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Microbiome clinical trials

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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: NCT06250075 Completed - Gastric Cancer Clinical Trials

Effects of the Use of Probiotics on the Intestinal Microbiota of Patients With Gastric Cancer

PRONIC-G
Start date: December 12, 2020
Phase: N/A
Study type: Interventional

The objective of this randomized controlled, prospective clinical study, composed of 5 groups, G1, G2, G3, G4 and G5 is [Evaluate the intestinal microbiota profile, nutritional, immunological status and inflammatory profile, before and after total or partial removal surgery (gastrectomies) for gastric cancer, in a patient using probiotic supplements.] The main questions it aims to answer are: - probiotics are capable of modulating the immune response and microbiota in cancer patients who will undergo surgery - surgery itself alters the immunological pattern and microbiota of cancer patients Participants will be divided into groups for evaluation and the G1 intervention group will take probiotic capsules. The researchers will compare groups G1, G2 with G3 (negative control group) to see if there are differences between using probiotics or not, in controlling the immune response and if there are significant changes in their intestinal microbiota. Groups G4 and G5 will also be compared, where in these we will only measure the power of the use of probiotics in reducing surgical complications in the postoperative period.

NCT ID: NCT06203249 Recruiting - Microbiome Clinical Trials

Microecology and Immunity in Patients With Anti-MDA5 Antibody Positive Dermatomyositis and Interstitial Lung Disease

Start date: January 20, 2024
Phase:
Study type: Observational

The purpose of this study was to analyze the relationship between the microbial community, host immunity and the presence or absence of concurrent rapidly progressive interstitial lung disease patients with anti-MDA5 antibody positive dermatomyositis.

NCT ID: NCT06133400 Completed - Microbiome Clinical Trials

Mapping the Health Status of the Population of French Polynesia: the MATAEA Project

MATAEA
Start date: November 4, 2019
Phase: N/A
Study type: Interventional

This is a cross-sectional study carried out on a sample of the adult population aged 18 to 69, distributed over the five archipelagos of French Polynesia. Participation in the study involves: agreement to answer a questionnaire to collect information on socio-demographic characteristics, lifestyle habits and medical history; physical measurements (height, weight, waist circumference, blood pressure and skin pigmentation); and agreement to take biological samples (blood, saliva and stool) for biological, genetic and microbiological analyses. The aim of the study is to assess the current health status of the population of French Polynesia and to evaluate the influence of contextual risk factors (lifestyle, place of residence, history of infection) and intrinsic susceptibility factors (genetics, age, gender, microbiota) in relation to non-communicable and infectious diseases.

NCT ID: NCT05852145 Not yet recruiting - Dental Plaque Clinical Trials

Oral Changes With Caloric and no Caloric Sweeteners

Start date: October 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this clinical trial is to compare the effect that the intake of beverages without sweetwners, added with non-caloric sweeteners (stevioside) and caloric sweeteners (sucrose) on oral pH and dental biofilm microbiome in Mexican adolescents. Participants will drink on different occasions a beverage without sweetener, a beverage added with stevioside or a beverage added with sucrose. The researchers will compare the changes that each one causes in salivary pH, dental biofilm pH, dental biofilm bacterial proliferation and dental biofilm microbiome.

NCT ID: NCT05821010 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis

SYNCH
Start date: March 17, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation capsules to reduce NASH in patients with fibrotic NASH. The main questions to answer are: 1. Can NASH be treated by altering the gut microbiota using LFMT capsules? 2. Can NASH be treated using a syntrophic cocktail of synbiotics and will these strains strengthen the effect of FMT? 3. What are the underlying mechanism by which the aforementioned treatments attenuate NASH? Participants will be treated with FMT-capsules or placebo, and all participants will receive a cocktail of 3 strains of probiotics and one type of prebiotic.

NCT ID: NCT05738460 Active, not recruiting - Healthy Clinical Trials

Effects of IAP-EOGBSD on Offspring's Gut Microbiome and Immunity.

Start date: February 23, 2022
Phase:
Study type: Observational

This study is planned to be recruited in two hospitals in South China, Zhujiang Hospital of Southern Medical University and Zhongshan Boai Hospital Recruit participants, plan to recruit obstetrics and child health departments in study hospitals, meet inclusion and discharge criteria 1~3 infants, a total of 360, recruited by Pearl River Hospital of Southern Medical University and Zhongshan Boai Hospital 180 people each.

NCT ID: NCT05612620 Not yet recruiting - Microbiome Clinical Trials

Elucidating the Microbiome in Patients With Recurrent Pregnancy Loss

Start date: November 14, 2022
Phase:
Study type: Observational [Patient Registry]

Recurrent pregnancy loss (RPL) is defined as 2 or more consecutive miscarriages1 This condition affects about 1-3% of couples during their reproductive years. The role of vaginal infections in RPL is controversial and microbiological screening is not recommended as per the international guidelines. Current theories suggest that altered vaginal and uterine microbiota may trigger an inflammatory response in the endometrium even without the presence of clinical infection which could affect the success of embryo implantation and future development of pregnancy2 .Changes in the uterine microbiota can lead to chronic endometritis (CE). This condition is caused by continuing inflammation of the endometrium, involving a variety of common bacterial and yeast species and has been associated with RPL3 . Notably, CE can be found in up to 45% of infertile patients4. Current diagnosis of CE is based on histopathological examination, immunohistochemistry assay for CD138 cells and morphological appearance on hysteroscopy. While antibiotic treatment can improve ongoing pregnancy rates in patients with RPL treatment success is still partial and unpredictable. A mechanistic link is yet to be established between vaginal and uterine microbiota and RPL and it is unknown whether restoration of the microbiome in patients with RPL can improve pregnancy outcomes.

NCT ID: NCT05598489 Recruiting - Ulcerative Colitis Clinical Trials

Development of Novel Fecal Microbial Biomarkers for Inflammatory Bowel Disease

Start date: December 7, 2022
Phase:
Study type: Observational

Inflammatory bowel disease (IBD), including Crohn's disease (CD) and Ulcerative colitis (UC), is a chronic idiopathic inflammatory condition of the intestine. Endoscopy has been used to monitor the disease, but it is time-consuming, costly, invasive, and associated with certain risks of morbidity. Many patients are reluctant to undergo repeated endoscopic examinations, particularly when their disease is quiescent. Acute phase reactants have been used to monitor disease including C-reactive protein and stool leucocyte markers including fecal calprotectin, but their sensitivity and specificity in correlating to intestinal inflammation activity are low. Clinical challenge of patient heterogeneity in disease phenotype and response to therapy has compounded discovery of disease-related biomarkers. In IBD, altered fecal microbiota signatures have been consistently reported which included a reduction in biodiversity with lower proportions of Firmicutes and increases in Proteobacteria and Bacteroidetes phylum members. Moreover, overall bacterial diversity is consistently decreased in IBD patients compared to controls. Even though a number of fecal biomarkers have been evaluated for their utility for disease diagnosis in IBD, to date none has been accurate enough for clinical application. Therefore, identification and validation of a non-invasive biomarker which can be easily applied in disease diagnosis and prognosis is warranted to provide an earlier opportunity to intervene. In this study, it aims to develop a metagenomics-based model using fecal microbial biomarkers for differentiating IBD patients from healthy controls, and then validate these fecal microbial biomarkers in different populations.

NCT ID: NCT05545631 Recruiting - Infertility Clinical Trials

Frozen Embryo Transfer Pregnancy Outcomes Prediction by Microbiome and Transcriptome

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

This study intends to explore the correlation between cervical microbiome, gut microbiome, transcriptome and pregnancy outcomes of frozen embryo transfer patients through a multicenter prospective observational study, and to explore the predictive value of microbiome on pregnancy outcome.