointestinal tissues, little is known about the roles of gut commensal microbes in susceptibility to and severity of infection. The investigators will analyze the alterations in fecal microbiomes of patients with COVID-19 infection during hospitalization.

NCT ID: NCT05297383 Not yet recruiting - Obesity Clinical Trials

Pilot: Combining HIIT and n-3 PUFA Supplementation to Reduce Inflammation and Improve Metabolic Health (HIIT&PUFA)

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

The goal of this pilot study is to understand the combined effects of fish oil and exercise in obesity-associated inflammation acutely. We hypothesize that fish oil will improve gut bacteria profiles, which will in turn potentiate the benefits of an exercise program and reduce inflammation and metabolic risk.

NCT ID: NCT05266131 Completed - Hypertension Clinical Trials

The Effect of Sleep Apnea and Hypertension on Gut Microbiome

Start date: July 1, 2017
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) and hypertension are closely associated diseases. Here we characterized the differences in the gut microbiome which is affected by the two diseases, when the two diseases coexist or are present alone. Fifty-two consecutive patients who underwent polysomnography (PSG) were enrolled and divided into four groups: without OSA or hypertension (OSA0HT0), OSA without hypertension (OSA1HT0), hypertension without OSA (OSA0HT1), and with OSA and hypertension (OSA1HT1). Fecal specimens were collected for 16S rRNA sequencing and the characteristics of community richness, diversity, and composition of the gut microbiome and their relationship with disease were analyzed using bioinformatics methods.

NCT ID: NCT05090267 Recruiting - Cognition Clinical Trials

The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study

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

This project uses a hybrid trial design to evaluate two biomedical interventions targeting the gut-brain axis. One intervention is portable Transcutaneous Vagus Nerve Stimulator, tVNS, that is hypothesized to stimulate the autonomic nervous system, resulting in decreased inflammation and improved cognition. The second intervention is a probiotic supplement intended to replace gut bacteria that are associated with dysbiosis in persons with HIV and alcohol consumption.

NCT ID: NCT05014243 Not yet recruiting - Inflammation Clinical Trials

Targeted Metabolomics to Decipher Dietary Contributions to Pediatric Inflammatory Bowel Disease (IBD) - Main Study

TAMED IBD
Start date: August 1, 2023
Phase:
Study type: Observational

The overall goal of the study is to investigate the dietary differences between children with well-controlled inflammatory bowel disease (IBD) and those with active disease by using targeted food metabolomics. The utilization of the application of targeted metabolomics allows for the investigation of specific components of foods and their effects in IBD and inflammation, which may inform future dietary recommendations for IBD patients.