Clinical Research Directory

Effects of Daily Kefir Consumption During Medical Nutrition Therapy on Body Composition and Psychological Well-Being in Women With Obesity

This randomized controlled study evaluated the effects of daily kefir consumption as an adjunct to medical nutrition therapy on body composition, biochemical parameters, gastrointestinal symptoms, bowel habits, and psychological well-being in women with obesity. Participants were randomly assigned to receive either 200 mL of plain kefir daily together with individualized medical nutrition therapy or individualized medical nutrition therapy alone for 12 weeks. Assessments were performed at baseline, week 6, and week 12. The primary outcome was change in body weight. Secondary outcomes included changes in body composition, biochemical parameters, gastrointestinal symptoms, bowel habits, and psychological well-being.

Gut Microbiota Structure, Functional and Metabolic Profiles, and Composite Biomarkers in ICU Adults With Refractory Enteral Feeding Intolerance

Some adults in the intensive care unit (ICU) cannot receive enough nutrition through a feeding tube because of persistent digestive problems, even after standard measures to improve feeding. This condition is called refractory enteral feeding intolerance. The community of microorganisms living in the gut, known as the gut microbiota, and the substances produced by these microorganisms and the body may be associated with feeding tolerance and recovery. This prospective observational study will enroll approximately 180 adults with refractory enteral feeding intolerance at a single hospital. It aims to describe changes in their gut microbiota and metabolic profiles over time and identify combinations of microbial markers associated with improved feeding tolerance and adequate nutritional intake. Stool samples or rectal swabs will be collected at enrollment, on days 3-5 and day 7, and, when feasible, near the end of the ICU stay. The samples will be used to examine the types of microorganisms present. Selected samples will also be analyzed for metabolic substances. Clinical information about nutrition, digestive symptoms, medications, illness severity, and treatments will be collected. Participants will be followed for up to 90 days to assess survival and unplanned hospital readmissions. The study will examine whether microbial and metabolic patterns provide additional information about feeding improvement by day 7 beyond routine clinical assessments. Where suitable public datasets are available, findings will also be evaluated in other patient groups. Participants will continue to receive usual medical care. The study does not assign treatments or change feeding decisions. Its findings may help guide future research on feeding intolerance, but participants are not expected to receive a direct medical benefit from taking part.

Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.

This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will be recorded. Infants will be randomly assigned to receive either the test or control product. Growth and health data will be collected during study visits. Parents will collect stool samples and complete diaries to help researchers better understand the baby's digestion and overall health. A follow-up phone call will be made to check on the baby's well-being after the study ends.

The Impact of Overnight Active Temperature Regulation on Gut Microbiome, Inflammation, and Circadian Rhythm.

This study examines whether two continuous weeks of overnight active temperature regulation (via the Eight Sleep Pod) use affects gut microbiome composition, inflammation, and the body's daily temperature and blood pressure rhythms in postmenopausal women and age-matched men with self-reported poor sleep.

Fiber Smoothie Supplement

This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that integrated a daily whole food plant-based smoothie into their diet for two weeks prior to surgery, and a control group of revision TKA patients that made no nutritional changes to their diet prior to surgery. The main research questions are: 1. Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? \[Outcomes will be compliance, noted barriers and/or facilitators, satisfaction with diet\] 2. Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will reduce inflammation -measured in plasma levels of IL-6 and CRP- at POD0, POD1, POD2, POD3, and 6 Weeks Post-operative as compared to 1) baseline (prior to dietary intervention initiation) and 2) control patients who did not make changes in their diet prior to surgery. 3. Determine if the implementation of a daily whole food plant-based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in quantifiable changes in the gut microbiome composition -measured via fecal samples- as compared to control patients who did not make changes in their diet prior to surgery. 4. Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in improved immediate postoperative pain -measured through numeric rating scale (NRS) pain scores- and opioid use -measured in morphine milligram equivalents (MME)- as compared to control patients. 5. Compare patient satisfaction and adoption of nutritional behavioral changes in patients implementing a whole food plant-based smoothie 2 weeks prior to TKA revision surgery to patients undergoing the same surgery but did not me pre-surgery dietary changes. The researcher's primary outcome is measuring feasibility and patient compliance with smoothie consumption. Secondarily, the investigators are interested in measuring if the preoperative smoothie can alter the gut microbiome and decrease systemic inflammation, leading to lowered post-operative pain and opioid use.

GBPDC: Gut-Brain in PD Consortium Master Protocol

The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study. During this study, specific groups of participants, also known as "cohorts", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection. Participants in this study will: * meet with a medical provider * answer questionnaires * give samples of blood, stool, and saliva * have X-rays taken while swallowing different foods (swallowing study) * have X-rays taken to see how long it takes markers to move through their colon (colon transit study) * have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining) * have samples taken of their skin * have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function. Participation in the study will last up to 24 months (2 years).

Restrictive Versus Standard Antibiotic Treatment During CAR-T Therapy

The purpose of the CARMic study is to investigate whether a restrictive, microbiome-sparing antibiotic strategy can better preserve the gut microbiota in patients undergoing chimeric antigen receptor T-cell (CAR-T) therapy without compromising infectious safety. This is a randomized, open-label Phase II trial enrolling 150 adults with large B-cell lymphoma or multiple myeloma who are scheduled to receive standard-of-care CAR-T therapy. Participants will be randomly assigned in a 1:1 ratio to either a restrictive antibiotic strategy based on ceftazidime and/or ciprofloxacin or an unrestricted standard-of-care antibiotic strategy. The assigned strategy will apply from randomization until 28 days after CAR-T-cell infusion. Antibiotic treatment may be modified or broadened at any time when clinically indicated. The primary question is whether the restrictive antibiotic strategy results in greater gut microbial diversity 28 days after CAR-T-cell infusion compared with standard-of-care antibiotic treatment. Gut microbial diversity will be assessed in stool samples using the Shannon diversity index. The study will also compare infections, antibiotic exposure, adherence to the assigned strategy, CAR-T-related toxicities, treatment response, relapse, progression-free survival, and overall survival between the two groups. Changes in gut microbiota composition and in blood and stool metabolomic and proteomic profiles will be evaluated over time. Blood and stool samples will be collected at randomization, around the time of CAR-T-cell infusion, 28 days after infusion, and at the end-of-treatment evaluation approximately 3-6 months after infusion.

Phenolic Dependent And Independent Effects Of Whole Grain Sorghum On Immunometabolism

Sorghum is a nutrient-dense ancient grain that, when eaten as a whole grain, provides health-beneficial dietary fiber, protein, and phenolics. The goal of this clinical trial is to learn about the phenolic-dependent and independent effects of whole grain sorghum in adults with excess body weight. The main questions it aims to answer are: * Are markers of immune and metabolic health affected differently by eating high- vs low-phenolic whole grain sorghum? * Does the gut microbiome respond differently to eating high- vs low-phenolic whole grain sorghum, and does this response explain the health effects? Researchers will compare foods made from (1) whole grain sumac sorghum (high phenolic profile), (2) whole grain white sorghum (low phenolic profile), and (3) white rice (control) randomly to identify the health benefits of sorghum relative to white rice. Participants will: * Consume three study foods daily during three intervention phases, with each phase lasting four weeks. The three study foods will be a cereal, crispy breadstick, and grain pouch product, which will be made from one of the study grains (sumac sorghum, white sorghum, or white rice). * Complete questionnaires asking about demographic, diet, lifestyle, quality-of-life, health, and gut health information. * Have height, weight, waist circumference, body composition, and blood pressure measured. * Wear a continuous glucose monitor 3 times, each for 10 days. * Have six blood draws, one saliva sample collection, and provide six stool samples. * Maintain a study journal during the three intervention phases.

Organoid Models of Hepatocellular Carcinoma

A promising tool to elucidate the molecular characteristics of HCC are patient-derived organoids (PDOs), three-dimensional cultures of cells that self-organise according to tissue-specific patterns and can be used to test the susceptibility of a specific tumour to anticancer agents. In this study, PDOs for HCC will be developed that closely resemble the tumour microenvironment in vivo and mimic the crosstalk of the gut-liver axis to establish a correlation with patient prognosis and test the efficacy of available systemic therapies.

Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients

An observational cohort was established using preoperatively collected biospecimens and prospectively ascertained postoperative outcomes. A nested case-control metagenomic analysis was subsequently conducted within the cohort, including participants with grade II or higher PPCs and selected participants without PPCs.

Susceptibility to Infectious Diseases in Obesity

The role of intestinal microbiota is becoming ever more important in the context of obesity, type II diabetes (T2D), and infectious disorders as represented by the emerging discipline "therapeutic microbiology". The gut microbiota is strictly interconnected with obesity and T2D playing also an important role in immune system regulation. Obesity and diabetes can lead to chronic inflammation, which results in the secretion of pro-inflammatory cytokines like IL-6, IL-1, and TNF-alpha, causing immune system alteration which predisposes patients with obesity and T2D to chronic infections. Therefore, the principal aim of the study is to investigate changes in gut microbiota composition between patients with chronic infections or not, so as to attribute to specific phyla the formation of the infections in these patients.

How a Single Workout Affects Gut Bugs in Women With Different Fitness Levels and Body Types

This study aims to elucidate the differences in the gut microbiome functional activity and metabolome in adult premenopausal women with distinctive fitness levels and BMIs (with obesity, w/o obesity). The specific aims are as follows: * Aim 1: To examine the effects of acute aerobic exercise at 60-70% heart rate reserve (HRRmax) for 30 minutes bout on changes in the abundance of SCFA-producing bacteria and their functional downstream metabolic activity. * Aim 2: To examine the effects of acute aerobic exercise at 60-70% HRRmax 30-minute bout on changes in GM-released SCFA concentrations in stool and plasmatic metabolome.

Effect of Raspberry on Gut Microbiota and Metabolic Syndrome

There is growing evidence that nutritional intervention with dietary polyphenols can positively modulate the gut microbiota to improve cardiometabolic health. Whether the beneficial effects of raspberry on obesity and the metabolic syndrome can be linked to their potential impact on the gut microbiota and intestinal integrity remains speculative at this time. Moreover, the mechanisms of action underlying health benefits associated to raspberry consumption are still unknown. The investigators are thus proposing to combine the study of metagenomics, transcriptomics and metabolomics to test whether a prebiotic activity of raspberry can play a role in the prevention of obesity-linked metabolic syndrome in a clinical setting.

Effects of Blueberry on Gut Microbiota and Metabolic Syndrome

There is growing evidence that nutritional intervention with dietary polyphenols can positively modulate the gut microbiota to improve cardiometabolic health. Whether the beneficial effects of blueberries on obesity and the metabolic syndrome can be linked to their potential impact on the gut microbiota and intestinal integrity remains speculative at this time. Moreover, the mechanisms of action underlying health benefits associated to blueberry consumption are still unknown. The investigators are thus proposing to combine the study of metagenomics, transcriptomics and metabolomics to test whether a prebiotic activity of highbush blueberries can play a role in the prevention of obesity-linked metabolic syndrome in a clinical setting.

Effect of Non-nutritive Sweeteners of High Sugar Sweetened Beverages on Metabolic Health and Gut Microbiome

Increasing evidence suggest that artificial sweeteners such as saccharin, aspartame and sucralose may not be as metabolically safe as they first appeared, and it has been proposed that their consumption may be linked to important disturbances in the gut microbiome. Some in vitro and in vivo studies suggest that the recently approved sugar substitute Stevia (eg. steviol glycosides) can also influence intestinal homeostasis. However, it is not clear whether this natural non-nutritive sweetener (NNS) could also cause metabolic and microbiome disturbances as proposed for their synthetic counterparts. In fact, steviol glycosides may even have a beneficial impact on glucose homeostasis and lipid metabolism possibly through a positive action on intestinal health and gut microbiome, but this has yet to be experimentally tested in a rigorous study. The main objective of this project is to evaluate whether steviol glycosides sweetened beverages (SGSB) or aspartame/acesulfame K sweetened beverages (AASB) exert beneficial, neutral or detrimental effects on metabolic health of regular consumers of sugar-sweetened beverages (SSBs), and whether modulation of the gut microbiome is involved in the resulting impact of these NNSs on metabolic health. As chronic overconsumption of SSBs is clearly associated with an increased cardiometabolic risk, this study will be the first to determine the metabolic impact of replacing SSBs by potentially "healthier alternatives" such as the increasingly popular stevia-based soft drinks and aspartame-based soft drinks. The investigators will further investigate whether these NNS can cause pernicious effects on intestinal health and the gut microbiome. It is a crucial concern since the importance of this unsuspected key "organ" has been ignored for too long and its important implication in many chronic societal diseases has just been discovered. Results of this study could have a direct influence on health, nutrition and even agricultural policies as well as dietary guidelines around the world. This project is also critically important as an increasing amount of health professionals such as physicians, nurses and registered dietitians seek to provide evidenced-based guidance to individuals looking for healthier alternatives to SSBs including stevia-based or aspartame-based soft drinks.

Analysis of the Role of the Microbiota in Diverticular Disease

A single-center, prospective observational cohort study conducted at the University Hospital of Navarra. The primary objective is to expand knowledge of diverticular disease and its pathological variants, as well as the influence of the microbiota in our environment, both clinically and molecularly; to describe the clinical and pathological characteristics of patients with diverticulosis and acute diverticulitis; to analyze any differences in the microbiota; and to identify the risk factors and groups associated with diverticular disease in order to establish the best strategies for prevention and treatment.

Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes

The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.

Peanuts for Cardiometabolic, Brain, and Intestinal Health

The overall objective of this 14-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.

Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude

Microbes and the human body maintain a complex relationship of interaction and influence. Different regions, altitudes, and dietary habits have different degrees of influence on the composition of children's intestinal flora. Therefore, the development and maturation process of children's intestinal flora in plateau areas was discovered, and its relationship with children's immunity, metabolism, and growth was understood. The mechanism of action of children's intestinal flora on immunity, growth and development was further analyzed by comparing it with people in low-altitude areas, to provide a scientific basis for improving children's health in plateau areas.

Gut Microbiota and Metabolic Development in Early Childhood: A 3-Year Follow-Up Study

This prospective observational birth cohort study aims to characterize the longitudinal development of the gut microbiome during early childhood and to investigate its associations with prenatal, perinatal, and postnatal exposures and child growth and health outcomes. Approximately 1000 pregnant women will be enrolled, and their children will be followed from birth to 36 months of age. Information on parental demographic and lifestyle characteristics, maternal pre-pregnancy and pregnancy-related factors, prenatal examinations, delivery characteristics, infant feeding, medication use, illnesses, and household and environmental factors will be collected through questionnaires and medical records. Child anthropometric measurements and fecal samples will be collected at birth and at 1, 3, 6, 9, 12, 18, 24, and 36 months of age. The fecal microbiome will be characterized using shotgun metagenomic sequencing.Umbilical cord blood will be collected at delivery from all participants, subject to informed consent and hospital procedures. At 36 months of age, residual venous blood remaining after routine health examinations and clinically indicated laboratory testing will be retained for research from all participating children. The study will evaluate the developmental trajectories of the early-life gut microbiome and identify maternal, paternal, perinatal, feeding-related, medication-related, and environmental factors associated with microbiome development and subsequent child growth and health.

Effects of Grape Powder on Psychological Distress and Gut Microbiota in College Students

The goal of this trial is to investigate the effect of freeze-dried table grape powder (FTGP) on psychological distress and gut microbiota in college students. The main questions it aims to answer are: Does FTGP reduce anxiety, depression, and perceived stress? Does FTGP improve the gut microbiota? Researchers will compare FTGP to a placebo to see how FTGP affects psychological distress and gut microbiota. Participants will: Drink a daily supplement containing FTGP or a placebo for 4 weeks. Record consumption of grape powder or placebo in a compliance log. Complete surveys and provide stool samples. Three in-person visits.

Effect of Agave Inulin Supplementation on Metabolic Profile and Intestinal Abundance of Bifidobacterium and Lactobacillaceae in Adults With Type 2 Diabetes Mellitus

This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effects of agave inulin supplementation on metabolic profile and intestinal abundance of Bifidobacterium and Lactobacillaceae in adults with type 2 diabetes mellitus. Participants will receive either 10 g/day of agave inulin or a placebo for eight weeks. Clinical, anthropometric, biochemical, and gut microbiota assessments will be performed at baseline and at the end of the intervention. The study seeks to determine whether agave inulin supplementation improves metabolic outcomes and modulates beneficial intestinal microorganisms associated with metabolic health in adults with type 2 diabetes mellitus.

Microbiota Profiles in Newly Married Couples: Potential Effects on Vision, Sleep and Psychometric Parameters

Oral, fecal and conjunctival samples will be collected from participants and will be stored (at - 20 and - 80 ◦C) until further processing. On Day 1 and Day 2, all couples will participate in an oral, conjunctival and gut microbiota composition study. Optometry examinations will be completed for each participant Three and Six months later, oral, conjunctival and gut microbiota composition will be analyzed again with the same protocol. The participants will complete a validated Persian version of Pittsburgh Sleep Quality Inventory (PSQI), Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), global sleep assessment questionnaire (GSAQ) and Ocular Surface Disease Index. Consecutive couples will undergo a standard ophthalmology exam and specific assessments for dry eye, including non-anesthetic Schirmer's test and fluorescein tear break-up time on Day 1 and Day 90.

Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease (PD) - Use Preclinical Human Trials to Confirm the Impact of the Optimal "Probiotic Y7, Tryptophan and Branched-chain Amino Acid" Cocktail Formula on Early Stage PD Patients

Preclinical human trials will be utilized to validate the research direction, followed by clinical trials to assess the impact of a cocktail formula product containing the optimal probiotic Y7 combined metabolites on motor, cognitive, and non-motor functions in early Parkinson's disease patients. The study aims to recruit 120 patients (stage 1-3) and employ a two-arm, randomized controlled trial (RCT) design, dividing subjects into intervention and control groups for a 12 weeks trial period. Commercial development will be contingent upon the clinical trial outcomes, evaluating whether the product offers clinical benefits such as delaying Parkinson's disease progression in motor, cognitive, and non-motor functions. Additionally, a personalized and precise prognosis prediction model for Parkinson's disease will be established. This model will gather comprehensive clinical data, including motor function assessments (functional tests, UPDRS), biochemical markers, questionnaire responses, and genotype data (TPM array), as well as metabolite and microbial data. Through integrated analysis of this biological information using machine learning techniques, a personalized and accurate prognosis prediction model for Parkinson's disease will be developed. This model will predict the disease status of PD patients 12 weeks later, accounting for factors such as cocktail therapy. The results will empower PD patients to understand their individual disease progression and treatment prognosis, enabling them to prepare accordingly. Moreover, this model will aid researchers in identifying patient profiles more likely to benefit from treatment, thereby enhancing the evaluation of the efficacy and applicability of cocktail therapy.