[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gastrointestinal-microbiome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gastrointestinal-microbiome":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,56,90,117,143,168,193,222,254,281,306,346],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100641421","preoperative-fasting-and-the-gut-microbiome-before-hip-replacement-100641421",false,"NCT07651462","Preoperative Fasting and the Gut Microbiome Before Hip Replacement","Preoperative Metabolic Optimization: Influence of Intermittent and Buchinger-Type Fasting on the Gut Microbiome, Immune Profile, and Postoperative Complications in Patients Undergoing Primary Total Hip Arthroplasty - A Randomized Controlled Trial","PreFAST-Hip","Inclusion Criteria:\n\n* Adults aged 18-75 years (inclusive)\n* Scheduled for elective primary total hip arthroplasty (THA)\n* Able and willing to provide written informed consent\n* Able to follow the 20-day preoperative fasting protocol independently at home (if randomized to the fasting arm) or willing to be randomized to either arm\n\nExclusion Criteria:\n\n* Resorption disorder due to bowel disease (e.g. inflammatory bowel disease, short-bowel syndrome, active celiac disease)\n* Antibiotic therapy within the last 2 months before baseline (T0)\n* Probiotic, prebiotic, or symbiotic supplementation within the last 2 months before baseline (T0)\n* Inability or unwillingness to provide informed consent\n* Severe comorbidity precluding fasting (e.g. ASA ≥ IV, advanced renal\u002Fhepatic impairment, eating disorder)\n* BMI \\\u003C 18.5 kg\u002Fm² (underweight)\n* Concurrent participation in another interventional drug or device trial\n* Pregnancy or breastfeeding","ALL","18 Years","75 Years",{"count":21,"type":22},130,"ESTIMATED","INTERVENTIONAL",[25],"NA","Postoperative complications occur in 5-15% of patients undergoing elective primary total hip arthroplasty (THA), including periprosthetic joint infection (PJI), thrombosis, wound healing disorders, and metabolic dysregulation. The gut microbiome and the systemic immune profile have both been implicated as modifiable contributors to perioperative complication risk. Preoperative therapeutic fasting has been shown to remodel the gut microbiome, lower proinflammatory cytokines, and improve metabolic parameters.\n\nThis single-center, prospective, randomized, two-arm controlled trial at Charité - Universitätsmedizin Berlin investigates whether a structured 20-day preoperative fasting intervention (alternating cycles of the Buchinger Fastenbox and intermittent fasting) modulates two co-primary endpoints - plasma IL-8 (a central proinflammatory marker) and gut microbial alpha-diversity (Shannon index) - compared with standard preoperative care. Secondary endpoints include further immune markers (TNFα, IL-10, T-\u002FB-\u002FNK-cell subsets, activation\u002Fexhaustion markers, monocyte HLA-DR), microbiome composition and function, continuous glucose-monitoring and daily metabolic measures, patient-reported outcomes (HOOS, PROMIS-33, infection self-report), and clinical outcomes (postoperative complications per EBJIS criteria, length of stay).\n\nAdults aged 18-75 undergoing elective primary THA are stratified by metabolic status (metabolically healthy vs. metabolically unhealthy according to harmonized metabolic-syndrome criteria) and randomized 1:1 to the fasting intervention versus standard care. Stool and whole-blood samples are collected at baseline (Day -21), and at Day +7 post-operatively for shotgun-metagenomic sequencing and multiparameter flow cytometry, with additional cytokine blood samples at Day -1 and 6 h \u002F 24 h \u002F 72 h post-operatively. Continuous glucose monitoring is performed in all participants from Day -21 until surgery. Planned enrollment is 130 participants.",[28,29,30,31,32],"Hip Osteoarthritis","Arthroplasty, Replacement, Hip","Postoperative Complications","Surgical Wound Infection","Gastrointestinal Microbiome",[34,35,36,37,38,39,40,41,42],"Therapeutic fasting","Buchinger fasting","Intermittent fasting","Gut microbiome","Immunophenotyping","Continuous glucose monitoring","Total hip arthroplasty","Metabolic syndrome","Preoperative optimization","RECRUITING","2026-06-17",{"date":46,"type":47},"2026-06-22","ACTUAL",{"date":49,"type":47},"2025-07-01",{"date":51,"type":22},"2026-12-31",{"name":53,"class":54},"Charite University, Berlin, Germany","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":69,"conditions":70,"keywords":77,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":55},"100492429","phase-1-coffee-and-metabolites-modulating-the-gut-microbiome-in-colorectal-cancer-100492429","NCT05692024","COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER","COMMENCER: COffee and Metabolites Modulating the Gut MicrobiomE in Colorectal caNCER","COMMENCER","Inclusion Criteria:\n\nParticipants must meet the following criteria on screening examination to be eligible to participate in the study:\n\n* Participants must have histologically confirmed stage I, II, or III colon or rectal adenocarcinoma and have completed standard treatment (including surgery, chemotherapy and radiotherapy) at least 2 months ago.\n* Age 18 years or older.\n* This study will only include adult participants because colorectal carcinogenesis in children is more likely to be related to a cancer predisposition syndrome with distinct biological mechanisms compared with sporadic colorectal cancer in adults.\n* The effects of coffee on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n* Subjects must be able and willing to follow study procedures and instructions.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nParticipants who exhibit any of the following conditions at screening will not be eligible for admission into the study.\n\n* Participants who are receiving any other investigational agents.\n* Concurrent use of other anti-cancer therapy, including chemotherapy agents, targeted agents, biological agents, immunotherapy, or investigational agents not otherwise specified in this protocol.\n* Regularly consuming more than 2 cups of coffee ( 8 oz) per day for at least 3 days a week in the past month.\n* Current or recent use (within 1 month) of any coffee supplements (e.g., green coffee extracts).\n* History of diagnosed conditions that may be worsen by coffee, including arrhythmias, insomnia, tremors, tics, generalized anxiety disorder, bipolar disease, panic attacks, Tourette's, epilepsy or overactive bladder.\n* History of adverse reactions to coffee or intolerance of coffee consumption.\n* Inability or unwillingness to swallow capsules.\n* History of malabsorption or uncontrolled vomiting or diarrhea, or any other disease that could interfere with absorption of oral medications.\n* Any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that, in the opinion of the investigator, may increase the risks associated with study participation or study treatment, limit compliance with study requirements, or interfere with the interpretation of study results.\n* Pregnant or breastfeeding. The effects of coffee on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.\n\nShould a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Similarly, lactating women are excluded from this study because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with coffee. Consequently, breastfeeding should be discontinued if the mother is enrolled on the study.\n\n* Presence of synchronous (at the same time) malignancy for which the patient is currently receiving active treatment.\n* Known positive test for human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.",{"count":65,"type":22},80,[67,68],"PHASE1","PHASE2","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.",[71,72,32,73,74,75,76],"Colorectal Cancer","Coffee","Stenosis","Fibrosis, Liver","Ultrasound Elastography","Proton Magnetic Resonance Spectroscopy",[78,37,79,72,80],"Liver fat","Colorectal cancer","Tumor biopsy","2026-04-29",{"date":83,"type":47},"2026-05-05",{"date":85,"type":47},"2024-03-21",{"date":87,"type":22},"2028-08-31",{"name":89,"class":54},"Massachusetts General Hospital",{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":100,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":55},"100577744","smart-underwear-to-measure-diet-induced-hydrogen-sulfide-production-100577744","NCT06802276","Smart Underwear to Measure Diet-Induced Hydrogen Sulfide Production","Employing Smart Underwear to Measure Gut Microbial Hydrogen Sulfide Production","The inclusion\u002Fexclusion criteria will identify generally healthy volunteers that are able to ingest the intervention diets. Exclusion criteria based on diseases, medications, allergies, and specific dietary requirements will minimize the risks of adverse reactions to the intervention diets.\n\nInclusion Criteria:\n\n* Generally healthy volunteers defined as having no major known health conditions (e.g., diabetes, cancer, hypertension, etc.).\n* Normal bowel movements, with approximately 1 bowel movement reported per day\n* Willing to discuss flatus\n* Ages \\>18yrs\n* Willing to complete the entire study protocol, i.e. eating all of the food that is provided and completing all required measurements.\n\nExclusion Criteria:\n\n* Self-report or other evidence of diabetes, other endocrine\u002Fmetabolic abnormality, dyslipidemia, morbid obesity, severe hypertension, chronic kidney disease, liver disease, pulmonary disease, gastrointestinal, and cardiovascular diseases\n* Chronic medications for any of the above conditions\n* Food allergy that interferes with ability to complete the study\n* Food preferences, intolerance, or dietary requirements that would interfere with diet adherence\n* Planned dietary changes during the study period\n* Lack of appropriate food refrigeration and preparation equipment (e.g.- oven or microwave)\n* Pregnancy or planned pregnancy in the next month\n* Physical measurements: BMI \\> 35 kg\u002Fm2",true,{"count":99,"type":22},25,[25],"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.",[103,32],"Hydrogen Sulfide",[103,105,106,107,108],"H2S","Diet","Cysteine","Gut Microbiome","2026-04-27",{"date":81,"type":47},{"date":112,"type":47},"2025-05-21",{"date":114,"type":22},"2027-06-30",{"name":116,"class":54},"University of Colorado, Denver",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":17,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":23,"phases":129,"briefSummary":130,"conditions":131,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":55},"100532002","microbiome-and-diet-in-parkinsons-disease-100532002","NCT06207136","Microbiome and Diet in Parkinson's Disease","Canadian Parkinson's Microbiome Initiative: A Pilot Phase 2 Feasibility Randomized Controlled Trial of the MIND Diet in Parkinson's Disease","PD-Diet","Inclusion Criteria:\n\nEligible if the person living with Parkinson's has\u002Fis:\n\n1. a clinical diagnosis of PD,\n2. cognitively stable (no clinical dementia),\n3. between 40-80 years old,\n4. able to travel to UBC for 6 onsite visits over 18 months,\n5. sufficient English proficiency (coaching and cooking classes are in English only),\n6. on a stable dopaminergic medication for at least one month before baseline,\n7. computer and internet access at home, and can be available via video link for at least 80% of the study sessions.\n\nExclusion Criteria:\n\nNot eligible, if person has\u002Fis:\n\n1. a diagnosis of atypical parkinsonism,\n2. medical or psychiatric conditions that would prevent full participation in the nutrition intervention (such as food allergies), significant dysphagia, diabetes on insulin, anti-coagulation on warfarin, and inflammatory bowel disease,\n3. clinical dementia,\n4. unable to complete questionnaires or understand study instructions,\n5. using of immunomodulatory agents,\n6. used Probiotics in the last 4 weeks prior to study start,\n7. used Antibiotics in the last 3 months prior to study start,\n8. contraindications for MRI.","40 Years","80 Years",{"count":128,"type":22},40,[25],"The goal of this pilot study is to examine the feasibility and effects of an 18-month intervention diet compared to an active control diet (standard diet) in those living with Parkinson's Disease (PD), without dementia.\n\nResearch has shown that eating components of Mediterranean diets are associated with a 30% lower risk to develop PD and a 40% lower mortality rate in those living with PD. Diet may influence the gut and microbiomes, thus may affect PD risk and progression.\n\nThis study will examine how easy it will be to adhere to a certain type of diet for 18 months and what changes may occur in the gut microbiome and in PD symptoms on a specific diet during that time.\n\nThe study will involve in-person study visits at UBC as well as online diet coaching sessions and online group cooking classes over Zoom.\n\nThis is a randomized study, meaning that participants will be assigned by chance to either the Mediterranean-style diet group or the standard diet group for the duration of the 18 months.\n\nThis pilot study will also examine recruitment rates and retention, in order to prepare for a larger future study.",[132,133,108,32],"Parkinson Disease","Diet, Healthy","2026-03-19",{"date":136,"type":47},"2026-03-23",{"date":138,"type":47},"2024-12-03",{"date":140,"type":22},"2027-12-31",{"name":142,"class":54},"University of British Columbia",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":55},"100626613","a-randomized-triple-blind-placebo-controlled-study-to-evaluate-the-effects-of-a-supplement-on-nutrient-gaps-and-gut-health-among-individuals-utilizing-glp-1-ras-100626613","NCT07437911","A Randomized, Triple-blind, Placebo-controlled Study to Evaluate the Effects of a Supplement on Nutrient Gaps and Gut Health Among Individuals Utilizing GLP-1 RAs","Inclusion Criteria:\n\n* Be male or female\n* Be aged 18-59.\n* Has a BMI between 20-31.9.\n* Anyone currently taking GLP-1 medication at their maintenance dose (week 8+), and without any plans to alter their dosage. This includes: Semaglutide (Ozempic®, Wegovy®, Rybelsus®), Liraglutide (Saxenda®, Victoza®), Dulaglutide (Trulicity®), Exenatide (Byetta®, Bydureon®), Lixisenatide (Adlyxin®)\n* Anyone willing to follow the study protocol, including immediately prior to the all blood tests, duplicating their diet for 72 hours (3 days), refraining from caffeine and exercise for 24 hours, and fasting for 10 hours.\n* Anyone willing to maintain their current diet, sleep pattern, and activity levels for the duration of the trial.\n* Anyone willing to avoid introducing any other supplements, medications, or herbal remedies for the duration of this trial.\n* Anyone who is generally healthy - does not live with any diagnosed uncontrolled chronic disease.\n* Has access to a consistent weighing scale for the duration of the study.\n* Resides in the United States.\n\nExclusion Criteria:\n\n* Anyone with a diagnosis of Type I or Type II diabetes.\n* Anyone with a diagnosis of any metabolic health condition, such as hypertension and dyslipidemia.\n* Anyone who has taken any multivitamin\u002Fmultimineral supplements within the past 3 months.\n* Anyone who has taken a probiotic supplement within the past month.\n* Anyone who has regularly consumed (5 days\u002Fweek or more) products that target healthy aging, anti-aging, longevity, gut health, energy, or ingestive behaviour (such as cravings), including resveratrol, quercetin, pterostilbene, coQ10, grapefruit, nicotinamide riboside, prebiotic fiber, green tea, niacin (vitamin B3) within the past 2 months.\n* Anyone who has received an antibiotic, antifungal, antiparasitic, or antiviral treatment within the past 90 days.\n* Anyone who has a known history of severe digestive disorders or metabolic conditions that impact nutrient absorption or metabolism, including acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, a history of colon resection, gastroparesis, Inborn errors of metabolism (such as PKU), or gastrointestinal tract surgeries.\n* Anyone with any known allergies or hypersensitivities to any supplement product ingredients.\n* Anyone with any chronic health conditions that could impact participation in this study, such as asthma, gout, fibromyalgia, chronic inflammatory conditions (such as Crohn's, Lupus, HIV\u002FAIDS), thyroid conditions, cancer (within the past 5 years), mental health disorders, history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period.\n* Anyone currently pregnant, trying to conceive, or breastfeeding.\n* Anyone who has undergone a change in hormone therapy (including oral contraceptives) within the past 4 weeks, or is unwilling to maintain their current hormone therapy\u002Foral contraceptive use throughout the course of the study.\n* Anyone who consumes more than 2 standard alcoholic drinks per day or more than 10 drinks per week, or has within the past 6 months.\n* Anyone who is currently a smoker or has been a smoker within the past month.\n* Anyone who follows a specific exclusion diet, including vegan, vegetarian, carnivore, paleo, atkins, or ketogenic.","59 Years",{"count":151,"type":22},120,[25],"This study is a triple-blind, placebo-controlled, randomized controlled trial of 120 adults that will evaluate the impact of a novel nutritional supplement on improving nutrient gaps and changing nutrient status and the gut microbiome among glucagon-like peptide-1 receptor agonist (GLP-1 RA) users.",[155,156,32,157],"Nutrition Intake","Nutrition Status","GLP-1","2026-02-24",{"date":160,"type":47},"2026-02-27",{"date":162,"type":22},"2026-02",{"date":164,"type":22},"2026-08",{"name":166,"class":167},"Athletic Greens International","INDUSTRY",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":55},"100543741","clinical-characteristics-of-sleep-disorders-in-patients-with-ulcerative-colitis-100543741","NCT06359808","Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis","A Study Based on the Microbiota-gut-brain Axis to Explore the Clinical Characteristics of Sleep Disorders in Patients With Ulcerative Colitis","Inclusion Criteria:\n\n* Ulcerative colitis was diagnosed according to the Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018);\n* Complete medical records and signed informed consent.\n\nExclusion Criteria:\n\n* Previous mental illness or taking anti-anxiety and depression drugs;\n* Patients with malignant tumors of digestive system or serious diseases of organs such as heart, lung, liver and kidney function damage or diseases of blood system;\n* Drugs that affect heart rate or autonomic nervous function, such as glucocorticoids, beta-blockers, calcium channel blockers, etc. have been taken within the last 2 weeks;\n* People who smoke, drink alcohol, drink tea, and drink coffee within 24 hours (all stimulants, which can easily lead to excitement and affect heart rate variability);\n* Other diseases associated with autonomic nervous dysfunction (such as hyperthyroidism, hypertension, atrial premature beat, ventricular premature beat, pre-excitation syndrome, left bundle branch block, right bundle branch block, etc.).","65 Years",{"count":177,"type":22},152,"OBSERVATIONAL","Ulcerative colitis(UC) is one of the two main forms of inflammatory bowel disease(IBD), which seriously affects the quality of life of patients. Previous studies have demonstrated that more than 60% of IBD patients have sleep disorders, which is emerging as an important risk factor for disease recurrence and poor prognosis. However, the mechanisms by which sleep disorders regulates the occurrence and development of IBD remain undefined. This study aims to explore the clinical characteristics of ulcerative colitis patients with sleep disorders based on the microbiota-gut-brain axis, to analyze the effects of sleep disorders on autonomic nervous function, gut microbiota, and metabolites in UC patients.",[181,182,32,183],"Colitis, Ulcerative","Sleep Quality","Autonomic Nervous System Imbalance","2025-12-25",{"date":186,"type":47},"2025-12-31",{"date":188,"type":47},"2024-04-01",{"date":190,"type":22},"2026-06-30",{"name":192,"class":54},"Xijing Hospital",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":97,"sex":17,"minAge":200,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":55},"100308670","phase-1-vaginal-microbiome-seeding-and-health-outcomes-in-cesarean-delivered-neonates-100308670","NCT03298334","Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates.","Vaginal Microbiome Seeding and Health Outcomes in Cesarean-delivered Neonates: a Randomized Controlled Trial","Inclusion Criteria for Mother:\n\n* Scheduled for cesarean delivery at ≥ 37 weeks\n* Pregnant with single fetus, in good general health, age 18 years or older\n* Negative maternal testing for infections transmitted through vaginal and\u002For other body fluids performed as standard of care tests in early pregnancy\n* Negative testing for Group B strep at 35-37 weeks gestation\n* Vaginal pH ≤ 4.5 indicative of Lactobacillus-dominated vaginal microbiota\n* No maternal or fetal complications that may inhibit the ability to perform microbiome restoration per protocol\n* English or Spanish speaking\n* Negative maternal testing for Gonorrhea, Chlamydia, Hepatitis B, Hepatitis C, Syphilis, and HIV at 35 weeks gestation or later\n* Women aged 18-29 years must have a normal Pap test within 3 years\n* Women aged 30-65 years must have a normal Pap test and an HPV test (co-testing) within 5 years or FDA-approved primary hrHPV testing alone within 5 years or a normal Pap test alone within 3 years\n* Negative maternal testing for SARS-CoV-2 for the delivery admission performed as standard of care test at the Inova Health System.\n\nInclusion Criteria for Infant:\n\n* Infant condition after delivery requires no more than standard neonatal resuscitation\\* or is otherwise medically unable to receive the full VMT procedure\n\n\\[\\*\\] Standard neonatal resuscitation may include: tactile stimulation, bulb suction, oxygen without positive pressure, or drying\n\nExclusion Criteria for Mother:\n\n* Delivery at a hospital other than Inova Health System\n* Cesarean delivery scheduled for active infection that would have interfered with vaginal delivery such as genital herpetic lesions\n* Rupture of membranes prior to scheduled cesarean delivery\n* Bacterial vaginosis within 30 days of cesarean delivery\n* Symptomatic urinary tract infection within 30 days of cesarean delivery\n* Antibiotic therapy within 30 days of cesarean delivery (exclusive of medication use for prophylaxis at the time of surgery)\n* Symptoms on admission suggesting Chorioamnionitis, e.g. maternal fever, fundal tenderness\n* Symptoms on delivery admission of possible vaginal infection such as genital herpetic lesions\n* History of genital HSV\n* History positive testing for Group B strep infection\n* History of a child with a diagnosis of Group B strep sepsis\n* Pregnancy a result of donor egg or surrogacy\n* Preexisting history of Type I or Type II Diabetes\n* Maternal history of documented genital HPV infection, positive HPV testing or genital warts on physician examination\n* Positive maternal testing for SARS-CoV-2 within 30 days of delivery or symptoms on admission suggesting potential Covid-19 infection","0 Days","50 Years",{"count":203,"type":22},600,[67,68],"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.",[207,208,209,210,211,32],"Cesarean Delivery Affecting Newborn","Obesity, Childhood","Intestinal Microbiome","Microbiota","Host Microbial Interactions","2025-06-04",{"date":214,"type":47},"2025-06-08",{"date":216,"type":47},"2018-07-01",{"date":218,"type":22},"2029-04",{"name":220,"class":221},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":231,"conditions":232,"keywords":241,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":55},"100390125","a-study-to-explore-the-role-of-gut-flora-in-covid-19-infection-100390125","NCT04359836","A Study to Explore the Role of Gut Flora in COVID-19 Infection","A Non-Interventional Pilot Study to Explore the Role of Gut Flora in COVID-19 Infection","Inclusion Criteria:\n\n1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study\n2. Male or female of 18 years of age or older\n3. Diagnosis of COVID-19 infection by RT- PCR within 1 week of Screening\n\nExclusion Criteria:\n\n1. Refusal to sign informed consent form\n2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.\n3. Postoperative stoma, ostomy, or ileoanal pouch\n4. Treatment with total parenteral nutrition",{"count":230,"type":22},250,"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.",[108,32,233,234,235,236,237,238,239,240],"COVID","COVID-19","Corona Virus Infection","Coronavirus","Coronaviridae Infections","Coronavirus 19","Coronavirus-19","COVID 19",[242,236,243,244,233,234],"Microbiome","Corona Virus","19","2025-06-02",{"date":247,"type":47},"2025-06-05",{"date":249,"type":47},"2020-04-16",{"date":251,"type":22},"2027-07-31",{"name":253,"class":54},"ProgenaBiome",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":261,"targetDuration":4,"studyType":23,"phases":263,"briefSummary":264,"conditions":265,"keywords":268,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"100531904","phase-2-efficacy-and-safety-of-fecal-microbiota-transplantation-fmt-in-reducing-recurrence-of-colorectal-adenoma-cra-100531904","NCT06205862","Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Reducing Recurrence of Colorectal Adenoma (CRA)","Efficacy and Safety of Fecal Microbiota Transplantation in Reducing Recurrence of Colorectal Adenomas After Endoscopic Resection: a Multicenter, Open-label, Randomized Controlled Study","Inclusion Criteria:\n\n1. Age 18-75, gender not specified.\n2. Colorectal adenoma patients diagnosed by colonoscopy and treated with endoscopic resection (such as EMR, ESD, APC treatment, etc.)，or patients who have undergone endoscopic resection within the past 6 months and have pathologically confirmed colorectal adenoma.\n3. Individuals who are able to swallow pills\u002Fcapsules.\n4. Individuals who voluntarily sign an informed consent form after fully understanding the purpose and procedures of this study, the characteristics of the disease, the therapeutic efficacy of the drugs, the related examination methods, and the potential risks\u002Fbenefits of the study.\n\nExclusion Criteria:\n\n1. Individuals in whom the adenoma was not completely removed in a previous colonoscopy;\n2. Individuals who experienced serious complications during or after adenoma resection, including perforation, uncontrollable bleeding, or severe infection;\n3. Individuals with a history of familial adenomatous polyposis (FAP) or hereditary nonpolyposis colorectal cancer (HNPCC\u002FLynch syndrome);\n4. Individuals regularly taking aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase 2 (COX2) inhibitors, calcium, or vitamin D;\n5. Individuals with a history of subtotal or total gastrectomy or partial bowel resection;\n6. People who cannot tolerate colonoscopy;\n7. Individuals with allergic diathesis, known allergies to fecal microbiota transplantation, drug allergies, or intolerance;\n8. Individuals with serious heart, liver, or kidney diseases, or any history of cancer;\n9. People suffering from severe constipation;\n10. Pregnant women, breastfeeding mothers, or women planning to become pregnant;\n11. Patients with mental illness who are unable to cooperate;\n12. Individuals involved in the design, planning, or execution of this trial;\n13. Any other individuals who, in the investigator's opinion, are unsuitable for inclusion.",{"count":262,"type":22},466,[68],"The goal of this clinical trial is to learn about the efficacy and safety of fecal microbiota transplantation in reducing recurrence of colorectal adenomas after endoscopic resection.\n\nThe main questions it aims to answer are:\n\n* the efficacy and safety of fecal microbiota transplantation in reducing the recurrence rate of colorectal adenomas after endoscopic resection.\n* changes in the intestinal and mucosal microbiota of patients before and after endoscopic treatment.\n* changes in the intestinal and mucosal microbiota of patients before and after fecal microbiota transplantation.\n\nParticipants are required to complete one colonoscopy and infuse 150ml of fecal suspension into the terminal ileum under endoscopy, performing the first fecal microbiota transplantation (FMT) on day 0. Subsequently, for 2 days continuously (day 1-2), the participants will undergo microbiota transplantation in the form of oral capsules, taking 40 FMT capsules within one day (20 capsules bid). Subsequently, participants will receive a maintenance treatment with oral FMT capsules (20 capsules bid) at 3, 6, and 9 months (approximately every 75 to 90 days). Participants will undergo their first follow-up colonoscopy between 6 to 12 months(the high-risk adenoma group will receive colonoscopy at 6 months, and the low-risk adenoma group will receive colonoscopy at 12 months).",[266,267,32],"Fecal Microbiota Transplantation","Colorectal Adenoma",[266,269,32,270],"Colorectal Adenomas","Recurrence rate after endoscopic resection","2024-07-12",{"date":273,"type":47},"2024-07-15",{"date":275,"type":47},"2024-04-09",{"date":277,"type":22},"2028-12",{"name":279,"class":54},"Shenzhen Hospital of Southern Medical University",5,{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":178,"phases":4,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":296,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":4},"100517745","involvement-of-the-gut-microbiota-in-calcified-aortic-stenosis-100517745","NCT06021535","Involvement of the Gut Microbiota in Calcified Aortic Stenosis","Involvement of the Gut Microbiota and Its Metabolites in the Pathophysiology of Calcified Aortic Stenosis","Gut-CAS","Inclusion Criteria:\n\n* Group of patients with CAS:\n* Calcified aortic stenosis diagnosed on a cardiac ultrasound or CT not older than 3 months\n* Severe aortic stenosis: surgical indication based on symptoms and ultrasound data (high gradient aortic stenosis : Vmax\\> 4m\u002Fs, mean gradient \\> 40mmHg, area \\\u003C 1cm², low flow low-gradient CAS: left ventricular ejection fraction (LVEF) \\\u003C 40%, Vmax\\\u003C 4m\u002Fs, mean gradient \\\u003C 40mmHg, area \\\u003C 1cm², paradoxical low-gradient CAS: LVEF \\> 55%, Vmax\\\u003C 4m\u002Fs, mean gradient \\\u003C 40mmHg, area \\\u003C 1cm²)\n* Moderate CAS: 3m\u002Fs \\\u003CVmax\\\u003C 4m\u002Fs, 20mmHg \\\u003C mean gradient \\\u003C 40mmHg\n* Mild CAS: 2,6m\u002Fs \\\u003C Vmax \\\u003C 2.9m\u002Fs, mean gradient \\\u003C 20mmHg\n* Aortic sclerosis: calcified remodeling of the aortic valve visible on ultrasound or CT.\n\nControl group - free of CAS:\n\n\\- No calcified aortic stenosis verified on a cardiac ultrasound or CT not older than 3 months\n\nExclusion Criteria:\n\n* Treatment interfering with the composition of the intestinal microbiota: local or systemic corticosteroids within the last 3 months, antibiotics within the last 3 months, antiretrovirals, bile acid chelators (questran and colesevelam), HIV-targeted antiretroviral therapies, selective serotonin reuptake inhibitor-type antidepressants\n* Clinical criteria: history of cholecystectomy, documented chronic liver disease in the patient, failure to fast on the day of the blood test, inflammatory bowel disease\n* Patients requiring emergency intervention (myocardial infarction, acute aortic or mitral insufficiency, cardiogenic shock).\n* AS of rheumatic origin, infective endocarditis.","90 Years",{"count":291,"type":22},100,"Calcific aortic stenosis (CAS) is a disease characterized by progressive calcification of the aortic valve, obstructing the passage of blood from the left ventricle into the general circulation. It is the most frequent cause of valve disease in the elderly. To date, no means of preventing the disease has been discovered, and the only treatment available is valve replacement during cardiac surgery, or percutaneous implantation of a valve prosthesis when the narrowing becomes severe and causes symptoms.\n\nThe intestinal flora or microbiota, the reservoir of all the microorganisms in the gut, is implicated in numerous diseases, particularly of the intestine. But to date, no study has established a link between CAS and microbiota. The intestinal microbiota acts through molecules produced by itself or the host and passing into the bloodstream. In the pathophysiology of CAS, the valve leaflets are breached and do not heal. These molecules can enter and have beneficial or deleterious effects, in particular promoting calcification of aortic valve cells.\n\nConcrete objectives:\n\nImprove understanding of calcific aortic stenosis in humans Study the composition of intestinal flora in patients with aortic stenosis and compare it with healthy subjects Study the molecules in the intestinal flora likely to be involved in the development of aortic stenosis in humans.",[294,32,295],"Aortic Stenosis","Metabolomics","NOT_YET_RECRUITING","2023-08-29",{"date":299,"type":47},"2023-09-01",{"date":301,"type":22},"2024-01-01",{"date":303,"type":22},"2028-12-31",{"name":305,"class":54},"Insel Gruppe AG, University Hospital Bern",{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":314,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":317,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":55},"100462875","cancer-associated-muscle-mass---molecular-factors-and-exercise-mechanisms-100462875","NCT05307367","Cancer-associated Muscle Mass - Molecular Factors and Exercise Mechanisms","Identifying Molecular Factors Contributing to Cancer-associated Muscle Mass Loss and Providing Clinical Evidence for Exercise Mechanisms to Functionally Restore Muscle in Cancer","PANACEA","Inclusion Criteria, WP1+WP2X+WP2:\n\n* Men and women at or above the age of 18\n* Histological and radiological verified NSCLC (both squamous and adenocarcinoma) st. IIIb\u002FIV stage not eligible to concurrent chemo\u002Fradiation therapy as primary treatment\n* Referred for 1st line palliative anticancer therapy (platin based, immunotherapy, combined therapy or TKI), this goes for WP1 + WP2\n* Referred for palliative anticancer therapy (platin based, immunotherapy, combined therapy or TKI), for recurrent cancer, this goes only for WP2X.\n* Having a staging\u002Fbaseline CT within 4 weeks of initiation of treatment (PET\u002FCT are also allowed), or a baseline scan planned within the first week of treatment.\n* ECOG Performance Status 0-2\n* Having signed the informed consent form\n\nExclusion Criteria, WP1+WP2X+WP2:\n\n* Any other known malignancy requiring active treatment (prior cancer diagnosis is not some exclusion criteria if oncology-treatment is completed)\n* Local palliative radiotherapy as primary treatment\n* ECOG Performance status \\> 2\n* Physical disabilities excluding physical testing\n* Inability to understand Danish\n* Inability to understand scoring systems\u002Fpatient-reported outcome measures\n\nInclusion Criteria, WP3:\n\n* Men and women above the age of 18\n* Histological and radiological verified NSCLC (both squamous and adenocarcinoma) st. IIIb\u002FIV stage\n* ECOG Performance Status 0-2\n* Having signed the informed consent form.\n\nExclusion Criteria, WP3:\n\n* Any other known malignancy requiring active treatment (prior cancer diagnosis is not some exclusion criteria if oncology-treatment is completed)\n* ECOG Performance Status \\> 2\n* Physical disabilities excluding physical testing\n* Inability to understand Danish\n* Inability to understand scoring systems\u002Fpatient-reported outcome measures","100 Years",{"count":316,"type":22},144,[25],"Muscle mass loss is a common adverse effect of cancer. Muscle mass loss occurs with or without reduction in body weight. Cancer cachexia (CC) is the involuntary loss of body weight of \\>5% within 6 months and it occurs in 50-80% of patients with metastatic cancer.\n\nIt is estimated that CC is a direct cause of up to 30% of all cancer-related deaths. No treatment currently is available to prevent CC, likely because the chemical reactions that causes of this devastating phenomenon in unknown.\n\nNo treatment currently is available to prevent muscle mass loss in patients with cancer but is urgently needed as the reduced muscle mass and function is associated with impaired physical function, reduced tolerance to anticancer therapy, poor quality of life (QoL), and reduced survival. There is evidence of an interdependence between informal caregiver (e.g. spouse) and patient QoL. Thus, identifying caregiver distress and needs can potentially benefit QoL for patients with cancer cachexia. Despite the enormous impact on disease outcomes, it is not known why the loss of muscle mass and function occurs and very few studies have investigated the underlying molecular causes in humans. In particular, there is a severe lack of studies that have obtained human skeletal muscle and adipose tissue sample material. Such reference sample materials will be invaluable to obtaining in-depth molecular information about the underlying molecular causes of the involuntary but common muscle mass and fat mass loss in cancer.\n\nAt a whole body level, cancer cachexia is associated with reduced sensitivity to the hormone insulin, high levels of lipids in the blood, and inflammation. Within the skeletal muscle, the muscle mass loss is associated with elevated protein breakdown and reduced protein build-up while emerging, yet, limited data also suggest malfunction of the power plants of the cells called mitochondrions. The role of malnutrition and how it contributes to weight loss is understood only to the extent of the observed loss of appetite and the reduced food intake because of pain, nausea, candidiasis of the mouth, and breathlessness. Evidence is increasing that the environment of the intestinal system could be implicated in cancer cachexia, yet, the possible effect of cancer and the cancer treatment on the intestinal environment is not understood. Thus, large and as yet poorly understood details of this syndrome precede a later weight loss.\n\nExercise training could help restore muscle function and how the chemical reactions works in cancer. In healthy people, and patients with diabetes, cardiovascular disease, and obesity exercise potently improves health. Exercise has been thought to slow down the unwanted effects of cancer cachexia by changing the reactions mentioned above. Thus, there is a tremendous gap in our knowledge of how and if exercise can restore the cells power plants function, muscle mass, strength, and hormone sensitivity in human cachexic skeletal muscle. Tackling that problem and examining potential mechanisms, will enable us to harness the benefits of exercise for optimizing the treatment of patients with cancer.\n\nThe data will provide novel clinical knowledge on cachexia in cancer and therefore addressing a fundamental societal problem.\n\nThree specific aims will be addressed in corresponding work packages (WPs):\n\n* investigate the involvement of hormone sensitivity of insulin and measure the chemical reactions between the cells in patients with lung cancer (NSCLC) and describe the physical performance and measure amount of e.g. muscles and adipose tissue across the 1st type of cancer treatment and understand how that is related to the disease and how patients and informal caregiver feel (WP1).\n* find changes in the chemical reactions in skeletal muscle, adipose tissue (AT), and blood samples in these patients, to understand how to predict how the disease will develop (WP2).\n* measure changes of skeletal muscle tissue in response to exercise and see if it might reverse the hormone insensitivity and improve muscle signaling and function (WP3).\n\nThe investigators believe that:\n\n* the majority of patients with advanced lung cancer, at the time of diagnosis already are in a cachectic state, where they lose appetite, and have hormonal changes, and an overall altered chemical actions between the cells affecting both muscle mass and AT. The investigators propose that all this can predict how the disease will progress, and how patient- and informal caregiver fell and how they rate their quality of life.\n* lung cancer and the treatment thereof is linked with changes in the blood, the muscle tissues, and the adipose tissues, especially in patients experiencing cachexia, that could be targeted to develop new treatment.\n* exercise can restore the muscles and improve insulin sensitivity and improve the function of the cells power plants in patients with lung cancer-associated muscle problems.",[320,321,322,323,324,325,326,327,328,329,330,331,332,32,333,334,335,336],"Cachexia","Neoplasms","Exercise","Metabolism","Body Composition","Insulin Resistance","Physical Functional Performance","Quality of Life","Sarcopenia","Caregivers","Adipose Tissue","Muscle, Skeletal","Patient Reported Outcome Measures","Proteomics","Lipidomics","Epigenomics","Mitochondria","2022-05-09",{"date":339,"type":47},"2022-05-16",{"date":341,"type":47},"2022-04-01",{"date":343,"type":22},"2028-01-01",{"name":345,"class":54},"University of Copenhagen",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":97,"sex":17,"minAge":353,"maxAge":175,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":355,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":296,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":55},"100467282","effect-of-prebiotics-on-blood-pressure-management-100467282","NCT05364736","Effect of Prebiotics on Blood Pressure Management","An Interventional Study for the Effects of Highland Barley β-glucan on the Management of Hypertension and Cardiovascular Risk","Inclusion Criteria:\n\n1. Age:30-65 years old\n2. Newly diagnosed hypertension did not use antihypertensive drugs OR Systolic blood pressure ≥140mmHg on the physical examination OR Diastolic blood pressure ≥90mmHg on the physical examination.\n3. BMI≥18 kg\u002Fm2\n\nExclusion Criteria:\n\n1. Receiving or have been treated with antihypertensive drugs.\n2. Complications including cardiovascular and cerebrovascular diseases such as coronary heart disease and stroke.\n3. Severe liver or renal insufficiency (alanine aminotransferase, aspartate aminotransferase or alkaline phosphatase is greater than 3 times the upper limit of normal OR GFR\\\u003C30ml\u002Fmin\u002F1.73m2).\n4. Autoimmune diseases or thyroid diseases.\n5. Women who are pregnant, nursing, or prepare to give birth during the trail.\n6. Malignant disease, infectious disease, inflammatory disease and advanced liver disease.\n7. Mental or intellectual abnormalities, unable to sign informed consent.\n8. Complications including chronic gastrointestinal disease; or suffered from acute gastrointestinal diseases within 1 months before screening visit.\n9. Received antibiotics, probiotics within 3 months before screening visit or throughout the trail.\n10. Major operations were performed within six months of screening visit, or will be made during the trial.\n11. Alcohol abuse (alcohol intake\\>60g\u002Fd for male and alcohol intake\\>40g\u002Fd for female)","30 Years",{"count":291,"type":22},[25],"This survey is designed to investigate the effect of highland barley β-glucan supplementation on the regulatory of blood pressure, gut microbiota and cardiovascular risk fators in subjects with hypertention.",[358,32],"Hypertension",[358,32,360],"Prebiotics","2022-05-03",{"date":363,"type":47},"2022-05-06",{"date":365,"type":22},"2022-10-17",{"date":367,"type":22},"2030-12-31",{"name":369,"class":54},"Sun Yat-sen University"]