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Gut Microbiome clinical trials

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NCT ID: NCT06433310 Not yet recruiting - Gut Microbiome Clinical Trials

Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study

Start date: May 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes in fungal populations in the gut microbiome.

NCT ID: NCT06424691 Active, not recruiting - Eczema Clinical Trials

Infant Restore: Efficacy of Microbiome Analysis and Education

Start date: May 4, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to learn if a microbiome analysis, education, and recommendation program can improve gut health, reduce future health risks, and empower parents in their children's health in infants aged 0-3 months delivered via Cesarean section. The main questions it aims to answer are: Will the intervention increase bacteria considered beneficial, decrease the C- section microbiome signatures, promote a reduction in opportunistic pathogens, and improved functional potential for HMO digestion and SCFA production Will the intervention decrease microbiome signatures associated with atopic march conditions. Researchers will compare participants in the intervention arm, who will receive microbiome reports, personalized action plans, and educational materials, to participants in the control arm, who will receive microbiome results and educational materials after the study's completion, to see if the intervention leads to improved gut health and reduced risk of health conditions. Participants will: - Provide two microbiome stool samples three months apart. - Receive detailed infant gut health reports via the Tiny Health app. - Receive personalized action plans tailored to their infant's gut health needs. - Engage in gut health coaching sessions with a microbiome expert. - Receive an educational email series on infant gut health. - Complete a series of surveys/questionnaires on health history, symptoms, and diet. This study seeks to demonstrate that targeted microbiome interventions can significantly improve early infant gut health, leading to potential long-term health benefits. These benefits may include reduced healthcare costs by lowering the incidence of related chronic conditions. By establishing a foundation for mitigating these conditions, the intervention could consequently result in fewer doctor visits, reduced need for medications, and a lower incidence of hospitalizations over the first 3-4 years of the infant's life.

NCT ID: NCT06423508 Not yet recruiting - Gut Microbiome Clinical Trials

PRObing The Efficacy of Commercial Stage Storage Buffers and Evaluating Gut Metaproteome Variability Between Individuals

PROTEGI
Start date: June 3, 2024
Phase:
Study type: Observational

The study aims to assess the effectiveness of various commercial and non-hazardous buffers for the storage of human gut fecal samples over time. This evaluation will be conducted by comparing the performance of these buffers against directly frozen samples using metaproteomic analysis. The study is motivated by the need for standardized protocols for sample preservation in metaproteomic research, particularly focusing on protein preservation in fecal samples. By investigating proteomic, taxonomic, and functional identifications, the research seeks to provide insights into the reliability of these buffers as storage solutions. Additionally, the study plans to explore inter- and intra-individual variabilities at the proteome level by periodically collecting fecal samples from volunteers, complementing existing knowledge in metaproteomics. Overall, the study addresses a critical gap in the field and has the potential to enhance reproducibility and comparability across metaproteomic studies

NCT ID: NCT06404749 Recruiting - Stress Clinical Trials

Fungal Fiber for Gut Health

FUN4GUT
Start date: May 3, 2024
Phase: N/A
Study type: Interventional

This study compares effects of plant based fiber vs fungi based fiber on clinical outcomes related to gut function (immunity, emotions, stress) and explores the role of gut microbiome structure and function on individual responses.

NCT ID: NCT06304480 Not yet recruiting - Gut Microbiome Clinical Trials

Effect of The Substitution of Animal Protein by Soya-Based Fermented Product on Human Gut Microbiome

Start date: July 15, 2024
Phase: N/A
Study type: Interventional

There is a growing understanding of the functioning and interconnectedness of microbiomes in the food system which offers great potential for enabling the development of new solutions contributing to achieving important food and nutrition goals including those requested by FOOD 2030. Of relevance in this regard is the provision of sustainable and healthy protein sources. Because of the obvious environmental and climate concerns associated with the production of animal-derived protein, a transition is needed to healthier and more environment-friendly diets, including a moderate-level consumption of red and processed meat and greater emphasis on plant-based foods. As well as impact of meat production on the climate, it is well established that eating a diet rich in red meat promotes the growth of gut microbiome members that drive or exacerbate inflammation. Plant protein does not have these associations, and in fact it is often accompanied by fibre ingestion, which favours growth of health-promoting gut microbes. Replacing meat with plant protein offers the prospect of improving consumer health by improving the gut microbiome. The EU funded project MICROBIOMES4SOY will assess the effect of replacing animal protein with soya-derived protein on the human gut microbiome and whether this replacement can reduce the risk of inflammation-related diseases by gut microbiome modulation. This knowledge will provide a baseline for establishing new dietary pathways making use of soya protein and support dietary transition for EU citizens.

NCT ID: NCT06291571 Not yet recruiting - Liver Diseases Clinical Trials

Assessment of Microorganisms and Host Response In Liver Diseases

MILD
Start date: June 1, 2024
Phase:
Study type: Observational

The normal human gut is home to millions of microbes including bacteria, fungi, and viruses, collectively forming the gut microbiota, which exists in harmony within us. Much research is still required to fully understand the contribution of microbes resident in the large intestine in liver diseases. The liver receives blood from the gut carrying all the necessary nutrients needed for our body but also has to deal with toxins derived from the microbes residing in the intestines. The gut microbiota is altered in liver disease. We still do not know clearly how this change impacts liver function and the health of liver patients. The purpose of our study is to answer this question by assessing the gut microbiota using modern microbiological and molecular methods. By studying the alterations in the gut microbiota in patients with liver disease we can understand how they affect our immune system and metabolism. This will help design novel medicinal products to prevent and treat liver disease.

NCT ID: NCT06260579 Recruiting - Physical Activity Clinical Trials

Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity

PHOENIX-Kidney
Start date: November 14, 2022
Phase: N/A
Study type: Interventional

This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent.

NCT ID: NCT06231706 Recruiting - Gut Microbiome Clinical Trials

ZOE BIOME Study: Biotics Influence on Microbiome Ecosystem

Start date: January 26, 2024
Phase: N/A
Study type: Interventional

The differences observed in host gut microbiome communities between health and disease states, and between different dietary patterns, has led to an increase in the use of dietary modulations to influence microbiome composition, both in research and in commercial contexts. Two particular groups of gut-active compounds include prebiotics (providing a direct source of nutrition that can stimulate host-beneficial microbiota as they are indigestible to the host) and probiotics (providing a direct source of live microorganisms that may potentially colonise the gut after reaching the large intestine, thus altering gut microbiome dynamics). Using a randomised controlled parallel trial design, the ZOE BIOME Study aims to investigate the efficacy of prebiotic and probiotic compounds in improving health outcomes including gut microbiome composition, gastrointestinal symptoms, and cardiometabolic markers of lipaemic, glycaemic and inflammatory status in a remote setting. Further, consumption of high fibre supplements or food ingredients in combination with high carbohydrate meals has been shown to decrease the postprandial glycaemic response. To investigate the acute metabolic effects of prebiotic compounds , a randomised controlled crossover design postprandial study will be conducted. The ZOE BIOME Postprandial Study aims to investigate the efficacy of prebiotic compounds in improving acute postprandial glycaemic response, subjective feelings of hunger, satiety, mood, and subsequent eating behaviours.

NCT ID: NCT06207136 Not yet recruiting - Parkinson Disease Clinical Trials

Microbiome and Diet in Parkinson's Disease

PD-Diet
Start date: June 3, 2024
Phase: N/A
Study type: Interventional

The goal of this pilot study is to examine the feasibility and effects of an 18-month intervention diet compared to an active control diet (standard diet) in those living with Parkinson's Disease (PD), without dementia. Research has shown that eating components of Mediterranean diets are associated with a 30% lower risk to develop PD and a 40% lower mortality rate in those living with PD. Diet may influence the gut and microbiomes, thus may affect PD risk and progression. This study will examine how easy it will be to adhere to a certain type of diet for 18 months and what changes may occur in the gut microbiome and in PD symptoms on a specific diet during that time. The study will involve in-person study visits at UBC as well as online diet coaching sessions and online group cooking classes over Zoom. This is a randomized study, meaning that participants will be assigned by chance to either the Mediterranean-style diet group or the standard diet group for the duration of the 18 months. This pilot study will also examine recruitment rates and retention, in order to prepare for a larger future study.

NCT ID: NCT06206486 Recruiting - Gut Microbiome Clinical Trials

The Gut Microbiome and Serum Metabolites as a Biological Mechanism Underlying Pain in Kidney Transplantation

BIOME-KT
Start date: October 9, 2023
Phase:
Study type: Observational

Study Summary Nearly half (47%) of people with end-stage kidney disease (ESKD) whose kidney function is restored after kidney transplantation experience chronic pain compared to 19% of adults in the US general population. Pain is associated with comorbid fatigue, depression and anxiety, and withdrawal from usual physical and social activities; resulting in an inability to participate in and enjoy life. Severe pain can result in nonadherence to immunosuppression and treatment protocols and result in an increased risk of rejection, graft loss, and mortality. The role of symbiotic microbes (microbiota) in the gastrointestinal tract, and their functional genes (microbiome), is well established in diseases involving pain. Diet and stress play a major role in synthesis of signaling molecules critical to immunologic, metabolic, and endocrine pathways regulating chronic pain. Dietary patterns change dramatically after transplantation, as recipients move from a restricted "renal" diet to a regular diet, often resulting in increased consumption of foods high in sugars and fat. Moreover, psychological stress significantly impairs the function of the microbiome, initiating biological pathways involved in pain, leading to a disproportionate pain burden. Because the microbiome, serum metabolites, and pain are dynamic, our novel investigation will employ a prospective repeated measures design to interrogate the dynamic temporal relationships between the microbiome, metabolites associated with pathways regulating pain, transplantation factors (e.g. immunosuppression, kidney function), changing dietary patterns, and perceived stress, on pain scores before and after kidney transplantation. We posit the gut microbiome, and its byproducts, may partially explain the underlying biological mechanisms of pain Interference in kidney disease. We will address three aims: 1) To determine differential dynamic temporal relationships between microbial composition/functional genes and circulating serum metabolites in KTRs with pain vs no pain, 2) To determine the moderation effects of diet and perceived stress on dynamic temporal relationships between microbiome features, serum metabolites, and pain scores among KTRs, and 3) To use machine learning algorithms to identify host-microbial interactions that are causally linked to pain interference among KTRs. Because kidney function is restored, the kidney transplant model is powerful to study the longitudinal relationships between the microbiome, circulating metabolites and chronic pain in people with ESKD to develop patient-centered interventions to treat pain across the spectrum of CKD.