Clinical Research Directory

Effect of Peanut Butter on Gut and Metabolic Health

The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. The main objectives are: Primary Objective: To determine the prebiotic effect of daily smooth peanut butter consumption for eight weeks on gut health, including microbiome-metabolome arrays, gut epithelial/barrier function, and gut transit time, in school-aged children. Secondary Objective(s) 1. To determine the effect of daily smooth peanut butter consumption for eight weeks on metabolic and inflammatory health markers, and measures of sleep quality in school-aged children. 2. To determine the potential mechanisms and feasibility of incorporating peanut butter into the diets of school-aged children as part of healthy, personalized nutrition. Research Intervention(s): Researchers compare two groups to see if there really is an effect of daily smooth peanut butter intake on gut and metabolic health. The two groups are: 1. The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers. 2. The 2nd condition (CTL) includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread, sandwiched between two plain unsalted saltine crackers.

Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota

The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women's menstrual and sexual health remains extremely limited. Whether societal or pathological, many hypotheses are emerging regarding the effects of menstrual protection products, yet little attention has been given to the products themselves, their societal role, or their physiological and pathological consequences. Internal menstrual products, such as tampons and menstrual cups, are widely used but are subject to limited regulatory oversight, and few studies have investigated their long-term effects on vaginal health. This study aims to investigate how different types of menstrual protection influence vaginal microbiota, immune responses, and the recurrence of gynecological conditions such as bacterial vaginosis, mycosis, or dysbiosis. Biological samples (vaginal, cervical, urinary, and blood) will be collected to analyze vaginal microbiota composition and local immunity. Participants will be divided into three groups based on their main type of menstrual protection: menstrual cup users, tampon users, and external pad users. The study will compare these groups to assess potential differences in vaginal health and immune response related to menstrual product use.

Effect of Watermelon on Gut and Cardiometabolic Health

The goal of this clinical trial is to evaluate the effect of daily fresh watermelon consumption for 6-weeks on gut health, including microbiome diversity, gut barrier and immune function in young adults with overweight and obesity. The main questions it aims to answer are: 1. Will consuming fresh watermelon daily for 6-weeks will improve intestinal barrier health and increase microbiome diversity such as an increased population of beneficial 'probiotic' bacteria when compared to control participants consuming a low-fat snack? 2. Will consuming fresh watermelon daily for six-weeks will improve other health measures, including body-composition, blood pressure, blood vessel function, blood lipid profiles, and measures of inflammation, as compared to control participants consuming a low-fat snack for the same time period?

Microbiome Alterations With Xylitol (MAX) in Pregnancy

The purpose of this study is to understand if chewing xylitol-gum initiated before 20 weeks of pregnancy and continued until delivery affects the bacteria that are found in the oral and vaginal cavities, signs of inflammation within the gingiva of the oral cavity, the health of the tissues in the mouth (clinical parameters of periodontal disease) and placentae, and the bacteria in the mouth and gut of newborns among pregnant individuals in Malawi. In addition, we will evaluate the impact of xylitol-containing chewing gum use during pregnancy on the offsprings neurodevelopment at approximately 6- and 18-months corrected age.

REMBRANDT: REcovery of the MicroBiome fRom Antibiotics for Dental implanTs

Antimicrobial therapy can lead to disruption of the gut microbiome and infection with Clostridioides difficile, a disease associated with high morbidity and mortality, particularly among the elderly. Drawing on observations that pet ownership and close contact with pets are protective against colonization with C. difficile and recurrence of C. difficile infection, the proposed study will test the hypothesis that microbiota that provide colonization resistance against C. difficile are shared between patients and their pets and that pet contact can mitigate antimicrobial-associated gut dysbiosis and the risk of C. difficile infection. This study will further define epidemiologic and pathophysiologic characteristics of C. difficile infection and gut microbiome dysbiosis that could enhance therapeutic options for these conditions, potentially through non-invasive interventions involving animal contact.

BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months

Infants often experience functional gastrointestinal symptoms (e.g., colic, excessive gas, regurgitation, constipation, or loose stools) that distress families and may reflect an imbalance of the gut microbiome. This study evaluates whether the multistrain probiotic BioAmicus Complete can improve caregiver-reported gastrointestinal symptoms in infants 0-24 months and is safe for use in this population. The primary assessment is the change in the Infant Gastrointestinal Symptom Questionnaire (IGSQ) total score from the start to the end of the study period. Secondary assessments include symptom domains (colic/regurgitation, stool frequency and consistency), caregiver quality of life, growth parameters (weight and length), health care utilization and antibiotic exposure, and overall safety/tolerability (adverse events and serious adverse events). Stool samples will be analyzed to explore changes in the gut microbiome.

A Study of Healthy Microbiome, Healthy Mind

Researchers are doing this study to find out if a high fermented food diet is tolerable, and if it will help improve quality of life after surviving a critical illness, including severe COVID-19, by promoting gut health recovery and decreasing gut inflammation.

Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)

Patients treated for gynecological tumors with radiotherapy (RT) and/or chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.

Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa

The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).

Assessing Gut Microbiota Mediated Health Outcomes of Whole Wheat and Its Major Bioactive Components

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).

The Effect of Glucomannan Powder on Improving Gut Microbiota.

The object of this study is evaluating the effects of the Glucommanan on the healthy human subjects who are. In this trial, at most 30 healthy subjects whose ages are 20\~65 years old (15 for placebo and 15 for intervention)will be included. The total experiment will be 9 weeks and the intervention period will be 6 weeks, within which, at week 0, 6, and 7, total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), aspartate aminotransferase (AST, also known as GOT), alanine aminotransferase (ALT, also known as GPT), blood urea nitrogen (BUN), serum creatinine (Cr), fasting blood glucose (Glucose, AC) and adiponectin would be measured. Feces samples and anthropometric data will also be acquired. The results will be analyzed according to the methods published by the Ministry of Health and Welfare of Taiwan Food and Drug Administration.

Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor

The FLORA-ACS study aims to evaluate the relationship between dysbiosis and high platelet reactivity during treatment with ticagrelor in patients with a history of acute coronary syndromes and investigate the use of rifaximin to eliminate dysbiosis and thus provide effective antiplatelet treatment.

Impact of Dysbiosis-inducing Drugs on Effectivity of Immune Checkpoint Inhibitor in Non-small Cell Lung Cancer Patients

Lung cancer is the leading cancer in France in terms of mortality. The prognosis of the disease is closely correlated with the diagnostic stage and the majority of patients are diagnosed at a metastatic stage. The arrival of immunotherapy has made it possible to change the therapeutic paradigm by significantly improving the survival of metastatic patients. Despite this progress, only 20 to 30% of patients respond to immunotherapy. The search for predictive factors of response to or resistance to these drugs is of major importance for better patient selection. Among these factors, the intestinal microbiota appears to be closely correlated with the response to immunotherapy via the education of adaptive anticancer immunity. Thus, several bacterial species have been associated with patient survival or disease progression. Interestingly, the abundance of these same bacteria can be modulated by certain drugs co-prescribed with immunotherapy. These dysbiotic treatments or those leading to a significant modification of the composition of the intestinal microbiota could then modulate the response to immunotherapy and therefore patient survival. The objective of this study is therefore to objectify the impact of several therapeutic classes modifying the intestinal microbiota initiated in the 90 days preceding D1 of immunotherapy on the survival of patients with locally advanced (stage III-C) or metastatic (stage IV) non-small cell lung cancer (NSCLC)

Probiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee

Prosthetic joint infection (PJI) is one of the most devastating complications following total joint arthroplasty (TJA) of the hip and knee. Standard of care (SOC) treatment includes surgery and antimicrobials. Morbidity and mortality remain high despite contemporary treatments. The human body is colonized by billions of organisms, collectively, the microbiome, which is central to healthy immune function. Microbiome disruption, dysbiosis, can impair the immune response to infection. Despite recent evidence that suggests dysbiosis may be implicated in PJI, the role of probiotics in the treatment of PJI is unknown. Perioperative probiotics have been demonstrated to be safe and effective for infection prevention in abdominal surgery. The investigators hypothesize that perioperative probiotics will reduce re-infection in patients treated for PJI. A multi-centered, randomized controlled trial (RCT) at two academic, tertiary care centers will be conducted to determine the impact of probiotics on recurrent infection following treatment for PJI. Controls will receive SOC; study patients will receive a probiotic, started shortly after the initiation of and for the duration of their antibiotic therapy + 7 days, in addition to SOC. Primary outcome is re-operation for recurrent infection within 1 year.

The Influence of Probiotics on Metabolome and Heart Rate Variability in Heart Failure of Structure Heart Disease

Poor body weight gain and failure to thrive is a very common condition in patients with congenital heart disease (CHD) with advanced HF and/or cyanosis, which are considered a predictor of morbidity and complicate the prognosis of CHD. Studies have been carried out an attempt to discover the mechanisms to improve the therapies and the prognosis of these patients. Some of these studies give the hypothesis that the gastrointestinal tract, more precisely the intestine, can collaborate with metabolome. Extra-intracardiac shunt and HF lead to hypoperfusion and cyanotic heart disease leads to hypoxia. These two conditions make the gastrointestinal tract of these patients to become more mal-absorption to food. Consequently, the poor intestinal microcirculation and resultant dysbiosis may contribute to poor body weight gain and the worsening of prognosis. As known, probiotics can help to maintain or recover the microbiota and maintain a healthy intestinal barrier. In view of the importance of microbiota to the metabolism and the possible beneficial effect in the prognosis of heart-failure patients and the performance of microbiota in maintenance of intestinal barrier, this study has as primary objective to verify the influence of supplementation of the probiotic Lactobacillus Rhamnosus in the patients with CHD. Malabsorption and dysbiosis in patients with CHD Poor body weight gain and failure to thrive is a very common condition in patients with congenital heart disease (CHD). Dysbiosis occurs in patients with CHD. Such dysbiosis and intestinal barrier dysfunction may become worsen after they underwent cardiopulmonary bypass, and complicate the prognosis of CHD. Probiotics and Metabolome in Heart failure Cumulative evidence shows increasing importance of microbiota and cardiovascular disease and health. Metabolomic changes are found in CHD patients with hypoxia. It is suggested that Lactobacillus strains function to promote cardiovascular-related conditions. However, the effect of probiotic administration on CHD remains controversial. The investigators propose that hypothesis that Lactobacillus Rhamnosus directly improve the body weight gain and indirectly improve the outcome of patients with CHD. Accordingly, the investigators initiate this clinical trial to testify the beneficial effect of Lactobacillus Rhamnosus on CHD.

Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT

Among people living with HIV, heavy drinking increases the risk of heart disease and death. Studies suggest that alcohol changes the number and kind of bacteria in your gut and these changes increase the risk of heart disease and death. This randomized controlled trial will determine whether a pill containing healthy gut bacteria can increase the number good bacteria in the gut, lower levels of inflammation, and lower the risk of heart disease and death.

Association Between Fecal Microbiota Composition, Metabolite Concentrations, and Indoxyl Sulfate Levels

Gut dysbiosis is frequently characterized by decreased microbial diversity and alterations in the abundance of certain microbial species. In individuals with chronic kidney disease (CKD), dysbiosis and metabolic imbalances are prevalent, contributing to the buildup of gut-derived retention solutes and metabolites in the bloodstream. Research has consistently shown that CKD patients exhibit lower levels of beneficial gut bacteria. However, the specific functional changes in gut microbiota and their interactions with levels of uremic toxins in hemodialysis (HD) patients remain incompletely understood. This study seeks to explore the association of fecal metagenomics and targeted metabolomics in a cohort of 60 patients with different levels of to characterize the complex interplay between the gut microbiome and fecal and serum metabolites.

Oral Microbiota Dysbiosis in IBD

This study aims to provide new insights into oral microbiota dysbiosis and IBD. Given the strong association between oral health, microbiome composition, and IBD, all participants will undergo an oral evaluation program conducted by dentists from the Faculty of Dentistry at Universidade Católica Portuguesa (UCP). This program will facilitate the characterization of oral health and its correlation with IBD status.

Prebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women

The goal of this clinical trial is to assess the impact of table grape consumption on gut microbiome, intestinal permeability, systemic inflammation, and vascular function in healthy overweight men and women aged 45-70 years. The main questions it aims to answer are: * Does daily grape intake alter intestinal microbiome composition and intestinal permeability? * Are changes in gut microbiota and intestinal permeability correlated with changes in cardiometabolic risk factors (inflammation, vascular function, lipid profiles)? * Does response to grape intake on gut microbiota, intestinal permeability, cardiometabolic and inflammatory markers differ between men and women? * Are metabolic pathways modified by grape consumption able to explain the link between gut health and cardiometabolic factors? Researchers will compare freeze-dried grape powder to placebo powder to see if grape powder improves cardiometabolic risk factors. Participants will * Consume the powder dissolved in water twice daily for 3 weeks * Follow their usual diet, modified to limit polyphenol-rich foods * Visit the clinic at the beginning and end of the intervention for vascular measurements and blood sample collection * Complete a 3-day 24-hour dietary recall and collect stool sample before each visit

Effect of Lentils and Chickpeas on Gut Microbiome and Metabolic Health

The primary goal of this research is to evaluate the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on gut health, including microbiome-metabolome arrays and gut epithelial/barrier function, in healthy young adults. Secondary Objectives include: * To examine the effect of daily whole-cooked chickpea and lentil consumption for 8-weeks on the measures of metabolic health and inflammation in healthy young adults. * To determine the feasibility of healthy young adults to successfully incorporate and sustain the recommended daily intake of pulses into their diets for eight consecutive weeks Research Interventions: Participants will be asked to consume a normal diet supplemented daily with either A) whole-cooked canned lentils, or B) whole-cooked canned chickpeas. The control condition will be instructed to consume a normal diet while restricting all pulse intake throughout the study.

Oral Iron Supplementation for Patients With Chronic Kidney Disease

The hypothesis of this research is that oral iron prescribed in a single dose in alternate day could mitigate the side effects with regard to intestinal microbiota, inflammation, oxidative stress and improve the hematological profile when compared to daily oral iron prescription

Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development (PERMICA)

Colorectal cancer is the third most common cancer worldwide, yet it was the second leading cause of cancer-related deaths in 2020. The average French population faces a colorectal cancer risk partly linked to lifestyle factors. The majority of colorectal cancer cases (approximately 85%) are not caused by hereditary mutations. Environmental factors, such as lifestyle or diet (notably through endocrine disruptors), can affect the gut microbiota (a collection of microorganisms - bacteria, viruses, parasites, and fungi - residing in the intestinal environment) and lead to disturbances in its composition, referred to as dysbiosis. While the mechanisms underlying dysbiosis associated with colorectal cancer remain poorly understood, the involvement of certain ingested substances, known as xenobiotics, is increasingly suspected, including endocrine disruptors. Among the most common endocrine disruptors found in water and food are parabens and phthalates, which will be examined in detail in this study. These substances may be directly involved in the development of colorectal cancer and in response to its treatment. The main objective of this studie is to characterize the relationship between colorectal cancer diagnosis, activity/composition of the gut microbiota, and patients' exposure to selected endocrine disruptors, particularly parabens and phthalates.

PRObiotics for KIdney Transplantation

The goal of this clinical trial is to assess if dietary supplememtation with OMNi-BiOTiC® 41167 reduces the risk of urinary tract infections in kidney transplant recipients. It will also assess whether it reduces the risk of graft rejection, modify immunosuppressive regimen, improves post-transplant gastrointestinal and bladder microbiome, gastrointestinal symptoms and quality of life. The main questions it aims to answer are: * Does daily intake of OMNi-BiOTiC® 41167 reduce the incidence and number of episodes of urinary tract infections? * Does daily intake of OMNi-BiOTiC® 41167 reduce the incidence and number of episodes of acute graft rejection? * Does dietary supplementation with OMNi-BiOTiC® 41167 modify gut and bladder microbiome? * Does dietary supplementation with OMNi-BiOTiC® 41167 modify tacrolimus metabolism and immunosuppressive state? * Does dietary supplementation with OMNi-BiOTiC® 41167 improves gastrointestinal symptoms and quality of life? Researchers will compare drug OMNi-BiOTiC® 41167 to a placebo (a look-alike substance that contains no drug) to see if OMNi-BiOTiC® 41167 exerts any clinically relevant beneficial effect. Participants will: * Take OMNi-BiOTiC® 41167 or a placebo every day for 6 months * Undergo clinical surveillance with seriated visit the clinics for checkups and laboratory analysis * Provide seriated urine and stool samples for microbiome analysis * Respond to seriated questionnaire on gastrointestinal symptoms and quality of life

Evidence Based Probiotic Therapy of Proton Pump Inhibitor Induced Dysbiosis

In this study the investigators aim to test whether an evidence based probiotic is able to revert proton pump inhibitor induced dysbiosis of the gut microbiome.