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Gastrointestinal Microbiome clinical trials

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NCT ID: NCT06305364 Recruiting - Clinical trials for Colorectal Neoplasms

Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue

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

This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance.

NCT ID: NCT06205862 Recruiting - Colorectal Adenoma Clinical Trials

Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)

Start date: April 9, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to learn about the efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection. The main questions it aims to answer are: - the efficacy and safety of fecal microbiota transplantation in reducing the recurrence rate of colorectal adenomas after endoscopic resection. - changes in the intestinal and mucosal microbiota of patients before and after endoscopic treatment. - changes in the intestinal and mucosal microbiota of patients before and after fecal microbiota transplantation. Participants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months).

NCT ID: NCT05961189 Recruiting - Exercise Clinical Trials

Influence of Short-Term Antibiotic Therapy on Exercise

Start date: September 1, 2023
Phase: Early Phase 1
Study type: Interventional

The gut microbiome refers to the trillions of bacteria that inhabit the stomach and other regions involved in the digestion of food, including the intestines. Compelling studies of animals (rodents) suggest that the health of the gut microbiome may influence skeletal muscle function and exercise performance. To date, there have been no similar observations reported in humans. A common experimental approach in animal studies to temporarily disrupt the gut microbiome is through the use of antibiotic therapies. Azithromycin is an antibiotic medicine prescribed to humans for the treatment of mild to moderate infections caused by bacteria. The purpose of the proposed project is to determine the influence of short-term (5-days) antibiotic therapy (azithromycin) on exercise performance in young, healthy adults. Treadmill exercise performance will be compared in two groups of adults before and after 5-days ingestion of azithromycin, or a placebo (something that has no physical effect).

NCT ID: NCT05692024 Recruiting - Colorectal Cancer Clinical Trials

COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER

COMMENCER
Start date: March 21, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is research study is assessing the effects of 6-g daily use of freeze-dried instant coffee on liver fat and fibrosis and the gut microbiome and metabolome in patients who have completed routine treatment (including surgery, chemotherapy and radiotherapy) for stage I-III colorectal cancer.

NCT ID: NCT05657730 Recruiting - Healthy Diet Clinical Trials

Study the Effect of Water Kefir Consumption on the Gut Microbiome in Healthy Adults

Start date: November 10, 2022
Phase: N/A
Study type: Interventional

The goal of this intervention study is to analyse the microbiota composition after the water kefir consumption. The main questions are to evaluate the potential probiotic drink can have beneficial effect on the gut microbiota. Participants will consume the water kefir for two weeks and microbiota will be analysed. Researchers will compare the microbiota composition before and after consumption.

NCT ID: NCT05636670 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

Assessment of Cognitive Function and Gut Microbiota Analysis in Real World Patients With Lupus Cerebrovascular Disease

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

Based on clinical manifestations, laboratory data and intestinal microflora detection, the cognitive function characteristics of patients with systemic lupus erythematosus and cerebrovascular disease and its relationship with intestinal microflora were analyzed to explore the possible pathogenesis of lupus cerebrovascular disease.

NCT ID: NCT05307367 Recruiting - Quality of Life Clinical Trials

Cancer-associated Muscle Mass - Molecular Factors and Exercise Mechanisms

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

Muscle mass loss is a common adverse effect of cancer. Muscle mass loss occurs with or without reduction in body weight. Cancer cachexia (CC) is the involuntary loss of body weight of >5% within 6 months and it occurs in 50-80% of patients with metastatic cancer. It is estimated that CC is a direct cause of up to 30% of all cancer-related deaths. No treatment currently is available to prevent CC, likely because the chemical reactions that causes of this devastating phenomenon in unknown. No treatment currently is available to prevent muscle mass loss in patients with cancer but is urgently needed as the reduced muscle mass and function is associated with impaired physical function, reduced tolerance to anticancer therapy, poor quality of life (QoL), and reduced survival. There is evidence of an interdependence between informal caregiver (e.g. spouse) and patient QoL. Thus, identifying caregiver distress and needs can potentially benefit QoL for patients with cancer cachexia. Despite the enormous impact on disease outcomes, it is not known why the loss of muscle mass and function occurs and very few studies have investigated the underlying molecular causes in humans. In particular, there is a severe lack of studies that have obtained human skeletal muscle and adipose tissue sample material. Such reference sample materials will be invaluable to obtaining in-depth molecular information about the underlying molecular causes of the involuntary but common muscle mass and fat mass loss in cancer. At a whole body level, cancer cachexia is associated with reduced sensitivity to the hormone insulin, high levels of lipids in the blood, and inflammation. Within the skeletal muscle, the muscle mass loss is associated with elevated protein breakdown and reduced protein build-up while emerging, yet, limited data also suggest malfunction of the power plants of the cells called mitochondrions. The role of malnutrition and how it contributes to weight loss is understood only to the extent of the observed loss of appetite and the reduced food intake because of pain, nausea, candidiasis of the mouth, and breathlessness. Evidence is increasing that the environment of the intestinal system could be implicated in cancer cachexia, yet, the possible effect of cancer and the cancer treatment on the intestinal environment is not understood. Thus, large and as yet poorly understood details of this syndrome precede a later weight loss. Exercise training could help restore muscle function and how the chemical reactions works in cancer. In healthy people, and patients with diabetes, cardiovascular disease, and obesity exercise potently improves health. Exercise has been thought to slow down the unwanted effects of cancer cachexia by changing the reactions mentioned above. Thus, there is a tremendous gap in our knowledge of how and if exercise can restore the cells power plants function, muscle mass, strength, and hormone sensitivity in human cachexic skeletal muscle. Tackling that problem and examining potential mechanisms, will enable us to harness the benefits of exercise for optimizing the treatment of patients with cancer. The data will provide novel clinical knowledge on cachexia in cancer and therefore addressing a fundamental societal problem. Three specific aims will be addressed in corresponding work packages (WPs): - investigate the involvement of hormone sensitivity of insulin and measure the chemical reactions between the cells in patients with lung cancer (NSCLC) and describe the physical performance and measure amount of e.g. muscles and adipose tissue across the 1st type of cancer treatment and understand how that is related to the disease and how patients and informal caregiver feel (WP1). - find changes in the chemical reactions in skeletal muscle, adipose tissue (AT), and blood samples in these patients, to understand how to predict how the disease will develop (WP2). - measure changes of skeletal muscle tissue in response to exercise and see if it might reverse the hormone insensitivity and improve muscle signaling and function (WP3). The investigators believe that: - the majority of patients with advanced lung cancer, at the time of diagnosis already are in a cachectic state, where they lose appetite, and have hormonal changes, and an overall altered chemical actions between the cells affecting both muscle mass and AT. The investigators propose that all this can predict how the disease will progress, and how patient- and informal caregiver fell and how they rate their quality of life. - lung cancer and the treatment thereof is linked with changes in the blood, the muscle tissues, and the adipose tissues, especially in patients experiencing cachexia, that could be targeted to develop new treatment. - exercise can restore the muscles and improve insulin sensitivity and improve the function of the cells power plants in patients with lung cancer-associated muscle problems.

NCT ID: NCT04855344 Recruiting - Clinical trials for Deep Brain Stimulation

Deep Brain Stimulation Therapy and Intestinal Microbiota

Start date: April 15, 2021
Phase:
Study type: Observational

This study aims to observe the changes of intestinal microbiota after deep brain stimulation (DBS) therapy for Parkinson's disease, and explore the role of intestinal microbiota in the neuroprotective effect of DBS.

NCT ID: NCT04359836 Recruiting - COVID-19 Clinical Trials

A Study to Explore the Role of Gut Flora in COVID-19 Infection

Start date: April 16, 2020
Phase:
Study type: Observational

This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.

NCT ID: NCT04302363 Recruiting - Clinical trials for Colorectal Neoplasms

Analysis of Intestinal Microflora Combined With DNA Methylation in Stool to Detect Colorectal Cancer

IMMDC
Start date: February 1, 2018
Phase:
Study type: Observational

Introduction: Colorectal cancer (CRC) has the third highest incidence rate and the fourth mortality rate in the world. Traditional colonoscopy as an invasive examination method cannot be widely used in screening for colorectal neoplasia. The fecal immunochemical test has some limitations in sensitivity. Also, race and regional differences may affect results. Abnormality in the composition of the gut microbiota has been implicated as a potentially important etiologic factor in the initiation and progression of colorectal cancer. Analyzing fecal flora and exfoliated cell genes may represent a new screening tool for colorectal cancer.This research aims to use 16S rRNA to compare differences in fecal flora between colorectal cancer patients and healthy controls. These data combined with DNA findings of fecal exfoliated cells may further clarify this difference to build a model for screening early colorectal cancer in Chinese people. Methods and analysis: In total, 300 patients with positive colonoscopy results and 200 health controls will be recruited. All participants will complete an information form and questionnaires. Fecal samples will be examined by 16S rRNA analysis. Gene methylation levels will be detected in fecal exfoliated cells. Models of related intestinal microbiota and methylation genes will be built. Receiver operating characteristic (ROC) curve analysis will be used to select some models with appropriate sensitivity and specificity.The models will be further validated by multicenter studys.