[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intestinal-microbiome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intestinal-microbiome":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,72,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100308670","phase-1-vaginal-microbiome-seeding-and-health-outcomes-in-cesarean-delivered-neonates-100308670",false,"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",true,"ALL","0 Days","50 Years",{"count":21,"type":22},600,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","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.",[29,30,31,32,33,34],"Cesarean Delivery Affecting Newborn","Obesity, Childhood","Intestinal Microbiome","Microbiota","Host Microbial Interactions","Gastrointestinal Microbiome","RECRUITING","2025-06-04",{"date":38,"type":39},"2025-06-08","ACTUAL",{"date":41,"type":39},"2018-07-01",{"date":43,"type":22},"2029-04",{"name":45,"class":46},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100393973","phase-1-metabolic-and-metagenomic-effects-of-intestinal-microbiome-repopulation-in-unexplained-atherosclerosis-100393973","NCT04410003","Metabolic and Metagenomic Effects of Intestinal Microbiome Repopulation in Unexplained Atherosclerosis","Metabolic and Metagenomic Effects of Repopulation of the Intestinal Microbiome in Patients with Severe Unexplained Atherosclerosis","Inclusion Criteria:\n\n* Severe atherosclerosis, with total plaque area in the top quartile (\\>119 mm2), not explained by traditional risk factors in linear regression (residual score \\>= 2)\n\nExclusion Criteria:\n\n* Excluded will be patients unwilling\u002Funable to provide informed consent, unwilling to ingest the stool capsules at baseline, patients with moderate to severe renal failure (eGFR\\\u003C50), immunosuppressed patients, and patients with cancer, unstable angina, planned carotid revascularization or other conditions that might be expected to reduce their survival to \\\u003C 1 year (including age \\>80).","18 Years",{"count":57,"type":22},100,[25],"Patients with unexplained atherosclerosis (severe atherosclerosis not explained by traditional risk factors) will receive fecal microbial transplants (FMT) from patients with a Protected phenotype (patients who have high levels of risk factors but little or no carotid atherosclerosis). The objective is to determine what changes in the intestinal microbiome are associated with a decline in plasma levels of toxic metabolites of the itnestinal microbiome such as trimethylamine N-oxide (TMAO) and p-cresylsulfate. The intention is to develop an ecosystem therapeutic of cultured bacteria to treat atherosclerosis.",[61,31],"Atherosclerosis","2024-10-15",{"date":64,"type":39},"2024-10-17",{"date":66,"type":39},"2020-06-02",{"date":68,"type":22},"2025-07-30",{"name":70,"class":71},"Western University, Canada","OTHER",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":47},"100502342","phase-2-synbiotics-and-fecal-microbiota-transplantation-to-treat-non-alcoholic-steatohepatitis-100502342","NCT05821010","Synbiotics and Fecal Microbiota Transplantation to Treat Non-Alcoholic Steatohepatitis","SYNCH","Inclusion Criteria:\n\n* biopsy-proven NASH obtained up to 32 weeks before screening: SAF Steatosis score ≥1, Activity ≥2, Fibrosis \\\u003C4; 50% of participants should at least have NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on tandem reading of two expert liver pathologists\n* fluency in Dutch or English\n* participants should be able to understand the information and give informed consent\n\nExclusion Criteria:\n\n* Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before screening (significant alcohol consumption is defined as more than 2 international units\u002Fday for females and more than 3 international units\u002Fday for males, on average; 1 international unit contains ±14 grams of alcohol)\n* liver cirrhosis or hepatocellular carcinoma\n* hepatitis B and\u002For C\n* auto-immune hepatitis\n* Wilson's disease\n* primary sclerosing cholangitis\n* primary biliary cholangitis\n* alpha-1-antitripsine deficiency and hemochromatosis\n* history of liver transplant, current placement on a liver transplant list\n* use of pre-, pro- or synbiotics\n* use of systemic antibiotics 3 month prior to randomization\n* use of tamoxifen, methotrexate or amiodarone\n* prior or planned bariatric surgery\n* active GLP-1 receptor agonist treated diabetes mellitus\n* bleeding disorder\n* International normalized ratio (INR) of prothrombin time \\>1.4 or platelet count \\\u003C100 109\u002FL at screening\n* anti-platelet\u002Fcoagulant therapy use which cannot be temporarily discontinued\n* any major cardiovascular event within 6 months prior to screening (e.g. myocardial infarction, cerebrovascular accident)\n* prolonged compromised immunity (e.g. recent cytotoxic chemotherapy, HIV-infection with a CD4 count \\\u003C 240)\n* active or prior history of invasive malignancy (except for curatively treated in situ carcinomas \\[e.g., cervix\\] or non-melanoma skin cancer) unless a complete remission was achieved\n* surgery scheduled for the trial duration period, except for minor surgical procedures, in the opinion of the investigator\n* pregnant or nursing women\n* any condition which, in the investigator's opinion, might jeopardize participants' safety or compliance with the protocol\n* participation in another concomitant clinical trial.","75 Years",{"count":81,"type":22},48,[26],"The goal of this clinical trial is to investigate the therapeutic potential of A. soehngenii and pasteurized A. muciniphila combined with B. animalis subsp. lactis and fructo-oligosaccharides with and without conditioned vegan lyophilized fecal microbiota transplantation capsules to reduce NASH in patients with fibrotic NASH. The main questions to answer are:\n\n1. Can NASH be treated by altering the gut microbiota using LFMT capsules?\n2. Can NASH be treated using a syntrophic cocktail of synbiotics and will these strains strengthen the effect of FMT?\n3. What are the underlying mechanism by which the aforementioned treatments attenuate NASH?\n\nParticipants will be treated with FMT-capsules or placebo, and all participants will receive a cocktail of 3 strains of probiotics and one type of prebiotic.",[85,86,87,88,89,90,91,31,92],"Non Alcoholic Steatohepatitis","Non-Alcoholic Fatty Liver Disease","Fecal Microbiota Transplantation","FMT","Prebiotics","Probiotics","Microbiome","Gut Microbiome","2024-08-26",{"date":95,"type":39},"2024-08-27",{"date":97,"type":39},"2023-03-17",{"date":99,"type":22},"2026-08-20",{"name":101,"class":71},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":16,"sex":17,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":114,"phases":4,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100436241","limit-early-adiposity-rebound-in-children-100436241","NCT04960670","LIMIT Early Adiposity Rebound in Children","LIMIT (LIfestyle and Microbiome InTeraction) Early Adiposity Rebound in Children","LIMIT","* Inclusion criteria: i) Infants of both sexes born to vaginal\u002Fcaesarean delivery; ii) Gestational age: 37-42 weeks; iii) Italian-speaking parent; iv) 7 Ability of the parent\u002Fguardian to give informed consent; v) Ability of the mother to answer questionnaires.\n* Exclusion Criteria: i) Infants with genetic\u002Fcongenital diseases; ii) Infants selected for another clinical study; iii) Infants hospitalized immediately after birth; iv) Presence of gestational diabetes; v) Presence of hyperthyroidism during pregnancy; vi) Parents refusing to sign the informed consent.","1 Day","48 Months",{"count":113,"type":22},150,"OBSERVATIONAL","Childhood obesity is a strong predictor of adult obesity with health and economic consequences for the individual and society. Adiposity rebound (AR) is a rise in the Body Mass Index occurring between 3-7 years. Early adiposity rebound (EAR) occurs at a median age of 2 years and is a risk factor for later obesity. Events happening in \"the first 1,000 days\" play a role in obesity development. One of the key elements in this crucial time window is the gut microbiome, a highly dynamic organ that is sensitive to environmental exposure being linked to obesity development. Prenatal (dietary\u002Flifestyle maternal factors and environmental exposure) and postnatal determinants (the type of feeding, sleep patterns, speed of growth) and environmental obesogenic pollutants may influence the infant microbial colonization, thus increasing the risk of EAR onset.\n\nLIMIT will holistically identify the longitudinal interplay between the intestinal microbiome and infant\u002Fmaternal nutritional and lifestyle habits, environmental factors exposure and anthropometric measurements, in children with AR vs EAR, driving new mechanistic insights to create an EAR predictive model.\n\nThe study will evaluate a group of 150 mother-infant pairs, during the first four years of life at different follow-up.",[117,118,31],"Childhood Obesity","Life Style",[120,121,122,123,124,125,126,127,128,129],"childhood obesity","maternal lifestyle","gut microbiome","adiposity rebound","fetal programming","first thousand days","pregnancy","breastfeeding","children nutrition","endocrine disruptors chemicals","NOT_YET_RECRUITING","2021-07-01",{"date":133,"type":39},"2021-07-14",{"date":135,"type":22},"2021-12-01",{"date":137,"type":22},"2026-12-31",{"name":139,"class":71},"University of Pavia"]