65 Clinical Trials for Various Conditions
The purpose of this study is to advance our knowledge of the factors that contribute to the development of bronchopulmonary dysplasia (BPD), a chronic lung affecting premature infants. Specifically, the investigators will determine the complexity of the gut microbiota, the genera of the bacteria that naturally live in the gut, and determine if the relative diversity of the gut bacteria is a prognostic indicator of BPD. To accomplish this, the investigators propose to characterize the microbiota of human premature newborns with BPD, then validate this potential mechanism in mice. The investigators will enroll very low birthweight premature infants admitted to the neonatal intensive care units (NICU) at Le Bonheur Children's Hospital and Regional One Health that are at high risk to develop BPD. A cohort of well full term newborns will also be enrolled. Non-invasive stool samples will be obtained weekly over the first month of life. Infants that eventually develop BPD will be paired with infants that did not develop BPD. Stool samples from these infants will be sent for analysis. The investigators expect that reduced complexity of the gut microbiome is associated with BPD. The investigators will model the contribution of reduced microbiome complexity to the risk to develop BPD or death, as well as the association with disease severity. The project investigates important factors leading to the development of BPD, and has the potential to directly translate to therapy for the most significant pulmonary complication of prematurity.
This study analyzes the gastrointestinal microbiome of appendiceal cancer patients with peritoneal spread scheduled to undergo cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC). Participants will provide fecal samples pre- and post-operatively.
This study aims to investigate the effect of a cobiotic formulation, prepared as a smoothie beverage, on the ratio of intestinal microbiota of the Bacteroidetes phylum to those of the Firmicutes phylum in the stool as well as the effect on insulin resistance, gut hormones (PYY) Peptide YY and (GLP-1) Glucagon-like Peptide, ghrelin with perceptions of appetite and satiety.
This study is a randomized, double-blind, placebo-controlled study of N=40 adult men and women with occasional GI issues. This study to assess the effect of a novel dietary supplement on the gut microbiome, nutrient gaps, and tolerability.
This study is a randomized, double-blind, placebo-controlled study of N=20 active men and women. This study to assess the effect of a novel dietary supplement on improving nutrient gaps and the gut microbiome.
This study is a randomized, double-blind, placebo-controlled study of N=30 apparently healthy men and women. This is an exploratory study to assess the effect of a novel dietary supplement on blood markers of nutrient status and the gut microbiome.
The gut microbiome refers to the trillions of bacteria that inhabit the stomach and other regions involved in the digestion of food, including the intestines. Compelling studies of animals (rodents) suggest that the health of the gut microbiome may influence skeletal muscle function and exercise performance. To date, there have been no similar observations reported in humans. A common experimental approach in animal studies to temporarily disrupt the gut microbiome is through the use of antibiotic therapies. Azithromycin is an antibiotic medicine prescribed to humans for the treatment of mild to moderate infections caused by bacteria. The purpose of the proposed project is to determine the influence of short-term (5-days) antibiotic therapy (azithromycin) on exercise performance in young, healthy adults. Treadmill exercise performance will be compared in two groups of adults before and after 5-days ingestion of azithromycin, or a placebo (something that has no physical effect).
This clinical trial will compare stool and oral microbiome composition between infants fed breast milk or one of two infant formulas for a 60 day feeding period.
This is a pilot feasibility study designed to investigate the alterations in the gut microbiome that occur during the course of treatment for colorectal cancer
This is an ancillary study to KIDFIT (NCT03405246). KIDFIT tests whether preschool-age children, born to overweight or obese mothers, respond to a healthy DASH diet intervention with better cardiovascular health. This ancillary study to KIDFIT investigates how the children's gut microbiomes (bacteria in the intestines) and blood metabolomes (small molecules in the blood) are affected by the DASH diet intervention, and how the microbiome and metabolome relate to the children's cardiovascular health over time. The investigators hypothesize that (1) the DASH diet will modify the gut microbiome and blood metabolome, (2) the gut microbiome and blood metabolome will be related to each other, and (3) the microbiome and metabolome will be associated with the children's cardiovascular health profiles (things like weight, body fat, blood pressure, and cholesterol).
The purpose of this study is to evaluate whether oral HA35 supplementation changes the normal intestinal bacteria, increases intestinal protection, decrease intestinal inflammation and permeability, and to assess any health benefits and confirm the safety profile of HA35.
The purpose of this study is to evaluate the ability of a wearable Smart Underwear prototype device to quantify diet-induced changes in gut microbial hydrogen sulfide (H₂S) production. The core design is a single-site, 2-period, crossover feeding study with 6-day diet periods and an approximately 11-day washout period. Participants are fed each of two isocaloric diets designed to contrast gut microbial H₂S production (i.e., a high cysteine vs. low cysteine diet), in a random order.
This study is a randomized, double-blind, placebo-controlled study of N=120 apparently healthy men and women. The purpose of this study is to assess the effect of a novel dietary supplement on blood markers of nutrient status, gut microbiome, and overall quality of life.
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance.
This is research study is assessing the effects of 6-g daily use of freeze-dried instant coffee on liver fat and fibrosis and the gut microbiome and metabolome in patients who have completed routine treatment (including surgery, chemotherapy and radiotherapy) for stage I-III colorectal cancer.
Aim: To test the effects of a fiber-blend containing snack prototype in an escalating dose regimen (from 1 to 3 servings per day over a period of 6 weeks) on the configuration and gene content of the gut microbiota of overweight and obese participants (BMI 25-35 kg/m2), while consuming a controlled diet that contains quantities of saturated fats in the upper tertile and quantities of fruits and vegetables in the lower tertile of consumption in the NHANES database (high saturated fat-low fruit and vegetable; HiSF-LoFV). Changes in the representation of bacterial genes involved in carbohydrate utilization in the microbiomes of participants will be correlated with changes in plasma biomarkers at the end of each escalating dose phase by comparing features of their pre- vs post-treatment plasma proteomes and metabolomes. Design: Participants will be asked to continue to consume their habitual diet (free diet phase) for 1 day prior to being provided with a HiSF-LoFV diet in the form of packed-out meals and snacks to consume for the following 62 days. Ten days after starting to consume the HiSF-LoFV diet, participants will supplement this diet with a fiber-blend containing snack (\~10g fiber/serving) once daily for a total of 14 days; the energy contribution from the HiSF-LoFV diet will be reduced accordingly to maintain energy needs during this time and the remainder of the study. For the next 14 days, the diet will be supplemented with two of the same fiber-blend containing snacks per day, followed by 14 days in which the snacks will be consumed three times daily. Subsequently, a 'wash-out' phase of ten days in which the HiSF-LoFV diet is consumed without any of fiber snack supplementation will conclude the study. Stool, urine and blood will be sampled periodically throughout.
This study seeks to determine whether the virus which causes COVID-19, SARS-CoV-2, is shed in the stools of patients who are infected.
This research study is evaluating the effect of AMR101 as a possible chemopreventive agent to reduce risk of colorectal cancer in individuals with a history of colorectal adenoma. - The name of the study drug involved in this study is: -- AMR101 (VASCEPA).
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records.
This proposal will examine whether daily consumption of fermented vegetables for 6 weeks can impact the gut microflora and markers of inflammation of women between the ages of 18-70 years.
Neonates delivered by scheduled Cesarean Section will be randomized to receive vaginal seeding (exposing the infant to Mother's vaginal flora) or sham. Infants will be followed for three years to examine health outcomes including microbiome development, immune development, metabolic outcomes, and any adverse events.
The goal of this clinical trial is to learn about the effects of avocado consumption on gastrointestinal health in adults with overweight and obesity. The main questions is aims to answer are: How does avocado consumption affect the gut microbiome? How does avocado consumption affect thinking? Are there connections between the microbiome and cognition? Participants will be asked to eat provided meals with and without avocados for three 4-week periods. At the end of each 4-week period, participants will be asked to provide stool samples and complete computer games that assess thinking and memory.
Gulf War Illness (GWI) affects an estimated 25-32% of the over 700,000 coalition troops deployed to the Persian Gulf as part of the First Gulf War. GWI causes a range of pain, fatigue, gastrointestinal, skin, neurologic, and respiratory symptoms. New treatments to reduce GWI-associated morbidity are critically needed. Research suggests a role for the gastrointestinal microbiome in mediating health, including through impacting metabolism and immunity. The disruption of this microbiome plays a role in multiple diseases, and preliminary data suggest that Veterans with GWI have altered gut microbiota. The investigators will evaluate the effectiveness of a dietary fiber prebiotic supplement intervention on improving the quality of life of Veterans with GWI.
The purpose of this study is to learn more about what happens in the human body after consuming a meal that contains ultra-processed foods like hamburgers, and if this is different to what happens after consuming a meal that contains lots of whole foods, like fresh vegetables, instead.
This study evaluates the effects of either Pediasure or Nourish formulas on the gastrointestinal microbiome in critically-ill children. Patients will be randomized to received either Pediasure or Nourish.
The investigators are interested in learning more about choline, a nutrient required by the body. The body does make some choline, but it does not make enough to support health and the rest must be acquired through diet. Eggs, and especially egg yolks, are a major dietary source of choline. Choline can also be given as a dietary supplement. Ingestion of choline supplements has been linked to an increased concentration of a compound called TMAO (trimethylamine N-oxide). Elevated TMAO levels have been linked to higher heart disease risk. With this study, the investigators hope to learn whether there is a difference in the way your body responds to the ingestion of a choline supplement versus the choline found within eggs.
A randomized pilot trial of a probiotic for quality of life in autism spectrum disorder (ASD), targeting gastrointestinal (GI) symptoms.
The purpose of this research is to test whether bacteria that normally live in the intestines play a role in fighting cancer. It is believed that the development and behavior of these immune cells may be influenced by bacteria and other microorganisms living in the gut. In turn, the activities of these immune cells could work with anti-cancer therapies to make them more, or less, effective.
The purpose of this study is to compare the Pediatric Quality of Life Inventory Gastrointestinal Symptoms Scale Gastrointestinal Symptoms Scale (GI-PedsQL) differences , to assess the differences in stool microbiome and stool metabolomics , to assess differences in salivary cytokine profile , to assess differences in weight change , to compare the use of antacid medications and to compare the use of laxative medications in patients on commercial formulas (CF) versus commercial blenderized tube feed (CBTF).
The purpose of this study is to compare the effects of PROMITOR® Soluble Corn Fiber versus inulin on GI symptoms (tolerance), stool consistency (laxation) and fecal microbiome at levels that could contribute to closing the fiber gap. The dose response effects of PROMITOR® Soluble Corn Fiber in healthy children will also be compared.