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Microbiota clinical trials

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NCT ID: NCT06241222 Completed - Microbiota Clinical Trials

Origin of the Neonatal Gut Microbiota and Probiotic Intervention

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

This study aim to evaluate the origin of the neonatal gut microbiota in 14th days and Probiotic intervention. Samples were obtained from a total of 30 pregnant individuals and their offspring, divided into control group and porbiotics group, analyzing by 16S rRNA amplicon sequencing of the V4 region to evaluate the composition of them. Multiple linear regression were used to evaluate the origin of neonatal gut microbiota.

NCT ID: NCT05974124 Completed - Microbiota Clinical Trials

Effectiveness of Ophthalmic Antiseptic Preparations

Start date: November 9, 2022
Phase: N/A
Study type: Interventional

The aim of this clinical trial is to evaluate the effectiveness of two topical antiseptics, povidone-iodine (PVI) and chlorhexidine (CHX), in reducing conjunctival bacterial flora.

NCT ID: NCT05941663 Completed - Microbiota Clinical Trials

Microbiome Development in the Early Healing of Osseointegrated Implants

PiMicrobiome
Start date: January 28, 2023
Phase: N/A
Study type: Interventional

The aim is to compare the microbiome composition on the first month of healing and 2 years after rehabilitation in two different implant surfaces (SLA® vs SLActive®). Subjects in need of two or more dental implants (canine to molars) in two different quadrants will be included so that, one study test (SLActive®) and one study control (SLA®) implant will be placed in different quadrants in healed extraction sites. Gingival crevicular fluid (GCF) samples will be taken for microbiome analysis at different time points. Samples will be processed using high throughput sequencing technologies (Illumina® MiSeq) and the raw sequencing reads will be processed with the Quantitative Insights Into Microbial Ecology (QIIME2) pipeline. DADA2 will be used for quality trimming and inferring amplicon sequence variants (ASVs). Taxonomy will be assigned to ASVs using the Naive Bayesian Classifier integrated in QIIME2 plugins and the eHOMD RefSeq database. Alpha-diversity and Beta diversity will be calculated and measured. Differences in bacterial abundance will be analyzed using linear models for differential abundance analysis (LinDA). This is the long-term follow-up of the randomized clinical trial entitled "Randomized controlled study to evaluate the clinical behavior of dental implants with SLActive® surface vs. SLA® surface" Promoter Code: CR 2017-05, Internal Code: 18/580-R_P, Promoter: Institute Straumann AG. In this new protocol, the participants included in the clinical trial at the Complutense University of Madrid will be selected, who will undergo a new follow-up visit at 2 years, to measure the clinical, radiographic and microbiological situation. periodontal treatment without any additional intervention. In addition, it is intended to analyze the microbiome of the samples of gingival crevicular fluid that we have frozen from the patients of the UCM, as well as of the samples that are taken after two years. All these changes are promoted by our ETEP (Etiology and Therapeutics of Periodontal and Peri-implant Diseases) research group, independently of the original sponsor of the study.

NCT ID: NCT05864352 Completed - Inflammation Clinical Trials

The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health

Start date: September 22, 2021
Phase:
Study type: Observational

This proposal will quantify dietary exposure of a nano- food additive in the U.S. food supply, and determine its impact on the human gut microbiome, gut inflammation, permeability and oxidative stress. Titanium dioxide (TiO2, or E171 food grade additive) is used in processed foods, with thousands of tons produced annually and an expected increase >8.9% from 2016 to 2025. Preclinical models demonstrate >99% of consumed TiO2 is retained within the intestinal lumen and excreted in the feces. In animal models, dietary TiO2 causes shifts in the gut microbiome, decreases acetate production, increases biofilm formation, and causes profound disruption of gut homeostasis and intestinal tight junctions, due to the production of reactive oxygen species and increased inflammation. However, the relation between chronic TiO2 intake and human gut homeostasis has yet to be elucidated. France issued an executive order to ban food grade TiO2 use after January 1st 2020, over serious safety concerns. Since then, multiple European civil societies have jointly called for an executive order to ban TiO2 across the EU. Typical TiO2 intake among U.S. adults remains to be documented, and there are no known studies that estimate dietary exposure of TiO2 using a whole foods approach. Therefore, the overarching goals of this project are to: 1) measure dietary TiO2 exposure in a sample of U.S. adults, using dietary recalls and fecal TiO2 content; 2) determine how fecal TiO2 content is related to gut dysbiosis, metatranscriptomics, intestinal inflammation, permeability and oxidative stress.

NCT ID: NCT05726435 Completed - Microbiota Clinical Trials

Effects of Soluble Dietary Fiber on Sport Efficiency and Fatigue Delay in Top Basketball Players

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

Athlete nutrition is becoming an increasingly important factor on the path to achieving top results. Nutrients such as soluble fiber can alter the intestinal microbiota, resulting in metabolites with a positive effect on metabolism. Thus, the fibers become available, an additional source of energy to the host, have an anti-stress effect and delay the feeling of fatigue. The primary goal of the study is to determine the impact of soluble dietary fiber on increasing athletic efficiency, the secondary goal is to determine the impact of fiber on delaying fatigue. Subjects will be randomly divided into experimental and control group. The sample of variables will consist of genome microbiota genome sequencing data, measures to assess morphological characteristics, lower extremity explosive strength tests, and cardiovascular endurance. The statistical package SPSS will be used for data processing. The expected scientific contribution of this research is to expand the scientific knowledge about the importance of dietary fiber in the diet of athletes with the aim of improving sports performance.

NCT ID: NCT05674318 Completed - Microbiota Clinical Trials

The Effect of Alpha-lactalbumin on Microbiota Composition

Start date: January 30, 2023
Phase: N/A
Study type: Interventional

To evaluate the effects on microbiota composition after the administration of an oral supplementation based on Alpha-lactalbumin in subjects with dysbiosis.

NCT ID: NCT05614726 Completed - Constipation Clinical Trials

A Probiotic Blend Reduces Gastrointestinal Symptoms and Positively Impacts Microbiota Modulation in a Randomized Study

Start date: June 18, 2021
Phase: N/A
Study type: Interventional

This randomized, placebo-controlled, double-blind study will determine the effect of daily supplementation with a probiotic blend in 60 apparently healthy men and women recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences). Subjects will attend three study visits. During Visit 1, subjects will be screened for participation [i.e., medical history, routine blood work, background baseline diet]. During Visits 2 and 3 subjects will complete questionnaires that assess their gastrointestinal health (e.g., abdominal discomfort/bloating, constipation, regularity, stool consistency). Visits 2 and 3 will correspond to before (week 0) and after six weeks of supplementation, respectively, with the probiotic dietary supplement or placebo.

NCT ID: NCT05451992 Completed - Clinical trials for Overweight and Obesity

Microbiome-Tailored Food Products Based On Typical Mediterranean Diet Components

SUPERFOOD 19-2
Start date: February 15, 2021
Phase: N/A
Study type: Interventional

The composition and functions of the microbiome impact human metabolism and health status. Diet plays a fundamental role in shaping the structure of the gut microbiome, modulating the interaction between the gut microbiome and the human host. Western dietary patterns including a high consumption of red and processed meat, refined grains and sugars, and dairy products have been associated with a high incidence of chronic diseases. It is widely recognised that there is a higher consumption of plant-based foods in Mediterranean countries than in other Western countries. The Mediterranean diet involves a high intake of fruits, vegetables, legumes, nuts, minimally processed cereals, moderate consumption of fish and a low consumption of saturated fats, meat and dairy products with regular intake of extra virgin olive oil. The Mediterranean diet reduces the incidence of cardiovascular, metabolic and neurodegenerative diseases. Interesting results emerged from the evaluation of the microbiome-metabolome interaction, which shows that individuals with the highest adherence to the Mediterranean diet had much higher levels of short-chain fatty acids (SCFAs) and increased levels of the beneficial fiber-degrading bacteria compared to subjects with low adherence to the Mediterranean diet. The study of the effect on the microbiota of specific foods with anti-inflammatory/antioxidant properties is interesting and of potential clinical impact.

NCT ID: NCT05394948 Completed - Overweight Clinical Trials

Circular Economy and the Design of Healthy and Sustainable Food and Ingredients

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

There is a need to change eating patterns towards healthier diets with new sources of non-animal protein, obtained through more sustainable systems in line with strategies such as the European Green Deal, the "Farm to Fork" strategy, or the Common Agricultural Policy, among others. The objective of this study, is to evaluate the nutritional effect of the developed products and their impact on the improvement and/or prevention of health problems (diabetes, intestinal dysbiosis), as well as to design and evaluation of the effect on health of a vegetable protein-based nutraceutical that also includes fiber and resistant starch.

NCT ID: NCT05352724 Completed - Microbiota Clinical Trials

Clinical Trial to Evaluate the Efficacy of a Sport Drink After High-intensity Aerobic Exercise

Start date: October 20, 2022
Phase: N/A
Study type: Interventional

Although the general effectiveness of carbohydrate/electrolyte-based functional sports drinks on rehydration, recovery and sports performance has been widely demonstrated, there is controversy about the amounts, proportions and components that ensure the effectiveness of these products. The present study intends to analyze the specific effects of the beverages to be studied on these parameters, taking into account their particular formulation. Advances in research have allowed us to understand the importance of the intestinal microbiota on health, recovery and performance in sports. The consumption of functional drinks based on carbohydrates and electrolytes as supplementation is a constant in sports environments, with multiple studies on their properties, tolerance, safety and efficacy. However, there are no studies that analyze the effects of consuming these beverages and their interaction with the intestinal microbiota. Therefore, in addition, it is intended to evaluate the changes in the microbiota, through analysis of stool samples, during the sustained consumption of the beverages under study.