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Microbiota clinical trials

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NCT ID: NCT05891977 Recruiting - Cognitive Function Clinical Trials

Effect of Tomato Paste Consumption on the Microbiota-gut-brain Axis in Healthy Adults

MITOS
Start date: October 26, 2023
Phase: N/A
Study type: Interventional

Tomatoes and tomato-based products could play an important role in modulating microbiota-gut-brain axis (MGBA) interactions due to their high content of fiber and phytochemicals. Phytochemical metabolites derived from the consumption of tomato-based products can act directly as neurotransmitters in the central nervous system, crossing the blood-brain barrier, or indirectly by modulating the MGBA. These metabolites can thus alter gut bacterial composition and brain biochemistry. Therefore, researchers propose a new interventional study to assess the impact of daily tomato consumption in the organism, and to evaluate the effect on the MGBA. The final aim of this study is to spread a message of the health benefits of tomato consumption for the general population.

NCT ID: NCT05864352 Active, not recruiting - 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: NCT05830591 Recruiting - Clinical trials for Autism Spectrum Disorder

Gut-oral Axis Microbiome in Autism Spectrum Disorders

Start date: May 20, 2021
Phase:
Study type: Observational

Autism Spectrum Disorder (ASD) is a neurodevelopment disorder characterized by impairment in social interaction, communication, and behavior, as well as sensory challenges. In addition, secondary symptoms can appear, such as gastrointestinal disorders. Gut microbiota has an important role in the harvest of nutrients and energy from our diet. It influences a wide range of metabolic, developmental, and physiological processes such as the maintenance of the gut epithelial layer, immune system development, protection against pathogens, detoxification and xenobiotics degradation. The ecosystem of a healthy human gastrointestinal (GI) tract is mainly populated by Firmicutes and Bacteroidetes phyla, to a lesser extent by Actinobacteria and Proteobacteria, in this case the microbiota is in an eubiosis condition. Whether a disturbance of the microbial ecosystem occurs, gut microbiota is in a dysbiosis condition and it could lead different metabolic disorders. The two-way communication between gut microbiota and central nervous system (CNS) affects stress response, pain perception, neurochemistry and several disorders. The gut microbiota in ASD patients revealed some peculiarities such as the high percentage of Propionibacter and Clostridium, well known for their production of pro inflammatory metabolites, or an increment of Sutterella spp. and Ruminococcus torques, which are negatively associated with the health of the gut. Recent studies suggest that also the oral microbiota may be involved in ASD symptoms assuming the existence of a "microbiota-oral-brain axis". ASD patients are often suffering of several oral cavity disorders like caries, gingivitis and periodontitis, probably due to the poor oral hygiene. These disorders are linked to a dysbiosis of the oral microbiota: the characterization of the ASD subjects oral microbiota showed a lower biodiversity of bacteria species and different levels of specific bacteria, comparing to the controls. Several studies suggest that some bacteria species invade the blood-brain barriers as well as their metabolites, triggering inflammatory response and an alteration of the metabolic activity in the CNS. It has been demonstrated that ASD patients have a high level of pro-inflammatory cytokines and chemokines in the cerebrospinal fluid and an upregulation of the microglia. The oral microbiota could also affect the lower GI tract and have a significant role within the ASD-associated GI disorders and CNS inflammation

NCT ID: NCT05797207 Recruiting - Clinical trials for Inflammatory Bowel Diseases

Evaluation of the Diagnostic Potential of Artificial Intelligence-assisted Fecal Microbiome Testing for Inflammatory Bowel Disease

Start date: April 10, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the diagnostic potential of Artificial Intelligence-assisted Fecal Microbiome Testing for the diagnosis of inflammatory bowel disease. The main question it aims to answer is: • Is Artificial Intelligence-assisted Fecal Microbiome Testing a reliable screening test for inflammatory bowel disease? Participants will be asked to provide fecal samples to be analyzed with next-generation sequencing techniques. If there is a comparison group: Researchers will compare the diagnostic performance of AI-assisted Fecal Microbiome Testing with colonoscopy to see the correlation between the results of both interventions.

NCT ID: NCT05795725 Recruiting - Colon Cancer Clinical Trials

Evaluation of the Diagnostic Potential of Artificial Intelligence-assisted Fecal Microbiome Testing for Colon Cancer

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

The goal of this clinical trial is to evaluate the diagnostic potential of Artificial Intelligence-assisted Fecal Microbiome Testing for the diagnosis of colon cancer. The main question it aims to answer is: • Is Artificial Intelligence-assisted Fecal Microbiome Testing a reliable screening test for colon cancer? Participants will be asked to provide fecal samples to be analyzed with next-generation sequencing techniques. If there is a comparison group: Researchers will compare the diagnostic performance of AI-assisted Fecal Microbiome Testing with colonoscopy to see the correlation between the results of both interventions.

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: NCT05681208 Not yet recruiting - Microbiota Clinical Trials

Microbiota Awareness and Nutrition Education Given to Mothers With Motivational Interview

Start date: January 25, 2023
Phase: N/A
Study type: Interventional

Complementary nutrition is considered a critical step not only for changes in nutritional requirements but also for the formation of life-long taste preferences, nutrition and eating habits that may affect health in the long run. While the microbiota is developing, in the early stages of life, the wrong food choice negatively affects the microbiota development and causes malnutrition. In this study, the effect of motivational interviews prepared according to the Health Behavior Interaction Model on microbiota awareness and infant feeding attitude will be investigated in primiparous mothers who will start complementary feeding.

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: NCT05606523 Recruiting - Pancreatic Cancer Clinical Trials

Microbiota and Pancreatic Cancer Cachexia

EXTRA
Start date: August 1, 2022
Phase:
Study type: Observational

This monocentric study aims at evaluating the effects of fecal microbiota transplantation from newly diagnosed cachectic and non-cachectic pancreatic cancer patients, and healthy volunteers on several cachexia-related parameters of germ-free mice.