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Microbiota clinical trials

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NCT ID: NCT05125380 Recruiting - Cervical Cancer Clinical Trials

Cervical Cancer Screening by Self-sampling in a Cohort of Younger Women in Ethiopia

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

The overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC). Specific aims are the following: - To evaluate the algorithm using Visual Inspection with Acetic acid (VIA) and VIA together with Lugol's Iodine (VILI) as triage and to use HPV self-sample to follow up those treated and those with persisting HPV. - To evaluate the prevalence of Chlamydia trachomatis, Neisseria gonorrhoeae and other STIs in the cohort. - To determine immune response profiles in high-risk HPV-positive women who cleared, persisted, or developed Cervical Intraepithelial Neoplasia 2/3 (CIN). - To assess how specific cervicovaginal microbiota compositions are associated with HPV infection, cervical dysplasia, and cancer

NCT ID: NCT05120661 Completed - Obesity Clinical Trials

Elucidating the Role of Human Small Intestine Microbiota in Explaining Differences in Postprandial Glucose Responses

GLYSIMI
Start date: December 9, 2021
Phase: N/A
Study type: Interventional

It has been shown that person-specific factors, such as the fecal microbiome, influenced postprandial glycemia. The small intestine is the site of nutrient digestion and absorption. The small intestine microbiota is amendable by dietary changes, and plays a key role in host adaptability to dietary variations. The role of the human small intestine microbiota in regulating postprandial glycemic responses towards food products will be investigated. First a screening will take place with to choose the test products that elicit most differential glucose responses and to select subjects with differential postprandial response to the same food product. The study will be a 6-day randomized cross-over trial with two test days. Four test (food) products, each containing 50 gram carbohydrates, and an oral glucose tolerance test will be provided to participants. Twenty men or women (BMI≥25 kg/m2, 40-75 years old) will be included. The main study parameters/endpoints are the food product-induced plasma glucose responses (iAUC) and the small intestine microbiota.

NCT ID: NCT05051215 Recruiting - Microbiota Clinical Trials

Gut Microbiota and Nonpuerperal Mastitis

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

Nonpuerperal mastitis (NPM), mainly including Plasma cell mastitis (PCM) and Granulomatous mastitis (GM), which clinical presentation is an accessible and painful breast mass accompanied by skin redness and swelling, nipple retraction and fistula formation . Much progress has been made in exploring the etiology and pathogenesis of NPM, while the exact etiology remains unknown, NPM is thought to arise from interactions between genetic susceptibility factors, epigenetic effects, and various environmental factors. While microbiota as an environment factor to some inflammatory and autoimmune diseases accept widespread attention, if gut microbiota also as a risk factor for NPM, it is worthy to be considered.

NCT ID: NCT05008094 Enrolling by invitation - Parkinson Disease Clinical Trials

The Epidemiology of Parkinson's Disease in Croatia and the Influence of Genetic Factors and Microbiota on the Progression and Treatment Outcomes of the Disease (GiOPARK)

GiOPARK
Start date: May 1, 2020
Phase:
Study type: Observational

Parkinson's disease (PD) is the second most common neurodegenerative disease, which affects 2-3% of the general population above 65 years. There are significant differences in incidence depending on geographical location, race, and ethnicity. The exact cause of the disease is still unknown, but the role of genetic and environmental factors has already been established. Certain genetic forms of the disease make up for a small percentage, so it is thought that environmental factors have a more significant impact on the development of the disease. The incidence of PD is higher in people exposed to significant quantities of pesticides and traumatic brain injury, while there is a smaller incidence in smokers and people consuming more significant quantities of caffeine. The project will finish in four years, with the first 20 months dedicated to the first phase (genetic-epidemiological research), and the entirety of the 48 months for the second phase of the project (prospective clinical research). The main goal of the first phase of the project is to determine which genetic mutations are the ones most represented in the Croatian population afflicted with the familial form of PD. In the second phase the main goal is to determine the influence of genetic factors and microbiological factors on the disease's progression as well as on the treatment outcomes. Specific goals of this part of the project are to determine how many patients in the general population of PD patients present with a genetic disorder and which genes have a role in that disorder, as well as determine the composition of intestinal and oral microbiota both in the patient test group and the healthy control group. Furthermore, specific goals are to evaluate the effects of standard PD treatment on the composition of microbiota, neurodegeneration progression and the activity of neuroinflammation in the central nervous system (CNS) and to examine whether there is a link between the physiological and the pathophysiological function of microbiota, using markers of disease progression and glial activity. Last specific goal is to analyze potential pathological conformation protein forms that could be used as a biomarker in early stages of the disease and a biomarker of disease progression. The first phase of the study will provide the first epidemiologic data on the familial form of PD, as well as the mutations most represented in patients with PD in Croatia. Additionally, the prospective clinical study will contribute to enlightening the intertwined effects of genetic and environmental factors in the emergence and progression of the disease, as well as their effect on treatment outcome. Intestinal and oral microbiota composition analysis will determine whether there is a difference between PD and the healthy population while using the short-chain fatty acid profile will determine the metabolic differences between the two groups. Analyzing the markers of CNS homeostasis, inflammation, and neuroglial function will determine the progression of the disease and also correlate them to genetic factors as well as the microbiota function and composition. Analyzing the pathological conformation forms of alpha-synuclein could lead to the discovery of novel biomarkers in the early stages of the disease, as well as to follow the progression of the disease

NCT ID: NCT04959435 Recruiting - Microbiota Clinical Trials

Understanding the Role of Oral Microbiota in Behçet's Disease (BEHCETBIOT)

BEHCETBIOT
Start date: January 10, 2022
Phase:
Study type: Observational

Behçet's disease (BD) is a systemic vasculitis that affects, especially, young people. Although its etiology remains unexplained, data suggest that the inflammatory response during BD results from a disruption of the homeostasis of innate and adaptive immune responses in genetically predisposed people. The microbiota could play a triggering role in BD, in particular the salivary and dental plaque microbiota. The aim of the Behçetbiot study is therefore to establish microbial profiles of dental plaque, pathological (on the mouth ulcer) and non-pathological mucous membrane, salivary and digestive and to compare them with control subjects not suffering from BD, related to the first degree, of the same socio-cultural level and to determine whether dysbiosis is correlated with a local and systemic pro-inflammatory response, by measuring salivary level of pro-inflammatory cytokines and blood level of CRP, fibrinogen, orosomucoïd and haptoglobin, and to compare them with controls.

NCT ID: NCT04930276 Recruiting - Microbiota Clinical Trials

Diet-glucose-gut Microbiome Net in Women With GDM

Start date: March 5, 2021
Phase: N/A
Study type: Interventional

A prospective cohort study was conducted to :1. explore the effective of diet intervention on blood glucose control; 2. observe the changeable composition of microbiota; 3. seek the possible microbiome intervened to prevent GDM.

NCT ID: NCT04924712 Recruiting - Microbiota Clinical Trials

Cellules B et Microbiote Dans le SNI

Start date: January 18, 2022
Phase:
Study type: Observational

Idiopathic nephrotic syndrome (INS) is a clinical entity defined by the association of selective albuminuria resulting in hypoalbuminemia, and nonspecific glomerular lesions, called minimal change disease (MDC) for corticosteroid-sensitive forms and lesions of Focal Segmental Glomerulosclerosis (FSGS) for severe forms, generally corticosteroid-resistant (CR-INS) (Korbet 1995). The specific complication of this renal disease is its immediate recurrence on the graft (Dantal 1996, Dantal 1995) leading, in 50% of cases, to the failure of the transplantation, condemning these patients to dialysis for life. The origin of this syndrome is currently unknown, but a number of clinical observations tend to show an involvement of the immune system (Shaloub 1974). A number of studies have demonstrated a link between atopy, diet and nephrotic attacks (Lagrue 1982, 1984; Laurent 1987, 1988, 1989). Our team has also shown that plasma exchanges and immunoadsorptions can lead to total or partial remissions, supporting the evidence for the presence of a pathogenic plasma factor linked to immunoglobulins (Dantal 1991, Dantal 1994, Dantal 1998), previously suggested by the observation of immediate recurrence of the initial disease on the graft after renal transplantation (Hoyer 1972, Dantal 1995, Dantal 1996). Finally, more recently the use of anti-CD20 treatment specifically depleting B lymphocytes has made it possible to favorably treat a significant number of patients (Haffner 2009; CaraFuentes 2013; Iijima 2017; Siligato 2018). In 2009, the study of a patient with IPEX syndrome, who displayed INS/MCD, highlighted the importance of regulatory T cells in the pathogenesis of INS (Hashimura 2009). These results were corroborated by two studies showing regulatory T cell dysfunction in INS patients (Prasad 2015; Bertelli 2016). This alteration is also linked to allergies (Stelmaszczyk-Emmel 2015) and could be due to an aberrant microbiota or dysbiosis (Rodrigé 2011; Ohnmacht 2016). The hypothesis of a causality between dysbiosis, lymphocyte alteration and the onset of an INS has recently been raised (Uy 2015; Kaneko 2017). Two studies have shown intestinal dysbiosis in pediatric INS/MCD, with reduction of circulating Tregs (Tsuji 2018, 2020). Hypothesis and objectives Our hypothesis is that in INS/FSGS patients, the alteration of the immune system could be linked to an imbalance of the microbiota. Our objective is to compare the intestinal (and/or urinary) microbiota of the adult INS patient, in nephrotic attacks vs in remission with in parallel a complete monitoring of peripheral immune cells (T and B subtypes, NK, monocytic and dendritic cells) to estimate the possible change in the microbiota between the 2 disease states, and its potential impact on the immune system. The investigators will also compare the microbiota and the immune system of recurrent INS/FSGS patients after transplantation with non-recurrent post-transplant patients. Stages of the study This study should make it possible to 1 / bring together the cohort and the associated samples, necessary to achieve our goals; 2 / carry out the most exhaustive cytometric analysis of the peripheral sub-populations of these patients and 3 / analyze the intestinal and urinary microbiota. We will first collect a group of INS patients (n = 25) in nephrotic surge, then these same patients in remission. The second group to be collected will be a group of recurrent INS/FSGS patients after renal transplantation and a group of non-recurrent INS receiving the same therapeutic protocol (n = 5/5). As control groups, the investigators will collect proteinuric patients of other origin as well as healthy volunteers (n = 10/10). All patients and healthy individuals will sign an informative consent.

NCT ID: NCT04900532 Completed - Inflammation Clinical Trials

Effects of Supplementation With Tocotrienol on Chronic Kidney Disease Patients

Start date: May 1, 2019
Phase: N/A
Study type: Interventional

The objective of this study is to evaluate the supplementation with tocotrienol, a vitamin E compound on inflammation, oxidative stress, and microbiota on Chronic Kidney Disease patients.

NCT ID: NCT04843644 Not yet recruiting - Oral Mucositis Clinical Trials

Microbiota and Symptom Distress in Head and Neck Cancer Patients Receiving Radiotherapy

Start date: April 10, 2021
Phase: N/A
Study type: Interventional

The investigators plan to conduct a 3-year pioneering care research project for mucositis in cancer patients. These include: (1) an analysis of the incidence and severity of mucositis, severity, treatment methods, and treatment costs; (2) an RCT comparing the effectiveness of honey, Taiwan green propolis, and usual care in mucositis of cancer patients; (3) monitoring of related symptom changes using a smart bracelet device; (4) a measurement of IL-1, IL-6, IL-10, and TNF, Microbiota in saliva, Microbiota in stool and (4) modeling of the trend of mucositis for alertness and search of essential parameters of the complications.

NCT ID: NCT04803838 Active, not recruiting - Atherosclerosis Clinical Trials

The Gut and Oral Bacteria, Atherosclerosis and Ischemic Stroke Study

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

The main aim of this project is to demonstrate an association between gut and oral microbiota and their metabolites to carotid atherosclerosis and risk of ischemic stroke. The investigators aim to show that these metabolite levels are diet-dependent (mainly egg yalk and red meat) and associated with specific types of microbiota. The investigators to assess serum microbiota metabolite levels as a predictor of stroke and plaque progression for patients with carotid atherosclerosis.