187 Clinical Trials for Various Conditions
Beans are well known for their health benefits. Many of these benefits relate to gut health, as many of the nutrients found in beans support beneficial microbes that live in the gut. However, beans have a lot of genetic diversity. This diversity has led to different bean market classes with different colors, sizes, and nutrient profiles. Differences between bean market classes may trigger different effects on gut microbes and health, but this is poorly understood. The goal of the pilot clinical trial is to make comparisons (1) between two different bean market classes (pink beans, great northern beans) and (2) between a bean mixture (pinto, kidney, black, pink, and great northern beans) and individual bean market classes. The study will assess whether bean market classes differ in their effects on gut microbes, blood pressure, metabolism, and gut symptoms in adults with and without obesity.
The purpose of this study was to identify specific microbes that change with supplementation with galactooligosaccharides-prebiotics that are associated with alleviation of lactose intolerance symptoms in lactose-intolerant human subjects.
Background: Human intestines are home to a complex gut flora, also called microbiome; this is a natural occurring community of bacteria, fungi, yeast, and viruses. Changes in the balances of the gut flora can lead to illnesses, such as diabetes, colorectal cancer, and inflammatory bowel diseases. Synbiotics are dietary supplements people take to maintain proper balances of their gut flora aiming to improve health. Objective: To find out if a synbiotic supplement can increase the type and amount of beneficial gut bacteria in healthy people as well as improve cardio-vascular protection markers. The supplement contains a natural sugar from human milk. Eligibility: Healthy people aged 18 years or older who eat a typical western diet. They must take no medications (with a few exceptions). Design: Participants will have 2 clinic visits. The first visit will start with screening. They will have a blood test and wait around 2 hours for the results of the blood test. The test will determine if they are eligible for the study. Eligible participants will have additional blood drawn during the screening visit. They will be given a kit to collect a stool sample at home with instructions. They may complete a 3-day food diary. They will meet with a nutritionist and a physician by phone, telehealth, or in person. The supplement is a powder that is mixed with water or another noncarbonated drink. Participants will drink 2 doses per day. Each dose will be 1 hour before or after a meal. The second visit will be about 8 weeks after the first. Participants may repeat the 3-day food diary and nutrition visit. The physical exam, blood tests, and stool sample will be repeated.
According to International Scientific Association for Probiotics and Prebiotics (ISAPP), a prebiotic is defined as a substrate that is selectively utilized by host microorganisms conferring a health benefit (Gibson et al, 2017). Fibers/ Prebiotics are known to have several beneficial effects on human health via gut. They remain mostly undigested in upper GI and reach colon where they are fermented by resident gut microbiota. This leads to the production of several beneficial metabolites such as short chain fatty acids and others which are implied in human health. The aim of this study is to examine the effects of combinations of two prebiotics on gut microbiota modulation and Quality of Life at two doses.
The gut microbiome is made up of the microbes (such as bacteria, viruses, and other organisms too small to see with the naked eye) that live in the digestive tract and has been shown to be important in metabolizing food, extracting vitamins and nutrients from food, and maintaining a healthy gut lining. The gut microbiome plays an important role in overall health and has been shown to dynamically change in response to early-stage triple-negative breast cancer-directed therapies, which in turn has been associated with worse outcomes. As the gut microbiome can be further modulated with dietary changes during cancer treatment, it is an ideal potential modifiable risk factor in cancer patients. However, due to multiple confounding factors such as dietary intake, mood, and activity, its utility as part of the oncologic clinical assessment remains unclear. In this prospective randomized controlled study, the investigators propose to recruit up to 30 early-stage TNBC patients to randomize to a personalized nutritional intervention of a high-fiber diet coached by a registered dietician versus educational handout alone during neoadjuvant treatment. The investigators propose to study the gut microbiota through stool sample analysis among early-stage triple-negative breast cancer patients undergoing neoadjuvant (i.e. before surgery) chemotherapy +/- immunotherapy. The investigators will also study how the gut microbiota can be further modulated with a high-fiber diet, and the investigators hypothesize that a high-fiber diet may play a protective role in preserving gut microbial diversity. As part of the nutritional intervention, the investigators propose to administer nutritional counseling with a registered dietitian (RD) to increase fiber intake and tracking performance status, activity, and mood during neoadjuvant treatment. Finally, the investigators propose to survey participants after study completion through one-on-one interviews to determine whether participants experienced improved overall patient satisfaction in supportive care during their treatment.
Polyphenol-rich Haskap berries (Haskap) have untapped therapeutic potential to improve human health, and agricultural producers in northern U.S. states are poised to increase production if consumer demand increases. A critical knowledge gap is that little is known about the interactions between gut microbes and Haskap polyphenols to produce bioactive metabolites linked to downstream health impacts. Additionally, little is known about which Haskap varieties and harvest timing yield the greatest bioactive potential. This study aims to address these gaps by investigating the interaction of bioactive components in Haskap with gut microbiota and the resultant gut and serum metabolites, inflammation, and metabolic health, and then couple this with analysis of berries from different Haskap varieties and harvest times.
Accordingly, the purpose of this study is to evaluate the efficacy of 1) supplementation with Synbiotic (Plexus® Triplex), 2) commercially-available Probiotic, or 3) placebo control over 30 days on the gut microbiome, cardiometabolic health, body weight and body composition in healthy individuals.
The main aim of this study is to investigate differences in rate, extent of change and persistence of the gut microbiota in healthy adult volunteers in response to native chicory inulin. Along with investigating the impact of native chicory on bowl habits, mood and appetite. The two main questions this study aims to answer: * To what extent do differences exist in rate of change over time between individuals in gut microbiota response (Bifidobacterium growth) to native chicory inulin supplementation. * To what extent do differences exist between individuals in persistence of the gut microbiota upon stopping supplementation. The effects of native chicory inulin on gut microbiota response will be compared to a maltodextrin placebo to sure changes in gut microbiota result directly from chicory inulin supplementation. Participants will firstly complete a one-week run-in phase to establish baseline data and will then be allocated to either native chicory inulin or maltodextrin supplementation for 6 weeks. Inulin will be delivered at 12 g/day split into 2 x 6g portions. Maltodextrin will be calorie matched at 6 g/day split into 2 x 3g portions. This will then be followed by a 6 week post-supplementation phase. Fecal and blood samples will be collected regularly throughout all phases for analysis of gut microbiota and compounds of interest. Participants will also record any changes in gastrointestinal sensation, bowel habits and mood in a diary. Changes in appetite sensation will also measured.
This is a single-center, open-label study for safety and feasibility of IMT in patients undergoing colonic surgery. After consent, individuals of the ages of 18-75 with a history of diverticulitis or sigmoid colon cancer will be enrolled to have a feeding tube placed at the time of surgery and receive IMT solution on postoperative day 2-3 (at least 48 hours following IV antibiotics) with the subsequent removal of the feeding tube. Prior to administration of IMT, recipients will be screened for inclusion/exclusion criteria, interviewed for medical history and medications, and consented. Additionally, prior to undergoing IMT, baseline blood and fecal samples will be collected. The use of a nasogastric feeding tube has specifically been chosen over colonoscopic introduction of the IMT. This is because colonoscopy introduces increased intraluminal carbon dioxide and pressure as well as mechanical stress on the colon in the setting of a newly created bowel anastomosis, which may contribute to the potential risk of anastomotic disruption. The nasogastric feeding tube will be placed while the patient is under anesthesia under direct visualization to minimize any risk of bowel perforation, albeit very low. The study will specifically utilize a 10F 43" Corpak feeding tube (Halyard Health, Alpharetta, GA). Patients will be monitored while in-patient in person. Following discharge, they will undergo follow-up either by phone, video or in-person visit, or via online survey of symptoms and chronic medical conditions potentially related to IMT, beginning on the day following discharge through post-operative day 14, and then monthly up to 6 months post- IMT to screen for SAEs and AEs. Screening for SAEs and AEs will be done using a symptom questionnaire as well as by asking patients during our interview. Fecal samples will be collected from participants on months one, three and six post-IMT to assess for changes in recipient microbiome (engraftment kinetics).
We will sample intestinal microbiota using a microbiome sampling capsule in patients with Small Intestinal Bacterial Overgrowth (SIBO)
The FeMicrobiome study will evaluate gut microbiome features and their relationships with dietary iron absorption in healthy adults. The investigators hypothesize that (1) the gut microbiota can be shaped by the heme and non-heme Fe content of the diet and that (2) this will influence individual variation in dietary Fe absorption.
Alcohol use disorder (AUD) has been associated with high prevalence of inflammation-associated co-morbidities in people living with HIV even those receiving effective antiretroviral therapy (ART). Our preliminary data support a model in which the combined insult of AUD and HIV on the gut, specifically on the microbiota and intestinal barrier integrity, exacerbates inflammation. Our preliminary data using intestinal organoids also suggest a potential mechanism for AUD-mediated changes in the gut barrier function during HIV; the intestines of HIV+ individuals have low resilience to alcohol induced intestinal barrier disruption caused by high levels of oxidative stress. Finally, our preliminary data also suggest a potential approach to enhance the integrity of the intestinal barrier and reduce gut derived inflammation in people living with HIV with/without AUD- short chain fatty acid prebiotics. These prebiotics prevent alcohol mediated adverse effects on the intestinal barrier and inflammation by preventing oxidative stress. These prebiotics are safe and decrease gut inflammation in humans. 20 HIV+ ART+ (10 AUD- and 10 AUD +), will be recruited for a prebiotic intervention. This is a proof-of-concept observational study to establish a causal link between microbiota-gut and HIV pathology during ART by asking whether modifying microbiota and gut milieu impacts intestinal barrier function, systemic inflammation, and brain pathology in HIV+ people. Participants will have two study visits, where stool collection and blood draw will be collected, as well as questionnaires. These participants are part of the larger observation study (n=160), which will test the hypothesis that intestines from HIV+ individuals have lower resilience to alcohol mediated gut barrier disruption than intestines from HIV-negative controls. We will recruit the following groups of participants: HIV+ ART+ AUD-; HIV+ ART+ AUD+; HIV- AUD- ; HIV- AUD+. Blood, urine, stool, and intestinal biopsies will be collected from participants to compare intestinal barrier integrity, system and gut inflammation, immune activation, oxidative stress, microbiome/metabolome. and HIV reservois. Second, lleal/colonic organoids from HIV- and HIV ART+ individuals will be generated to examine their resilience to alcohol-induced intestinal barrier disruption.
This trial evaluates the effects a moderate-to-vigorous exercise intervention has on the bacterial make-up of the gastrointestinal tract (gut microbiota) in survivors of stage II-III colorectal cancer (CRC). Data shows that the gut microbiota composition and function may be drivers of CRC. High levels of exercise are associated with improved CRC prognosis and survival. While data suggests that exercise has the potential to influence gut microbiota composition and function, it is not known whether these effects contribute to improved CRC prognosis. This clinical trial evaluates the effects an exercise intervention has on gut microbiota and how these effects relate to CRC progression and patient-reported outcomes.
Sweet cherries (Prunus avium) are a good source of bioactive compounds including dietary fiber and phytochemicals which have been credited with multiple health benefits, including anti-inflammatory and antioxidant properties as well as preventing obesity-related metabolic disorders. However, most studies have shown such benefits using in vitro or animal models. The aim of this study was to examine the influence of DSC consumption on obesity-associated inflammation, metabolic disorders, cognitive impairment, and gut dysbiosis in obese individuals.
This study will evaluate the effect of the microorganisms in the gut on how well the flu or COVID-19 vaccine works in people who have a weakened immune system due to inflammatory bowel disease. Participants can expect to be in the study for up to 65 days.
The purpose of this research study is to test the safety, tolerability, and effectiveness of the capsules that contain bacteria from healthy individuals when used to treat alcohol craving and drinking.
This study aims to use a high-fiber supplementation, an intervention known to create shifts in the gut microbiota towards a healthier structure, to explore the relationship between gut microbiota, appetite control and feeding behavior in PWS patients.
This study will include a group of 60 Hispanic adults living in New Hampshire with or without overweight/obesity. The study aims to assess food access and intake of fiber-rich foods, characterize fecal microbiota composition, and assess the relationship between the intake of fiber-rich foods and components of the gut microbiota-gut-brain axis. These aims will be accomplished through biospecimen collection including a pre-collected stool sample, a fasting blood sample, and a Mixed Meal Tolerance Test (MMTT). In addition, participants will answer questionnaires on dietary intake, food insecurity and access, physical activity, eating behavior, and sociodemographic characteristics.
Obesity is a growing health issue that effects the majority of adults in the United States. Prevalence of other metabolic diseases are increased in obese adults, including systemic inflammation. There is emerging evidence that the gut microbiota have a mediating role in controlling inflammation by producing butyrate when ingested fiber is fermented. Since these microbes are modifiable by diet, the investigators plan to introduce walnuts to the diets of participants with obesity because they are rich in fiber and unsaturated fatty acids. The purpose of this study is to understand the impacts of walnut consumption on the gut microbiota and the effect they have on bile acid profiles and systemic inflammation. The investigators intention is to identify how these walnut-derived molecules influence Faecalibacterium spp., a butyrate producing microbe. Increased levels of butyrate have shown to decrease secondary bile acids and decrease inflammation.
Emerging evidence supports the existence of a microbiota-gut-brain axis through which gut microbes influence cognition, mood and behavior. Targeting this axis with probiotics and/or prebiotics may provide novel strategies for mitigating stress-induced decrements in gastrointestinal and cognitive function. This double-blind, placebo-controlled, randomized, parallel-arm trial will determine the effects of a prebiotic and a probiotic dietary intervention on gastrointestinal, cognitive and physiologic responses to acute military-relevant physical and cognitive stress. Healthy men and women will be recruited and randomized to receive a placebo, probiotic or prebiotic for 4wk. Volunteers will be fed a controlled diet during the 4th week of supplementation. Fecal, blood, urine and saliva samples will be collected. Physical stress will be induced by a weighted walk on a treadmill, and will be followed by a cognitively challenging testing scenario that uses intermittent electric shocks to the abdomen to induce a stress response.
Advancing age is associated with gut dysbiosis, low-grade chronic inflammation, progressive insulin resistance, and increased risk of type 2 diabetes (T2D). Prediabetes is present in 45-50% of middle-aged/older adults, and declines in glucose tolerance are evident in the third or fourth decade of life. Thus, there is an urgent need to identify new approaches for the prevention of type 2 diabetes among middle-aged adults. Observational research has linked intake of ultra-processed foods (UPF), which comprise \~60% of total energy intake in US adults, with increased risk of T2D. Ex vivo and animal research suggests that components of UPF alter gut microbiota composition and initiate a cascade of events leading to intestinal inflammation and impaired glycemic control. Whether mid-life adults (aged 45-65 yrs) are susceptible to the adverse impact of UPF consumption on glucose homeostasis is unknown. The overall objective of this study is to establish proof-of-concept for an impairment in glucose homeostasis following increases in UPF consumption in mid-life adults, in order to conduct a larger, more comprehensive and mechanistic trial in the future. In addition, changes in gut microbial composition and function, intestinal inflammation and permeability, serum endotoxin concentrations, and inflammatory cytokines as potential mechanisms by which UPF consumption influences glucose homeostasis will be investigated.
Caribbean Latino adults are a vulnerable population at risk for developing osteoporosis. In addition to lifestyle factors, such as dietary intake, the investigators hypothesize that a unhealthy gut microbial environment coupled with high inflammation contributes to the risk of developing osteoporosis. There has been little research conducted on mechanisms underpinning how a low-intensity dietary intervention, including supplementation with daily yogurt, can affect the gut health of Caribbean Latino adults. The study objectives are to: 1) determine whether daily yogurt supplementation reduces bone turnover (biomarkers of overall bone health) and inflammation compared to a control group that maintains their usual diet (void of yogurt); and 2) collect preliminary data on the effects of daily yogurt supplementation on the gut microbiome compared to diet control group.
The purpose of this research is to test if eating walnuts will cause any changes in blood lipids (like good and bad cholesterol, for example) and levels of inflammation in the blood, as well as changes in the bacteria living in the gut.
This study will investigate the gut microbiota-mediated effects of whole wheat consumption on human health in adults with pre-diabetes. Participants will complete two phases of intervention in random order in which they will consume either whole wheat bread (4 servings) or white bread a day for two weeks prior to collecting specimens (stool, urine, and plasma/serum).
While many empirical projects have described multiple potential health benefits of CBD, the potential for CBD to provide protection against the development of diabetes via favorable modification of the gut microbiota has received relatively less attention. We hope to learn if CBD can improve glucose tolerance and the gut microbiota, and if these two improvements might be related.
This exploratory study is to compares mechanisms of mind-body exercise with wellness education program on gut microbiota for osteoarthritis as a basis for a future large-scale trial.
Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes. Longitudinal studies that examined pre- to post-surgery changes in gut microbiota and its relation to cardiometabolic health after surgery are limited. Furthermore, few studies have included African Americans, a population with high rates of cardiometabolic diseases. The investigators aim to fill these research gaps by establishing a longitudinal, observational study of metabolic surgery patients and applying multi-omics to identify stool, blood, and/or tissue microbial features related to post-surgery cardiometabolic outcomes. In the current study, the investigators plan to enroll up to 300 patients who undergo metabolic surgery at Vanderbilt University Medical Center and follow them for up to 10 years after surgery. Fasting blood and stool samples will be collected at pre-surgery and 3-month, 1-year, 2-year, and 3-year post-surgery clinical visits. Tissue samples (e.g., biopsies of the liver and adipose and remnants of the stomach) will be collected during operation. Meanwhile, participants will complete a REDCap survey at baseline and 1-year, 2-year, and 3-year post-surgery. Participants' electronic medical records will be used to obtain additional information and facilitate long-term follow-up. The investigators will evaluate pre- to post-surgery changes in the fecal microbiome and fecal and blood levels of metabolites and proteins and the associations of microbiome, metabolites, and proteins with cardiometabolic improvements after surgery. This study will advance our understanding of the role of gut microbiota in metabolic surgery, which may translate into novel approaches to identify and treat obese patients for better cardiometabolic health.
The purpose of this research is to determine if different diets have different effects on the inflammation in the colon.
Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota following introduction of Xla1 performed in 2 parts: * Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1. * Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or obese (stage 1) adult patients receiving either Xla1 or placebo.
In this prospective study, the primary objective will be to investigate the association between the use of antibiotics administered during the admission period of Stem cell transplant (SCT) and the rate of overall change in microbiota composition across adjacent samples in time.