[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microbiome-dysbiosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microbiome-dysbiosis":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,66,94,126,159,182,216],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":65},"100607502","phase-2-the-bloom-infant-probiotic-bip-study-100607502",false,"NCT07189390","The Bloom Infant Probiotic (BIP) Study","A Randomised Controlled Trial to Assess if a Probiotic Intervention Leads to Enhanced Immune Responses to Vaccination in Antibiotic-treated Infants (Bloom Infant Probiotic (BIP) Study)","BIP","Inclusion Criteria:\n\n1. Infants administered antibiotics in the first 28 days of life. Infants must have documented direct antibiotic exposure - defined as having received at least 36 hours of antibiotic treatment in the neonatal period (the first 28 days after birth).\n2. Gestational age ≥ 35 weeks.\n3. Birth weight ≥ 2500g.\n4. Mother aged at least 18 years and able and willing to provide written informed consent for themselves and their infant.\n5. Parent\u002Fguardian agrees to not give any other probiotics to their infant prior to vaccination at 6 weeks, including any formula that contains probiotics.\n6. Infant planning to receive all nationally approved vaccines during next 6 months.\n\nExclusion Criteria:\n\n1. Significant medical condition in either the mother or infant that, in the opinion of a medical investigator, may interfere with the study.\n2. Infant had confirmed sepsis or other serious infection in the neonatal period.\n3. Infants with known congenital diseases or who are immunocompromised or considered medically at risk (MAR).\n4. Infant participating in another interventional trial during the trial period.",true,"ALL","28 Days",{"count":21,"type":22},360,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to investigate whether administering a probiotic (Infloran®) to infants who received antibiotics in the first 28 days of life can restore or enhance their immune response to routine vaccines.\n\nAntibiotic use in the first weeks of life can lower the levels of beneficial gut bacteria, such as bifidobacteria, which play a key role in immune function. As a result, infants treated with antibiotics may produce fewer antibodies after routine vaccinations, leaving them less protected against infections.\n\nThe main questions this study aims to answer are:\n\n* Does treatment with the probiotic Infloran® improve the geometric mean concentrations (GMCs) of anticapsular antibodies against at least 11 serotypes included in the pneumococcal conjugate vaccine (PCV20) in serum samples collected at 6 months of age compared with placebo in infants treated with antibiotics in the neonatal period?\n* Does treatment with the probiotic Infloran® improve the GMCs for the pneumococcal conjugate vaccine (PCV20) at 12 months of age compared with placebo in infants treated with antibiotics in the neonatal period?\n* Does treatment with the probiotic Infloran® improve the GMCs of other routine childhood vaccines at 6 and 12 months of age compared with placebo in infants treated with antibiotics in the neonatal period?\n* Does treatment with the probiotic Infloran® increase the proportion of infants achieving seroprotective antibody levels for pneumococcal antigens compared to placebo in infants treated with antibiotics in the neonatal period?\n* What are the differences in antigen specific T cell responses, flow cytometry, blood transcriptomics, and gut microbiota composition in the probiotic (Infloran®) vs placebo groups in infants treated with antibiotics in the neonatal period?\n\nResearchers will compare infants who receive Infloran® (a probiotic containing Bifidobacterium bifidum and Lactobacillus acidphilus) with those who receive a placebo (which contains the same excipients as Infloran® but does not contain any bacterial strains).\n\nParticipants will:\n\n* Be randomly assigned to receive either a 14-day course of probiotic Infloran® or a placebo.\n* Provide blood samples (3-5 mL) at 6 weeks, 6.5 weeks (optional blood-draw for exploratory endpoint), 6 months and 12 months of age.\n* Provide stool samples at four timepoints: prior to starting the intervention (probiotic\u002Fplacebo), on day 7, on day 14 after completion of the study supplement, and prior to their first vaccination at 6 weeks of age.\n* Receive routine vaccinations at 6 weeks, 4 months and 6 months in line with the National Immunisation Program\n* Complete surveys to collect information regarding probiotic\u002Fplacebo administration and vaccination related side effects\n\nThis study aims to recruit 360 infants to assess whether this probiotic treatment following antibiotic exposure improves the immunogenicity of vaccinations. The information from this study will improve our understanding of how probiotic intervention can support optimal immune responses to vaccination in early life. The findings could potentially influence public health strategies, offering a new way to support optimal vaccine responses in antibiotic-treated infants.",[28,29,30,31,32],"Infant, Newborn","Immunity","Immunisation","Antibiotic Treatment","Microbiome Dysbiosis",[34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],"infant","newborn","neonate","antibiotic","microbiome","microbiota","gut","probiotics","bifidobacteria","bifidobacterium","infloran","immunisation","immunity","immune system","vaccine","vaccination","immunization","randomised controlled trial","randomized controlled trial","RECRUITING","2026-05-24",{"date":56,"type":57},"2026-05-28","ACTUAL",{"date":59,"type":57},"2026-05-25",{"date":61,"type":22},"2029-10",{"name":63,"class":64},"South Australian Health and Medical Research Institute","OTHER",2,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":18,"minAge":73,"maxAge":4,"enrollmentInfo":74,"targetDuration":19,"studyType":76,"phases":4,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":93},"100602873","pulmonary-microbiota-changes-and-clinical-outcomes-in-neurosurgical-icu-patients-with-artificial-airways-100602873","NCT07129174","Pulmonary Microbiota Changes and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways","Association Between Changes in Pulmonary Microbiota and Clinical Outcomes in Neurosurgical ICU Patients With Artificial Airways: A Prospective Observational Cohort Study","Inclusion Criteria:\n\n* Patients must meet all of the following conditions to be eligible for inclusion:\n\n  1. First admission to the Intensive Care Unit (ICU).\n  2. Assessed by an ICU specialist as expected to require artificial airway support (e.g., mechanical ventilation) for more than 24 hours.\n  3. Neurosurgical patients. Postoperative neurosurgical patients are defined in this study as those who have undergone surgery for: brain tumors, Subarachnoid hemorrhage, Traumatic brain injury\n\nExclusion Criteria:\n\n* Patients meeting any of the following criteria will be excluded:\n\n  1. Age under 18 years\n  2. Pregnancy\n  3. Pre-existing spinal cord injury\n  4. History of chronic pulmonary diseases, including: Chronic bronchitis, Chronic obstructive pulmonary disease (COPD), Bronchial asthma, Bronchiectasis, Interstitial lung disease, Pleural effusion\n  5. Pre-existing immunosuppressive conditions, including: Systemic immunomodulatory therapy, Chemotherapy, HIV infection, Other congenital or acquired immunodeficiency disorders\n  6. Receipt of systemic antimicrobial therapy within the past 3 months\n  7. Diagnosis of primary lung cancer or lung metastases from other tumors\n  8. History of partial lung resection for any reason","18 Years",{"count":75,"type":22},220,"OBSERVATIONAL","After neurosurgery, many patients need to stay in the intensive care unit (ICU) and use a breathing machine (mechanical ventilation) because of issues like decreased consciousness, weak breathing, or poor airway protection. During this period, the natural balance of bacteria in the lungs-known as the lung microbiota-can be disturbed by surgery, antibiotics, and airway procedures. This may reduce healthy bacteria and allow harmful bacteria to grow, increasing the risk of lung infections such as ventilator-associated pneumonia (VAP).\n\nThis study will follow 220 postoperative neurosurgical ICU patients at three centers: Beijing Tiantan Hospital, Beijing Shijitan Hospital, and Beijing Anzhen Hospital from August 2025 to August 2026. These patients will include those undergoing surgery for brain tumors, brain hemorrhage, or traumatic brain injury. Airway secretion samples (tracheal aspirates) will be collected shortly after surgery and at several subsequent time points to assess how lung bacteria change over time while patients are using a breathing machine.\n\nUsing advanced laboratory methods, the investigators will measure both the amount and types of bacteria in the lungs. The aim is to determine how these changes are related to patient outcomes, such as the occurrence of lung infections.\n\nThe results of this study may contribute to earlier detection of lung infections and the development of personalized treatment plans to improve recovery in ICU patients after neurosurgery.",[79,80,32],"Ventilator-Associated Pneumonia (VAP)","Intensive Care Unit (ICU) Patients",[79,82,83],"Intensive care unit (ICU)","Pulmonary Microbiota","2026-05-19",{"date":86,"type":57},"2026-05-22",{"date":88,"type":57},"2025-08-30",{"date":90,"type":22},"2026-08-30",{"name":92,"class":64},"Jian-Xin Zhou",3,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":17,"sex":18,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":125},"100600128","colon-delivered-riboflavin-and-gut-microbiota-composition-100600128","NCT07093463","Colon-delivered Riboflavin and Gut Microbiota Composition","The Benefit of Colon-delivered Riboflavin (Riboflavin-cd) vs. Conventional Riboflavin on Gut Microbiota Composition and Metabolic Output in Healthy Aging Subjects - a Pilot Proof of Concept Study","CONCOL","Inclusion Criteria:\n\n1. Individuals providing written informed consent for participation in the study and data processing\n2. Female and males between 50 and 70 years of age\n3. For females only: Menopausal as marked by at least 1 year since the last menstrual bleeding\n4. Individuals with a BMI between 18.5 - 29.9 Kg\u002Fm2\n5. Individuals with stable body weight (≤5% change) over the past 3 months prior to V1\n6. Individuals with self-reported moderate bowel complaints in at least last 3 months prior to V1\n7. Individuals with GSRS score suggestive of moderate bowel complaints, as assessed at V1, for the average condition over the 4 last weeks (all GSRS items have to be answered at V1): • indigestion score 3-5 or constipation score 3-5 or diarrhoea score 3-5\n8. Individuals with a general good health, as determined by questioning, clinical examination and vital signs (blood pressure, pulse rate) by the investigator at V1\n9. Individuals willing to avoid consuming gut microbiome modulating dietary supplements, prebiotic, probiotic, synbiotic or fibre-rich supplements during the entire study duration\n10. Individuals willing to maintain current level of physical activity throughout the entire study duration\n11. If individuals are taking chronic medications (e.g., antihypertensive medications), they must be willing and expected to maintain the same dosage throughout the study\n\nExclusion Criteria:\n\n1. Individuals who are hypersensitive\u002Fintolerant to any of the components of the Investigational product or the standardised diet addition (inulin)\n2. Individuals who have taken systemic antibiotics within the previous 3 months prior to Baseline (V2) or are expected to be taking any during the study\n3. Individuals who consumed microbiome modulating dietary supplements, prebiotic, probiotic, or fibre-rich supplements within 4 weeks prior to the baseline (V2)\n4. Individuals who are currently regularly using systemic steroids, proton pump inhibitors, H2 blocker, antacids (however, sporadic use during the study if needed is allowed, but not within 8 hours before each visit), metformin if started less than 6 months prior to V1, or immunosuppressant medication.\n5. Individuals who have a history of drug abuse in the previous 5 years and\u002For alcohol abuse at the time of enrolment (\\>11 units\u002Fweek for women; \\>17 units\u002Fweek for men; unit: approx. 125 mL of wine or similar \u002F approx. 30 mL of spirits\n\n   \u002F approx. 280 mL beer or similar); Is currently in treatment for alcohol\u002Fsubstance abuse; Has been diagnosed with alcohol\u002Fsubstance abuse disorder)\n6. Individuals who are a smoker or vaper\n7. Individuals who are vegetarian or vegan\n8. Individuals who have made any major dietary changes in the past 3 months prior to Baseline (V2)\n9. Individuals who have planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.\n10. Individuals who have a currently present active eating disorder\n11. Individuals with self-reported food allergy \u002F intolerance (e.g., lactose, gluten, fructose), as determined by the study investigator\n12. Clinical significance for any of screening laboratory test results from the blood draw at V1, as per investigator's judgement\n13. Individuals with a self-reported fibre-rich regular diet, as per investigator's judgement\n14. Individuals who have a (self-reported) gastrointestinal disorder\u002Fdisease (e.g., chronic\u002Frecurrent diarrhoea, inflammatory bowel disorder, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, bile acid malabsorption) or previous gastrointestinal surgery (such as bariatric surgery, colon specific surgical interventions etc.), which in the opinion of the investigator would impact the study outcomes\n15. Individuals with GSRS assessed at V1 for the average condition over the 4 last weeks prior to V1 for any score (abdominal pain, reflux score, indigestion, constipation, diarrhoea) \\>5 (all GSRS items have to be answered at V1)\n16. Individuals who have severe or uncontrolled conditions such as type 2 diabetes (FBG ≥ 150 mg\u002Fdl from blood draw at V1), psychiatric disorder, respiratory or cardiac illness or any other condition which in the opinion of the investigator would impact the study outcomes\n17. Individuals who have a history of any gastrointestinal cancer\n18. Individuals who are severely immunocompromised\n19. Individuals with alarm features in the past 3 months prior to V1 such as unintentional weight loss (≤5% change), fever, anorectal problems, blood in stool, vomiting\n20. Individuals who, in the opinion of the investigator are considered to be poor attendees or unlikely for any reason to be able to comply with the study requirements\n21. If Individuals have been in a recent experimental study, this must have been completed not less than 30 days prior to this study","50 Years","70 Years",{"count":105,"type":22},90,[107],"NA","Recent studies suggest B-vitamins such as riboflavin to possess prebiotic-like effects. However, there is still a lack of understanding of the exact host health benefits vs. conventional systemically available vitamin forms. The present study explores the benefit of colon-delivered vitamin B2 vs. conventional vitamin B2 in comparison to placebo in an aging population on gut microbiota and metabolic activity as well as gut health.",[32,110],"Gut Health",[112,38,113,114],"elderly","colon delivered b-vitamins","riboflavin","2026-03-17",{"date":117,"type":57},"2026-03-19",{"date":119,"type":57},"2025-07-18",{"date":121,"type":22},"2026-09",{"name":123,"class":124},"dsm-firmenich Switzerland AG","INDUSTRY",1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":17,"sex":134,"minAge":73,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":145,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":158},"100513529","synbiotics-in-patients-at-risk-for-preterm-birth-100513529","NCT05966649","Synbiotics in Patients at RIsk fOr Preterm Birth","Synbiotics in Patients at RIsk fOr Preterm Birth: a Multi-center Double-blind Randomized Placebo-controlled trIal","PRIORI","Inclusion Criteria:\n\n1. Signed written informed consent must be obtained before any study assessment is performed;\n2. 18 years of age or older;\n3. Singleton pregnancy;\n4. Pregnancy consultation between 8 and 10 weeks gestation.\n5. At least one of the following risk factors for spontaneous preterm birth:\n\n   * Prior spontaneous preterm birth, defined as delivery between 24 and 36 weeks following PPROM, preterm labor or cervical insufficiency\n   * PPROM ≤36 weeks in previous pregnancy\n   * Prior spontaneous second-trimester pregnancy loss, defined as PPROM, preterm labor or cervical insufficiency with birth between 14 and 24 weeks.\n\nExclusion Criteria:\n\n1. Patients who are already using pro-, pre- or synbiotics and not willing to stop\n2. Multiple pregnancy\n3. Need for primary (type 1) cerclage\n4. Inflammatory bowel disease\n5. Known congenital uterine anomaly\n6. History of LLETZ conization","FEMALE",{"count":136,"type":22},402,[107],"Prematurity remains the main cause of death and serious health problems in new-borns. Besides the need for hospitalization and medical interventions in the first weeks or months of the new-borns' life, prematurity can cause long-lasting health problems (e.g. multiple hospital admissions, developmental delay, learning difficulties, motor delay, hearing or eye problems, ...). Moreover, prematurity places an enormous economic burden on the society. Aside from the medical problems and the financial cost, the emotional stress and psychological impact on the parents, siblings and other family members should not be underestimated.\n\nPrevious preterm delivery (before 37 weeks of pregnancy) increases the risk for recurrent preterm delivery in a subsequent pregnancy. Therefore, these women should be considered as 'high risk' for preterm birth.\n\nInfections ascending from the vagina may be an important cause of preterm delivery in certain cases. Some women have an abnormal vaginal microbiome and are therefore at risk for infections and preterm birth. On the other hand, the vaginal flora is more stable and resistant to infections in healthy pregnant women who deliver at term (after 37 weeks of gestation).\n\nSynbiotics are a mixture containing probiotics and prebiotics. Probiotics are living bacteria with potential beneficial effects that can be used safely in pregnancy, while prebiotics are consumed by the bacteria. It is known that probiotics, when used for a long period of time, can maintain a healthy and stable vaginal flora that may protect against infections. In this study, pregnant patients with a history of preterm birth will be included in the first trimester of pregnancy to start with synbiotics or placebo. The investigators will examine the effect of synbiotics on the vaginal flora and on the pregnancy duration. The hypothesis is that synbiotics, when started early in the pregnancy, can change the disturbed vaginal flora into a stable micro-environment.",[140,141,142,32,143,144],"Preterm Spontaneous Labor With Preterm Delivery","Preterm Birth","Microbial Colonization","Vaginal Microbiome","Synbiotics",[146,147,148,144],"Preterm birth","Vaginal microbiome","Probiotics","2026-02-23",{"date":151,"type":57},"2026-02-27",{"date":153,"type":57},"2023-03-16",{"date":155,"type":22},"2029-06",{"name":157,"class":64},"Ziekenhuis Oost-Limburg",9,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":4},"100622236","multi-omics-integrative-analysis-of-serum-and-sputum-to-uncover-key-determinants-of-prognosis-in-patients-with-ards-100622236","NCT07380997","Multi-Omics Integrative Analysis of Serum and Sputum to Uncover Key Determinants of Prognosis in Patients With ARDS","Inclusion Criteria:\n\n* Written and dated informed consent provided.\n* Age ≥18 years.\n* ARDS diagnosed according to the 2012 Berlin definition.\n* Clinically stable\n* eligible for enrollment after 12-24 hours of stability.\n* Baseline oxygenation index (PaO2\u002FFiO2 ≤300 mmHg)\n* No history of major chronic lung disease and no history of immunosuppression.\n* Able to comply with study procedures, including collection of blood\u002Fplasma and sputum samples and clinical data.\n\nExclusion Criteria:\n\n* Severe autoimmune disease or active systemic inflammatory disease.\n* Severe hepatic dysfunction or renal failure requiring dialysis.\n* Invasive mechanical ventilation for \\>36 hours prior to enrollment, or death prior to enrollment.\n* Expected death within 24 hours of admission or inability to complete study-related assessments due to imminent death.\n* Presence of a cardiac pacemaker or other implanted electronic device that may affect respiratory function assessment.\n* Pregnant or breastfeeding women.\n* Severe allergy to materials required for sample collection or other relevant contraindications.\n* Severe psychiatric illness or inability to cooperate with study procedures.\n* Prior participation in other interventional clinical trials that could affect interpretation of study results.\n* Refusal of consent or withdrawal of informed consent.",{"count":166,"type":22},411,"This study is a prospective observational investigation designed to systematically characterize key microbial signatures, metabolite profiles, and gene-expression features in serum and sputum from patients with acute respiratory distress syndrome (ARDS), and to evaluate their associations with response to invasive mechanical ventilation and clinical outcomes. A total of 411 adult ARDS patients meeting the Berlin definition and receiving invasive mechanical ventilation will be enrolled; individuals with significant pre-existing pulmonary disease or a history of immunosuppression will be excluded. Blood and sputum specimens will undergo high-throughput sequencing and metabolomics, including 16S rRNA-based microbiome profiling, whole-transcriptome RNA sequencing, and targeted\u002Funtargeted metabolite quantification by LC-MS\u002FMS. Ventilator-related parameters (e.g., tidal volume, positive end-expiratory pressure \\[PEEP\\], and respiratory system compliance) and clinical endpoints (e.g., 28-day mortality) will be integrated to establish a comprehensive multi-omics analytical framework.\n\nData preprocessing will include batch-effect correction, normalization, and multiple-testing adjustment with false discovery rate control (FDR \\\u003C 0.05). Differential microbes, metabolites, and transcripts will be functionally interpreted using KEGG pathway and Gene Ontology (GO) enrichment analyses. Spearman correlation analyses will be performed to examine associations between omics features and ventilator parameters. Key features will be selected using LASSO regression, followed by development of random forest and support vector machine (SVM) models to predict mechanical ventilation response and the risk of ventilator-induced lung injury (VILI). Model performance will be assessed using ROC curves, area under the curve (AUC), calibration plots, and decision curve analysis.\n\nBy integrating serum and sputum multi-omics data, this study aims to identify molecular biomarkers that influence the effectiveness of mechanical ventilation and prognosis in ARDS, thereby providing evidence to support precision ventilatory strategies and individualized clinical management to improve patient outcomes. The findings are expected to deepen mechanistic understanding of ARDS pathobiology and lay a foundation for future development of multi-omics-guided diagnostic and therapeutic approaches.",[169,32,170,171],"Acute Respiratory Distress Syndrome (ARDS)","Multiomics Analysis","Metabolomics","NOT_YET_RECRUITING","2026-01-24",{"date":175,"type":57},"2026-02-02",{"date":177,"type":22},"2026-03-01",{"date":179,"type":22},"2029-12-31",{"name":181,"class":64},"Ruijin Hospital",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":18,"minAge":73,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":23,"phases":191,"briefSummary":192,"conditions":193,"keywords":198,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":4},"100615649","accelerating-recovery-after-icu-admission-post-discharge-supplementation-with-pasteurized-akkermansia-muciniphila-100615649","NCT07295353","Accelerating Recovery After ICU Admission: Post-discharge Supplementation With Pasteurized Akkermansia Muciniphila.","PAM-ICU","Inclusion Criteria:\n\n* Age ≥18 years\n* Treated in the ICU for at least 2 days and discharged to a regular clinical ward\n* Diagnosed with sepsis during ICU admission\n* Received selective digestive decontamination (SDD) or cephalosporin\n* Capable of giving written informed consent\n\nExclusion Criteria:\n\n* Recent major gastrointestinal surgery\n* Diagnosed with ulcerative colitis or Crohn's disease\n* Presence of a hematological malignancy and\u002For current use of immunomodulatory therapy (e.g., CAR-T cell therapy or immune checkpoint inhibitors) Use of systemic immunomodulatory drugs or corticosteroids (defined as ≥10 mg prednisone equivalent daily at ICU discharge), at the time of inclusion.\n* History of solid organ or stem cell transplantation\n* Pregnancy or lactation\n* Donation of blood or plasma within 30 days prior to inclusion or planned donation during the intervention period\n* Any other condition that, in the opinion of the investigator, could pose a risk to the subject or interfere with study result",{"count":190,"type":22},50,[107],"The goal of this clinical trial is to learn if daily oral supplementation with pasteurized Akkermansia muciniphila (PAM), an EFSA-approved food supplement, can support recovery in adults who have recently been treated in the ICU for sepsis.\n\nThe main questions it aims to answer are:\n\n* Is PAM safe to take for 56 days after ICU discharge?\n* Does PAM increase the abundance of beneficial butyrate-producing bacteria in the gut?\n\nResearchers will compare PAM to a placebo (a capsule that looks the same but has no active ingredient) to see if PAM improves gut microbiota and immune recovery.\n\nParticipants will:\n\n* Take PAM or placebo capsules once daily for 56 days\n* Provide stool and blood samples at baseline, day 28, and day 56\n* Receive a follow-up phone call about their health 1 year after starting the study",[194,195,196,32,197],"Sepsis","Post Intensive Care Unit Syndrome","Critical Illness","Intensive Care Unit Survivors",[199,200,201,202,203,204,205,206],"Pasteurized Akkermansia muciniphila","Akkermansia muciniphila","Postbioticum","Microbiome","PAM","Gut Barrier Function","Post-Sepsis Recovery","Randomized Controlled Trial","2025-12-08",{"date":209,"type":57},"2025-12-19",{"date":211,"type":22},"2026-01",{"date":213,"type":22},"2028-01",{"name":215,"class":64},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":18,"minAge":224,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":76,"phases":4,"briefSummary":228,"conditions":229,"keywords":232,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":125},"100609011","dynamics-of-dysbiosis-in-the-skin-and-gut-microbiome-of-burn-patients-100609011","NCT07209007","Dynamics of Dysbiosis in the Skin and Gut Microbiome of Burn Patients","An Exploratory Study on the Dynamics of Microbiome Dysbiosis (Microbial Imbalance) in the Skin and Gut Microbiome of Burn Patients","BURN-MICRO","Inclusion Criteria\n\n* Adults aged 19 to 65 years\n* Patients with partial- or full-thickness burns whose wounds have completely healed following debridement, grafting, or conservative treatment\n* Ability to understand study objectives and provide written informed consent\n\nExclusion Criteria\n\n* Use of systemic or topical antibiotics, probiotics, steroids, or immunosuppressants within 2 weeks prior to sample collection\n* Pregnancy or breastfeeding\n* Chronic skin diseases (e.g., psoriasis, eczema) or systemic illnesses affecting the skin microbiome\n* Active infections at the sampling site\n* Any medical condition judged by the investigator to make participation inappropriate","19 Years","65 Years",{"count":227,"type":22},600,"This prospective observational cohort study aims to investigate the longitudinal changes in the skin and gut microbiome of burn patients after injury and compare them with healthy controls. Burn injuries are known to induce systemic physiological and immune responses that may lead to widespread microbial dysbiosis (microbial imbalance) beyond the injured site. However, the dynamics of microbial community changes in both burned and non-burned skin, as well as the gut, remain poorly understood.\n\nIn this study, a total of 660 participants will be enrolled, including 600 burn patients and 60 healthy controls. For burn patients, skin swabs from burned scars and matched non-burned skin, stool samples, and physiological skin measurements will be collected at multiple time points (baseline, 3 months, 6 months, 12 months, and 24 months). Healthy controls will provide skin and stool samples at baseline only.\n\nMicrobial profiling will be performed using 16S ribosomal RNA (rRNA) gene sequencing, and functional prediction will be analyzed using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2). Physiological skin-barrier measurements, including transepidermal water loss (TEWL), hydration, pH, erythema, and elasticity, will be assessed using standardized instruments. Blood biomarkers, including C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR), will also be measured.\n\nThe findings of this study will improve our understanding of burn-related microbial dysbiosis, provide insights into microbiome-driven skin-barrier recovery, and inform potential therapeutic strategies for long-term burn care.",[230,231,202,32],"Burn Injuries","Skin Disease",[233,234,235,236,237],"Burn Injury","Skin Microbiome","Gut Microbiome","Dysbiosis","16S rRNA Sequencing","2025-09-29",{"date":240,"type":57},"2025-10-06",{"date":242,"type":57},"2025-09-15",{"date":244,"type":22},"2030-12-31",{"name":246,"class":64},"Cho Yoon soo"]