[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microbial-colonization\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microbial-colonization":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,38,0,25,[9,42,68,95,122,144,167,199,221,254,275,303,331,357,378,402,434,465,492,517,543,573,602,626,650],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100527578","changes-in-microbial-status-from-dentate-edentulous-and-after-dental-implant-placement-100527578",false,"NCT06149585","Changes in Microbial Status From Dentate, Edentulous and After Dental Implant Placement","Inclusion Criteria:\n\n1. At least 21 years of age\n2. Diagnosis of Stage III or IV periodontitis based on full mouth probing and full mouth x-rays\n3. Planned for full mouth extraction and replacement by dental implants.\n4. Rehabilitation with Implant supported restorations either maxilla and\u002F or mandible.\n5. At least 2 implants available for examination.\n6. No bone augmentation required.\n\nExclusion Criteria:\n\n1. Conditions requiring chronic routine prophylactic use of antibiotics.\n2. Conditions requiring prolonged use of steroids.\n3. History of leukocyte dysfunction and deficiencies\n4. Bleeding disorders\n5. History of neoplastic disease requiring use of radiation or chemotherapy\n6. Metabolic bone disorders\n7. Uncontrolled endocrine disorder\n8. Use of any investigational drug or device within the 30 day period prior to implant surgery.\n\n10\\. Alcoholism or drug abuse 11. Patient infected with HIV 12. Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability.\n\nLocal Exclusion Criteria\n\n1. Local inflammation\n2. Mucosal disease such as erosive lichen planus\n3. History of local irradiation therapy\n4. Osseous lesion.\n5. Active infection with suppuration or fistula track.\n6. Persistent intraoral infection different than periodontitis",true,"ALL","21 Years",{"count":20,"type":21},12,"ESTIMATED","OBSERVATIONAL","The objectives of this study are to analyze the oral microbiome modulations occurring during the transition from partial (with some residual teeth) to full edentulous (without remaining teeth) status and implant placement in subjects affected by severe periodontitis; to evaluate if microbiome changes in relation to the used of different implant material\u002Fsurface; and to assess the variance of the changes to determine the sample size for future longitudinal prospective studies.",[25,26,27,28],"Edentulous Mouth","Periodontal Diseases","Periodontitis, Adult","Microbial Colonization","RECRUITING","2026-06-29",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":35,"type":33},"2023-08-16",{"date":37,"type":21},"2028-05-01",{"name":39,"class":40},"Case Western Reserve University","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":16,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100536391","phase-1-restoration-of-the-gut-microbiome-after-cesarean-section-100536391","NCT06264219","Restoration of the Gut Microbiome After Cesarean Section","\"Restoration of the Gut Microbiome After Cesarean Section (RestoreGut)\" - A Double-blinded Randomized Placebo-controlled Trial","RestoreGut","Inclusion Criteria:\n\n* Gestational age \\\u003C week 38+0 days\n* Proficient in spoken\u002Fwritten Danish\n* Single pregnancy (no twins or triplets)\n* Pre-pregnancy BMI between 18.5 and 35 kg\u002Fm2\n* No chronic intestinal, endocrine, cardiac, or kidney disorders\n* No known gestational complications (gestational diabetes, preeclampsia, gestational hypothyroidism)\n* No regular use of prescription medication or any drugs that, in the research team's opinion, may interfere with the study's results.\n* Willingness to abstain from giving the child products with probiotics (fermented dairy like yogurt or A38 are allowed).\n\nExclusion Criteria:\n\nMaternal:\n\n* Use of antibiotics within one month of stool donation\n* Acute gastroenteritis within one month of stool donation\n* Use of antibiotics within one month of birth\n* Time since last travel abroad relative to data of fecal donation according to the requirements for blood donations (\"Regler for tappepauser\" - blooddonor.dk)\n* Positive test results for pathogens during donor material screening.\n* Antibiotic treatment at birth (vaginal births only)\n* Spontaneous onset of labor or emergency cesarean section before scheduled cesarean section.\n\nInfant:\n\n* Instances of major birth defects or intrauterine growth retardation (IUGR)\n* Infants requiring pediatric support at the time of transplant administration","FEMALE","18 Years",{"count":53,"type":21},80,"INTERVENTIONAL",[56],"PHASE1","This study aims to develop a therapy for restoring the gut microbiome in infants born via CS. The Study will conduct a randomized, placebo-controlled feasibility trial to assess the ability of microbiome restoration by FMT and FVT in infants born by cesarean section.",[28],"2026-06-25",{"date":30,"type":33},{"date":62,"type":33},"2024-08-02",{"date":64,"type":21},"2027-08-30",{"name":66,"class":40},"Jakob Stokholm",2,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":16,"sex":17,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":54,"phases":79,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":41},"100537863","phase-1-comparing-single-versus-repeat-nmt-on-the-diversity-of-the-neonatal-nasal-microbiome-100537863","NCT06283355","Comparing Single Versus Repeat NMT on the Diversity of the Neonatal Nasal Microbiome","Comparing Single Versus Repeat Parent-to-Child Nasal Microbiome Transplant on Seeding, Engraftment, and Diversity of the Neonatal Nasal Microbiome","Inclusion Criteria:\n\nNeonate:\n\n1. Neonate has anticipated NICU length of stay \\> 7 days\n2. Neonate ≥25 weeks gestation\n3. At least one parent\u002Fadult provider not colonized with S. aureus (as determined by baseline screening)\n4. Neonate is not colonized with S. aureus on baseline screening\n\nParent\u002FAdult provider:\n\n1\\. Parent\u002FAdult provider is able to provide informed consent\n\nExclusion Criteria:\n\nNeonate:\n\n1. Neonate has had a prior clinical or surveillance culture grow S. aureus\n2. Neonate is a ward of the State\n3. Neonate with antenatal suspicion for immunodeficiency (e.g. sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)\n4. Neonate cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)\n\nParent\u002FAdult provider:\n\n1. Parent\u002Fadult provider had positive COVID-19 test in prior 21 days\n2. Parent\u002Fadult provider with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)\n3. Parent\u002Fadult provider has been in close contact with someone in the last 7 days who had a respiratory viral infection, like the cold or the flu?\n4. Parent\u002Fadult provider tests positive on baseline screening test for S. aureus nasal colonization.\n5. Parent\u002Fadult provider tests positive on baseline screening test for a respiratory pathogen.\n6. Parent\u002Fadult provider is not able to provide written informed consent\n7. Parent\u002Fadult provider is not able to be present at the bedside at the time of intervention.\n8. Parent\u002Fadult provider has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.\n9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire","0 Years","60 Years",{"count":78,"type":21},175,[56],"This study aims to determine whether a parent-to-child nasal microbiota transplant (NMT) can seed and engraft parental organisms into the neonatal microbiome and increase the neonatal microbiome diversity.",[82,28,83],"Staphylococcus Aureus","Neonatal Infection",[85],"microbiome","2026-06-04",{"date":88,"type":33},"2026-06-08",{"date":90,"type":33},"2024-09-03",{"date":92,"type":21},"2026-12-31",{"name":94,"class":40},"Johns Hopkins University",{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":54,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":41},"100590657","fmt-for-lung-and-associated-organ-rescue-efficacy-in-mdro-infected-ventilated-patients-100590657","NCT06970262","FMT for Lung and Associated-organ Rescue Efficacy in MDRO-infected Ventilated Patients","FMT for Lung and Associated-organ Rescue Efficacy in Multidrug-resistant Organism (MDRO)-Infected Ventilated Patients: a Single-center, Open-Label, Randomized Controlled Trial","FLARE-MV","Inclusion Criteria:\n\n1. Age 18-70 years, inclusive, irrespective of sex or ethnic background;\n2. Admission to the intensive care unit (ICU) within 24-48 hours;\n3. Anticipated ICU length of stay of ≥7 days, as determined by the attending intensivist prior to enrollment;\n4. Mechanically ventilated patients with MDRO infection;\n5. Provision of written informed consent by the participant or legally authorized representative.\n\nExclusion Criteria:\n\n1. Severe systemic infection during early resuscitation, accompanied by hemodynamic instability, profound tissue hypoperfusion, or life-threatening electrolyte and acid-base disturbances;\n2. Clinician-assessed high risk of mortality within 5 days, or presence of formal treatment-limiting directives (e.g., do-not-intubate or do-not-resuscitate orders);\n3. Active gastrointestinal bleeding or perforation consistent with severe intestinal barrier dysfunction;\n4. Inability to tolerate enteral nutrition providing ≥50% of estimated caloric requirements due to structural intestinal pathology-including fibrotic bowel stenosis or high-output enterocutaneous fistula;\n5. Planned abdominal surgery or history of abdominal surgery within 14 days prior to enrollment;\n6. Confirmed diagnosis of fulminant colitis or toxic megacolon;\n7. Neutropenia defined as absolute neutrophil count \\\u003C 1.5 × 10⁹\u002FL;\n8. Recent exposure to high-risk immunosuppressive or cytotoxic agents within the preceding 3 months, including but not limited to: rituximab (within 6 months), anthracyclines (e.g., doxorubicin), or systemic corticosteroids at ≥20 mg\u002Fday prednisone-equivalent dose for ≥4 consecutive weeks;\n9. Pregnancy or lactation;\n10. Participation in another interventional clinical trial within 3 months prior to enrollment or ongoing at the time of study entry.","70 Years",{"count":105,"type":21},60,[107],"NA","Multidrug-resistant organism (MDRO)-infection represents a substantial global health burden. In the intensive care unit (ICU), the concurrent administration of antibiotics, opioids, proton pump inhibitors (PPIs), vasoconstrictors, and parenteral nutrition-compounded by the intrinsic severity of critical illness-induces profound gut microbiota dysbiosis. Accumulating preclinical and clinical evidence indicates that such intestinal dysregulation may trigger distal immunomodulatory and microbial shifts in the lung via the gut-lung axis, thereby contributing to pulmonary microecological imbalance and impairing recovery trajectories. Although pulmonary microecology has garnered increasing scientific attention, the causal and temporal relationship between gut dysbiosis and the establishment or exacerbation of pulmonary microbial dysbiosis in MDRO-infecction remains inadequately characterized. As a result, it is currently unclear whether gut dysbiosis serves as a primary pathogenic driver, a disease-amplifying factor, or a secondary epiphenomenon in the context of MDRO-infecction-associated lung injury.\n\nFecal microbiota transplantation (FMT) is a targeted microbiome-modulating intervention that involves the transfer of functionally diverse, minimally processed microbial communities from comprehensively screened healthy donors to restore ecological stability and functional redundancy in the recipient gut. Robust clinical data demonstrate that FMT effectively decolonizes the gastrointestinal tract of MDROs and reduces the incidence of secondary infections in immunocompetent, non-critically ill populations. Over the past decade, FMT has demonstrated reproducible efficacy in recurrent Clostridioides difficile infection and emerging promise in select extra-intestinal inflammatory conditions-highlighting its capacity as a mechanism-informed strategy for systemic host-microbe recalibration. Given the established role of the gut as a reservoir for enteric pathogens implicated in sepsis, hospital-acquired bloodstream infections, and ventilator-associated pneumonia (VAP), we propose a prospective, single-center, open-Label, randomized controlled trial (RCT) enrolling mechanically ventilated adults with MDRO-infeccted ventilated patients. The primary objective is to evaluate whether adjunctive FMT-delivered via nasojejunal tube-decrease 28-day mortality.",[110,28,111],"Lung Infection","Food Intolerance Syndromes","NOT_YET_RECRUITING","2026-04-28",{"date":115,"type":33},"2026-05-05",{"date":117,"type":21},"2026-05-30",{"date":119,"type":21},"2027-12-31",{"name":121,"class":40},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology",{"id":123,"slug":124,"hasResults":12,"nctId":125,"briefTitle":126,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":54,"phases":130,"briefSummary":132,"conditions":133,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":41},"100470089","phase-4-skin-preparation-for-elective-foot-and-ankle-surgery-100470089","NCT05401292","Skin Preparation for Elective Foot and Ankle Surgery","Inclusion Criteria:\n\n* patients undergoing elective foot and ankle surgeries\n* age over 18\n\nExclusion Criteria:\n\n* trauma as the indication for surgery\n* open injuries\n* non-elective procedures\n* amputations\n* prior surgical site infection through the planned incision\n* pregnancy. All potential participants of child-bearing potential follow the standard pre-operative protocol to ensure they are not in pregnant status prior to SOC surgical procedure.",{"count":129,"type":21},100,[131],"PHASE4","Surgical site infections (SSIs) make about 31% of all nosocomial infections and they are the most common hospital-acquired infection. For foot and ankle elective interventions, SSI rate is reported between 0.4% and 3.6%. This study will investigate the effectiveness of skin cleaning with isopropyl alcohol and scrubbing with chlorhexidine soap before standard skin preparation in reducing microbial load and surgical site infections for elective foot and ankle surgeries. Current standard of care includes skin preparation with iodine or chlorhexidine solution prior to sterile draping and the start of surgery. Standard of care will be applied to all patients. The use of an additional \"pre-scrub\" with isopropyl alcohol and scrubbing with chlorhexidine soap will be applied to the experimental group. The control group will receive only the standard of care skin preparation with iodine or chlorhexidine solution prior to draping.",[28,134],"Foot and Ankle Disorders","2026-04-23",{"date":137,"type":33},"2026-04-27",{"date":139,"type":33},"2022-02-15",{"date":141,"type":21},"2026-12",{"name":143,"class":40},"University of Missouri-Columbia",{"id":145,"slug":146,"hasResults":12,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":151,"enrollmentInfo":152,"targetDuration":4,"studyType":54,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":4},"100632312","oral-lactobacillus-reuteri-for-skin-barrier-dysfunction-in-obesity-100632312","NCT07512050","Oral Lactobacillus Reuteri for Skin Barrier Dysfunction in Obesity","A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Oral Lactobacillus Reuteri in Treating Skin Barrier Function Impairment Caused by Obesity.","Inclusion Criteria:\n\n* 1\\. Meets 2020 WHO BMI classification:\n* a. Normal weight (18.5-24.9 kg\u002Fm²)\n* b. Overweight (25-29.9 kg\u002Fm²)\n* c. Obesity (≥30 kg\u002Fm²)\n* 2\\. Presence of skin barrier impairment (e.g., dryness, erythema, desquamation, or itching)\n* 3\\. Age 18-40 years\n* 4\\. Generally good health (no active systemic diseases)\n* 5\\. Able and willing to provide written informed consent\n* 6\\. No use of oral\u002Ftopical medications or probiotics within 6 months prior\n* 7\\. No active skin disease or traumatic skin lesions\n\nExclusion Criteria:\n\n* 1\\. Known allergy or hypersensitivity to probiotics, placebo, or investigational product\n* 2\\. Active skin disease (e.g., psoriasis, eczema, infection) requiring treatment\n* 3\\. Severe medical conditions:\n* a. Cardiopulmonary disease (NYHA class III\u002FIV)\n* b. Uncontrolled diabetes (HbA1c \\>9%)\n* c. Autoimmune disorders\n* 4\\. Pregnant or breastfeeding women\n* 5\\. Any condition that may interfere with protocol compliance (per investigator judgement), including:\n* a. Inability to understand study procedures\n* b. History of poor clinical trial adherence\n* 6\\. Concurrent participation in other interventional trials","40 Years",{"count":153,"type":21},140,[107],"This clinical trial aims to evaluate the safety and efficacy of oral Lactobacillus reuteri supplementation for treating obesity-induced skin barrier impairment in individuals aged 18-40 with a BMI ≥30. The study focuses on the following questions:\n\nCan oral Lactobacillus reuteri supplementation reduce skin barrier damage (measured by transepidermal water loss\u002FTEWL) in obese participants? Does modulation of gut microbiota with Lactobacillus reuteri impact skin barrier function and systemic inflammation?\n\nResearchers will compare outcomes across two groups:\n\nIntervention Group (Obese): Oral Lactobacillus reuteri capsules. Placebo Control Group (Obese): Oral inactive (heat-killed) Lactobacillus reuteri.\n\nParticipant Procedures:\n\nTake daily oral capsules (Lactobacillus reuteri or inactive strain) for 4 weeks.\n\nUndergo non-invasive skin testing (TEWL measurements) at baseline and study completion.\n\nProvide stool and samples for analyses. Complete weekly check-ins to report adverse effects (e.g., gastrointestinal discomfort, skin irritation).",[157,28],"Skin Barrier to Water Loss","2026-03-31",{"date":160,"type":33},"2026-04-06",{"date":162,"type":21},"2026-04-10",{"date":164,"type":21},"2026-07-30",{"name":166,"class":40},"Shenzhen People's Hospital",{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":16,"sex":50,"minAge":51,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":54,"phases":177,"briefSummary":178,"conditions":179,"keywords":185,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":198},"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",{"count":176,"type":21},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.",[180,181,28,182,183,184],"Preterm Spontaneous Labor With Preterm Delivery","Preterm Birth","Microbiome Dysbiosis","Vaginal Microbiome","Synbiotics",[186,187,188,184],"Preterm birth","Vaginal microbiome","Probiotics","2026-02-23",{"date":191,"type":33},"2026-02-27",{"date":193,"type":33},"2023-03-16",{"date":195,"type":21},"2029-06",{"name":197,"class":40},"Ziekenhuis Oost-Limburg",9,{"id":200,"slug":201,"hasResults":12,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":16,"sex":17,"minAge":207,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":54,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":219,"locationsCount":41},"100529700","donor-milk-to-repair-the-full-term-infant-microbiome-in-infants-born-via-cesarean-section-100529700","NCT06177184","DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Cesarean Section.","DOnor Milk to REpair the Full-term Infant MIcrobiome in Infants Born Via Caesarean Section","DO-RE-MI C-S","Inclusion Criteria:\n\n* Gestation greater than 37 weeks gestation (full-term)\n* Caesarean Section delivery\n* Intending to breastfeed\n* Consent for infant to receive DHM\n* Working understanding (proficient in reading and understanding) of English\n* Mother has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations.\n* In the investigator's opinion, the subject mother understands and can comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned.\n\nExclusion Criteria:\n\n* Diagnosed with clinically significant major congenital malformation that will interfere with breastfeeding or growth\n* No intention to breastfeed","37 Weeks",{"count":209,"type":21},90,[107],"The objective of this novel study is to establish proof of concept using a pilot randomized controlled trial to determine the effect of DHM compared to formula supplementation on the microbiome in full-term infants who are born via caesarean section and require supplementation. Secondarily, this study aims to compare the infant health outcomes of sleep and growth between groups to assess if these outcomes are mediated by infant feeding type or potential differences in microbial signatures. Finally, this study will compare maternal outcomes of depression, anger, breastfeeding self-efficacy and breastfeeding rates between groups.\n\nThe infant gut microbiome plays a critical role in the developing immune, neurologic, and endocrine systems. Yet, most infants experience early life disruptions (ELDs) to their microbiome that have potential long-term health and development impacts. A major source of disruption is caesarean section (c-section) delivery because the infant is born surgically and is not exposed to important commensal bacteria required to establish the infant microbiome. Currently in Canada, over 28% of infants are born via c-section.\n\nExclusive breastfeeding can improve gut microbiota composition in infants who are born via c-section. However, approximately 60% of infants born via c-section require formula supplementation in their first week of life. Evidence indicates that even one bottle of formula can further disrupt the gut microbiome.\n\nDonor human milk (DHM) is a superior alternative to formula when supplementation is required as its biotic properties minimize perturbations to the infant gut microbiome and may help to repair the microbiome in infants who experience ELDs. Yet, while DHM is well researched in preterm populations, evidence on the impact of DHM as a therapeutic intervention on the full-term infant gut microbiome is lacking.\n\nThe hypothesis of this study is: that replacing formula with DHM supplementation will minimize gut microbiome dysbiosis and foster homeostasis following supplementation. In addition, it is hypothesized that improved homeostasis will promote improved sleep and growth outcomes in participant infants. Finally, mothers whose infants receive DHM will have lower depression and anger scores and higher breastfeeding self-efficacy and exclusive breastfeeding rates compared to mothers whose infants receive formula.",[28],"2026-02-18",{"date":215,"type":33},"2026-02-20",{"date":217,"type":33},"2024-10-01",{"date":119,"type":21},{"name":220,"class":40},"University of Calgary",{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":231,"conditions":232,"keywords":241,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":41},"100625994","changes-in-bile-acids-and-microbiota-in-patients-with-hepatitis-d-treated-with-bulvertide-100625994","NCT07429864","Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide","Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection","Bio-Delta","Inclusion Criteria:\n\n* Patients with chronic HDV-related hepatitis or compensated liver cirrhosis (Child-Pugh class A)\n* Positive HDV RNA within the 24 weeks prior to enrollment\n* Ongoing antiviral therapy for HBV at the time of enrollment\n* First prescription of Bulevirtide 2 mg issued within 30 days prior to enrollment\n* Caucasian ethnicity\n* Age ≥18 years\n* Normocaloric omnivorous diet\n* No intake of antibiotics, probiotics, or prebiotics in the month prior to enrollment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Decompensated liver cirrhosis (Child-Pugh Score B or C)\n* Patients without HBV-HDV-related infection\u002Fhepatitis\u002Fcirrhosis\n* Age ≤18 years\n* Pregnant or breastfeeding women\n* Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III\u002FIV, COPD GOLD C-D)\n* Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition",{"count":230,"type":21},20,"HDV is an RNA virus that infects only in the presence of HBV, affecting about 13% of HBsAg carriers. In Italy, prevalence ranges from 3.2% to 9.3%. It increases the risk of cirrhosis, fulminant hepatitis, and HCC, particularly in high-risk groups (HIV, HCV, drug users, dialysis patients). Until 2020, pegIFN was the only therapy; since 2022, bulevirtide (BLV) has been available, blocking viral entry into hepatocytes and reducing HDV RNA and liver stiffness, with efficacy in 45-48% of patients, though the optimal treatment duration remains uncertain. The gut microbiota and bile acids also play a role in fibrosis and cirrhosis progression: dysbiosis, typical in cirrhotic patients, alters bile acid metabolism and increases intrahepatic toxicity.",[233,234,235,236,237,238,239,240,28],"HBV","HBV Coinfection","HCV","HIV Infections","Hepatocellular Carcinoma","Cirrhosis, Liver","Fibrosis, Liver","Bile Acid Malabsorption",[242,243,244],"gut microbiota","Bile Acids","dysbiosis","2026-02-17",{"date":247,"type":33},"2026-02-24",{"date":249,"type":33},"2025-09-24",{"date":251,"type":21},"2027-10",{"name":253,"class":40},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":4,"eligibilityCriteria":259,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":260,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":262,"conditions":263,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":41},"100471140","assessment-of-the-ocular-microbiome-in-health-and-disease-100471140","NCT05414994","Assessment of the Ocular Microbiome in Health and Disease","Inclusion Criteria:\n\nWe will include subjects who meet all of the following criteria:\n\n* 18 years of age or older\n* Provide informed consent\n* Cohort A - normal eyes with no ocular disease\n* Cohort B - primary open angle glaucoma\u002FOcular hypertension defined as mild glaucoma which is well controlled with no more than one drop of prostaglandin use daily for the past 6 months\n* Cohort C - non-infectious keratopathy not using any prescription medication (OTC artificial tears are acceptable)\n* Cohort D - Dry AMD (age related macular degeneration)\n* Cohort E - Wet AMD\n* Cohort F - diabetic retinopathy\n\nExclusion Criteria:\n\nWe will exclude subjects who meet all of the following criteria:\n\n* Prior ocular disease either of the anterior or posterior segment\n* Any medical comorbidities except well controlled DH and HTN\n* Unable to follow up with study procedures as described",{"count":261,"type":21},500,"The objective of this application is to illustrate the core constituents of the ocular surface microbiome, describe factors that promote colonization, and assess the ocular microbiome's role in the health of the anterior segment. We will conduct a prospective, observational cohort study, including a longitudinal analysis of the ocular microbiome in adults.",[28,264,265],"Eye Diseases","Ophthalmopathy","2026-01-19",{"date":268,"type":33},"2026-01-22",{"date":270,"type":33},"2023-09-07",{"date":272,"type":21},"2027-12-30",{"name":274,"class":40},"Vanderbilt University Medical Center",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":279,"acronym":280,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":54,"phases":284,"briefSummary":285,"conditions":286,"keywords":289,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":41},"100496372","micronutrient-and-additive-modifications-may-optimize-diet-to-health-100496372","NCT05743374","Micronutrient and Additive Modifications May Optimize Diet To Health","Mammoth","Inclusion Criteria:\n\n* Ulcerative colitis,\n* Moderately active\n* Stable medication\n\nExclusion Criteria:\n\n* Severe disease\n* Recent surgery\n* Proctitis\n* Pregancy\n* Treatment with antibiotics\n* Difficulties in understanding the information about the study\n* Multimorbidity that makes it impossible to participate",{"count":283,"type":21},70,[107],"This is a prospective clinical intervention trial where patients with moderately active ulcerative colitis are randomized to either normal healthy diet or a diet with elimination of emulsifying agents within the E 400-group with special respect to carragenan, CMC and polysorbates. At study start and end after one month their diet, clinical characteristics and microbiota will be analysed. The hypotheses are that their disease activity measured with calprotectin and their microbiota will improve after intervention.",[287,288,28],"Ulcerative Colitis","Diet Habit",[290,291,292,293],"Ulcerative colitis","Diet","Microbiota","Emulsifying agent","2026-01-09",{"date":296,"type":33},"2026-01-12",{"date":298,"type":33},"2024-04-02",{"date":300,"type":21},"2029-12-31",{"name":302,"class":40},"Region Skane",{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":54,"phases":313,"briefSummary":314,"conditions":315,"keywords":319,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":41},"100485636","effects-of-mouthrinse-on-the-microbiome-of-the-oral-cavity-and-gi-tract-100485636","NCT05603650","Effects of Mouthrinse on the Microbiome of the Oral Cavity and GI Tract","Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract","Microbiome","Inclusion Criteria:\n\n* Eligible men and non-pregnant and non-lactating women of all races age 18-25.\n* Volunteers must consent to participate in all scheduled exam visits and procedures.\n* Volunteers must be available for follow up on the telephone.\n* Healthy gums or gums that bleed when you brush them.\n\nExclusion Criteria:\n\n* Volunteers unable or unwilling to sign the informed consent form.\n* Less than 20 teeth (excluding third molars).\n* Individuals who have taken antibiotics in the previous 3 months.\n* Presence of any condition, abnormality, or situation at Baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data.",{"count":312,"type":21},200,[107],"The purpose of this research study is to identify the effects of 2 over-the-counter mouthwashes on bacteria and 3 viruses in the participant's mouth and gut. The participant will be randomly allocated to rinse their mouth twice daily either with Listerine mouthwash, Lumineux Oral Essentials mouthwash, or water. The overall duration of the study will be approximately 180 days and will include approximately 5 visits and 15-30 minutes for each visit with a total of approximately 2.5 hours of your time. Additionally, fecal matter will also be collected in some subjects using a commercial collection kit.",[316,317,28,318],"Oral Bacterial Infection","Oral Infection","Viral Infection",[320,321],"Oral Microbiome","Fecal Microbiome","2025-12-16",{"date":324,"type":33},"2025-12-17",{"date":326,"type":33},"2021-09-01",{"date":328,"type":21},"2027-12",{"name":330,"class":40},"University of California, Irvine",{"id":332,"slug":333,"hasResults":12,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":337,"eligibilityCriteria":338,"healthyVolunteers":16,"sex":17,"minAge":75,"maxAge":76,"enrollmentInfo":339,"targetDuration":4,"studyType":54,"phases":340,"briefSummary":341,"conditions":342,"keywords":347,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":354,"leadSponsor":356,"locationsCount":41},"100578030","phase-1-administering-nmt-to-reestablish-infant-nasal-microbiome-diversity-following-intranasal-mupirocin-treatment-100578030","NCT06805994","Administering NMT to Reestablish Infant Nasal Microbiome Diversity Following Intranasal Mupirocin Treatment","Parent-to-Child Nasal Microbiota Transplant to Reestablish Nasal Microbiome Diversity After Intranasal Mupirocin Treatment of Children With Staphylococcus Aureus Nasal Colonization","NMT Protocol 3","Child:\n\nInclusion criteria\n\n1. Child has had a prior nasal surveillance culture grow S. aurues\n2. Child is \\\u003C18 years of age\n3. Child completed treatment with intranasal mupirocin for S. aureus nasal colonization as part of routine clinical care two or more days before the planned transplant\n4. Child has anticipated hospital length of stay \\>3 days after completing intranasal mupirocin treatment\n5. Infant \\>25 weeks gestation unless \\>2 months chronological age\n\nExclusion criteria\n\n1. Child is a ward of the State\n2. Child with a diagnosis of immunodeficiency or antenatal suspicion for immunodeficiency (e.g., sibling with known immunodeficiency, genetic syndrome with known associated immunodeficiency)\n3. Child cannot have nasal swabs collected (due to anatomic or other clinical intervention, including nasal packing)\n\nDonor:\n\nInclusion criteria\n\n1. Donor is able to provide informed consent\n2. Donor has a relationship with the child outside of the hospital setting (i.e., not an ICU caregiver)\n\nExclusion criteria\n\n1. Donor had positive COVID-19 test in prior 21 days\n2. Donor with signs or symptoms of respiratory illness (e.g. runny nose, congestion, fever, cough)\n3. Donor has been in close contact with someone in the last 7 days who had a respiratory viral infection (e.g., cold, flu)\n4. Donor tests positive on baseline screening test for S. aureus nasal colonization.\n5. Donor tests positive on baseline screening test for a respiratory pathogen.\n6. Donor is not able to provide written informed consent\n7. Donor is not able to be present at the bedside at the time of intervention.\n8. Donor has history of chronic sinusitis, cystic fibrosis, or an infection with a multi-drug resistant organism.\n9. Inability or unwillingness to complete the Donor questionnaire or a positive response to any question on the Donor questionnaire.\n10. Donor has smoked within the last month",{"count":78,"type":21},[56],"This protocol aims to evaluate how NMT affects pediatric nasal microbiome diversity following intranasal mupirocin treatment",[343,28,344,345,346],"Staphylococcal Aureus Infection","Pediatric Infection","S. Aureus Colonization","Microbial Transplant",[85,348,349],"s. aureus","staph","2025-08-27",{"date":352,"type":33},"2025-09-04",{"date":350,"type":33},{"date":355,"type":21},"2028-01-01",{"name":94,"class":40},{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":363,"enrollmentInfo":364,"targetDuration":366,"studyType":22,"phases":4,"briefSummary":367,"conditions":368,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":376,"locationsCount":41},"100460416","understanding-the-burn-wound-microbiome-comparing-traditional-wound-cultures-to-next-generation-sequencing-technology-100460416","NCT05275335","Understanding the Burn Wound Microbiome: Comparing Traditional Wound Cultures to Next Generation Sequencing Technology","Inclusion Criteria:\n\n* All adult patients (18 years of age and greater) admitted to or consulted by the Acute Burn Surgery service with a diagnosis of a partial thickness or full thickness burn wound determined by the Acute Burn Surgery service to be appropriate for operative intervention. We will include patients 18 years of age and older of any gender, race, prior therapy, or pre-existing medical condition. We will also include subjects in special classes, including pregnant women and cognitively impaired persons.\n\nExclusion Criteria:\n\n* Children (less than 18 years of age) will be excluded. Patients who do not undergo operative therapy or patients whose operative therapy does not involve tangential excision of burn wounds will also not be eligible for inclusion by virtue of not being able to provide appropriate biospecimens. Patients whose burn wounds are isolated to the genitalia and perineum will be excluded from the study. For patients who have multiple burn wounds including those to the genitalia and perineum, it should be noted that excised tissues from the genitalia and perineum are not eligible for inclusion to the Burn Wound Data\u002FBio-Repository. Finally, patients whose operative intervention results in less than a total of 4 grams of discarded tissue will be excluded due to insufficient specimen for proper tissue analysis. Any tissue allocated for pathology or that has already been physically discarded into a trash receptacle will not be eligible for inclusion in the Burn Wound Data\u002FBio-Repository. We will also exclude prisoners from this study.","100 Years",{"count":365,"type":21},400,"1 Day","The purpose of this investigation is to better understand the wound microbiome in burn wounds and the role it plays in outcomes and complications related to treatment.",[28,369],"Burns","2025-08-14",{"date":372,"type":33},"2025-08-15",{"date":374,"type":33},"2022-11-01",{"date":92,"type":21},{"name":377,"class":40},"The University of Texas Medical Branch, Galveston",{"id":379,"slug":380,"hasResults":12,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":16,"sex":17,"minAge":385,"maxAge":386,"enrollmentInfo":387,"targetDuration":4,"studyType":54,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":397,"leadSponsor":399,"locationsCount":41},"100599331","effect-of-crown-material-on-gingival-microbial-colonization-100599331","NCT07083102","Effect of Crown Material on Gingival Microbial Colonization","Effect of Crown Material on Gingival Microbial Colonization: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Age between 20 to 50 years.\n* Both male and female patients will be selected.\n* Good oral hygiene (Defined as a plaque index score ≤ 1 across all assessed surfaces and no visible calculus deposits)\n* Dentate patients require fixed prostheses for the first time on mandibular pre-molars and molars.\n* Patient with no history of any dental and bony pathosis (cysts, cancerous lesion).\n\nExclusion Criteria:\n\n* Untreated periodontal diseases\n* Xerostomia\n* Pregnancy, lactation\n* Smokers\n* Individuals with systemic conditions like diabetes and immunosuppressive diseases","20 Years","50 Years",{"count":388,"type":21},30,[107],"* Prior approval from SOD ethical committee has been received.\n* All patients presenting to the General OPD of School of Dentistry, Islamabad will be screened. Those patients who fulfill the criteria will be referred to the Prosthodontics department.\n* The patients will undergo detailed history and oral examination after informed consent (Annexure-A). Patients will undergo radiographic investigation and based on this information they will be selected for the study according to the exclusion and inclusion criteria.\n* Eligible participants will be randomly assigned to one of the following groups using a computer-generated sequence with allocation concealment via sealed opaque envelopes:\n\n  * Group A: Control group\n  * Group B: Full-coverage PFM crowns\n  * Group C: Full-coverage Zirconia crowns\n* Baseline gingival samples will be collected with the help of sterile swab from the target tooth region prior to prosthesis placement and at the follow-up visits i.e. 1, and 3 months; both for experimental groups and control group.\n* Microbial analysis will be conducted through culture techniques to quantify CFUs and identify species.\n* A summary of the micro-organisms, their incubation media, temperature and time is presented in the following table:\n\nTable 1: Summary of the micro-organisms, their incubation media, temperature and time Micro-organism Growth Media Temperature Incubation time Candida albicans Saboraud Agar 370C 24-48 hours Streptococcus mutans BHI broth 370C 24-48 hours Staphylococcus aureus BHI broth 370C 24-48 hours Porphyromonas gingivalis BHI broth 370C 18-24 hours\n\n* Alongside, the same sample from sterile swabs will be smeared by fixating it on a microscopic slide and then Candida albicans will be stained by Periodic Acid Schiff technique, and the bacterial species using Gram staining.\n* All participants will receive standardized verbal and written instructions oral hygiene instructions to control for hygiene-related variation",[28,392],"Missing Teeth","2025-07-16",{"date":395,"type":33},"2025-07-24",{"date":372,"type":21},{"date":398,"type":21},"2025-12-15",{"name":400,"class":401},"Pakistan Institute of Medical Sciences","OTHER_GOV",{"id":403,"slug":404,"hasResults":12,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":54,"phases":410,"briefSummary":411,"conditions":412,"keywords":419,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":67},"100418985","personalized-responses-to-dietary-composition-trial-3-100418985","NCT04735835","Personalized Responses to Dietary Composition Trial 3","Inclusion Criteria:\n\n* Enrolled in the commercial ZOE testing program\n* Any sex\n* Minimum 18 years of age (minimum 19 years of age in Alabama and Nebraska due to state laws)\n* Body mass index (BMI) of greater than or equal to 16.5 kg\u002Fm2.\n* Living in the continental US states, other than in New York (excluded from the ZOE testing product also as they are unable to access the dried blood spot service provided by Quest), or living in the UK\n* Able and willing to comply with the study protocol and provide informed consent.\n* Under care for chronic medical conditions (including eating disorders, type 1 diabetes, type 2 diabetes), and confirm they have checked with their primary care physician that this study is safe for them (US cohort only)\n\nExclusion Criteria:\n\n* Cannot safely eat the pre-made test meals which contain standard US ingredients, e.g. due to allergy or recent gastrointestinal surgery, or are unwilling to consume these foods.\n* Are pregnant.\n* Have had a heart attack (myocardial infarction), stroke\u002Ftransient ischemic attack (TIA), or major surgery in the last two months.\n* Are unable to read and write in English, as the ZOE app is only available in English.",{"count":409,"type":21},250000,[107],"The PREDICT 3 study will build on previous research in over 2,000 individuals to further refine machine learning models that predict individual responses to foods, with the aim of advancing precision nutrition science and individualized dietary advice. The study incorporates both standardized and controlled dietary intervention, for the purpose of testing postprandial responses to specific mixed meals, in addition to a free-living period with a dietary record for measuring responses to a large variety of meals consumed in a realistic context, where the role of external factors (e.g. exercise, sleep, time of day) on postprandial responses may be determined. For the first time this PREDICT study is built on top of a commercial product which will allow access to a much larger group of participants who are already collecting large amounts of data through digital and biochemical devices that can contribute to science.",[413,414,288,415,416,417,418,28],"Diabetes","Heart Diseases","Diet Modification","Healthy","Obesity","Metabolism",[420,421,422,423,424],"Gut microbiome","Personalised nutrition","Machine learning","Postprandial metabolism","Metabolic health","2025-04-11",{"date":427,"type":33},"2025-04-16",{"date":429,"type":33},"2020-07-20",{"date":431,"type":21},"2030-01-01",{"name":433,"class":40},"Zoe Global Limited",{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":16,"sex":17,"minAge":442,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":54,"phases":446,"briefSummary":447,"conditions":448,"keywords":451,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":456,"lastUpdatePostDateStruct":457,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":41},"100558046","gut-microbiota-dependent-health-impacts-of-haskap-berries-100558046","NCT06546020","Gut Microbiota-dependent Health Impacts of Haskap Berries","PARTNERSHIP: Elucidating Gut Microbiota-dependent Health Impacts of Haskap Berries to Inform Agricultural Production Practices That Will Maximize Bioactive Potential","HIH","Inclusion Criteria for Metabolically Healthy Group:\n\nAll of the following:\n\n* Waist circumference: men ≤ 40, women ≤ 35 inches\n* Systolic blood pressure: ≤ 130 mmHg\n* Diastolic blood pressure: ≤ 85 mmHg\n* Fasting glucose: ≤ 100 mg·dl-1\n* Fasting triglycerides: ≤ 150 mg·dl-1\n* HDL: men \\> 40, women \\> 50 mg·dl-1\n\nInclusion Criteria for Metabolically Unhealthy Group:\n\nRequired:\n\n\\- Waist circumference: men ≥ 40, women ≥ 35 inches\n\nAND ≥ 1 of the following:\n\n* Systolic blood pressure: \\> 130 mmHg\n* Diastolic blood pressure: \\> 85 mmHg\n* Fasting glucose: \\> 100 mg·dl-1\n* Fasting triglycerides: \\> 150 mg·dl-1\n* HDL: men ≤ 40, women ≤ 50 mg·dl-1\n\nExclusion Criteria:\n\n* BMI \\\u003C18 or \\> 40 kg\u002Fm\\^2\n* potential allergy to Haskap or placebo ingredients\n* use of anti-inflammatory, lipid lowering, glucose lowering, blood pressure, or any other medications that may interfere with study measures\n* pregnant or lactating woman\n* diagnosis with type 1 or type 2 diabetes or any other condition that may interfere with study measures\n* smoke cigarettes\n* have taken antibiotics in the past 90 days\n* take supplements including pre\u002Fprobiotics or \"superfoods\" within 30 days of starting the study\n* are planning on starting a weight loss or exercise regiment change\n* follow a specific diet such as low carbohydrate, vegan, and vegetarian\n* consume over 5 servings of fruit\u002Fvegetables per day\n* are unwilling to reduce caffeine intake to one 8 oz serving per day for the durations of the study","35 Years","65 Years",{"count":445,"type":21},120,[107],"Polyphenol-rich Haskap berries (Haskap) have untapped therapeutic potential to improve human health, and agricultural producers in northern U.S. states are poised to increase production if consumer demand increases. A critical knowledge gap is that little is known about the interactions between gut microbes and Haskap polyphenols to produce bioactive metabolites linked to downstream health impacts. Additionally, little is known about which Haskap varieties and harvest timing yield the greatest bioactive potential. This study aims to address these gaps by investigating the interaction of bioactive components in Haskap with gut microbiota and the resultant gut and serum metabolites, inflammation, and metabolic health, and then couple this with analysis of berries from different Haskap varieties and harvest times.",[449,450,28],"Metabolic Disease","Inflammation",[452,453,454,455],"Microbial metabolism","Gut microbial composition","Serum metabolome","Polyphenols","2025-04-01",{"date":458,"type":33},"2025-04-02",{"date":460,"type":33},"2025-02-26",{"date":462,"type":21},"2028-05",{"name":464,"class":40},"Montana State University",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":16,"sex":472,"minAge":51,"maxAge":4,"enrollmentInfo":473,"targetDuration":4,"studyType":54,"phases":474,"briefSummary":475,"conditions":476,"keywords":478,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":41},"100513303","the-genital-microbiome-of-male-partners-of-women-with-recurrent-bv-undergoing-vaginal-microbiome-transplantation-100513303","NCT05963711","The Genital Microbiome of Male Partners of Women with Recurrent BV Undergoing Vaginal Microbiome Transplantation","The Penile Microbiome in Partners of Women with Recurrent BV and Its Response to Decolonization Protocol","Inclusion Criteria:\n\n* The subject has s female partner who participates in VMT study ( NCT04517487).\n* The subject is defined by the woman as her male regular partner.\n* Willing to use a condom as instructed by the protocol.\n* Willing to comply with decolonization protocol.\n\nExclusion Criteria:\n\n* A known skin disease involving the penile skin.\n* A known sensitivity to chlorhexidine gluconate\n* Any of the partners (female\u002Fmale) has more than one sexual partner.","MALE",{"count":129,"type":21},[107],"There is strong observational evidence that sexual activity plays a key role in Bacterial Vaginosis (BV) acquisition and recurrence. Microbiological data support the contribution of sexual transmission to the pathogenesis of BV through the exchange of BV-associated bacteria (BVAB) between sexual partners.\n\nAlthough BV epidemiology strongly suggests sexual transmission, treatment of sexual partners is not recommended, based on prior treatment studies of male partners of women with recurrent BV, which showed no benefit with male treatment. Nevertheless, male condom use is highly protective against recurrent BV.\n\nThis study aims to evaluate the male-partner's genital microbiome as a potential source of BV-recurrence in women undergoing vaginal microbiota transplantation (NCT04517487), and whether disinfection can eliminate BV-associated penile microbiome.",[477,28],"Bacterial Vaginosis",[479,480,481,482],"Penile microbiome","Vaginal microbiome transplant","Male partners","Bacterial vaginosis","2025-03-15",{"date":485,"type":33},"2025-03-19",{"date":487,"type":33},"2022-10-17",{"date":489,"type":21},"2026-06",{"name":491,"class":40},"Hadassah Medical Organization",{"id":493,"slug":494,"hasResults":12,"nctId":495,"briefTitle":496,"officialTitle":497,"acronym":498,"eligibilityCriteria":499,"healthyVolunteers":16,"sex":17,"minAge":366,"maxAge":500,"enrollmentInfo":501,"targetDuration":4,"studyType":54,"phases":502,"briefSummary":503,"conditions":504,"keywords":505,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":67},"100479566","effect-of-probiotics-on-infants-fecal-microbiota-composition-100479566","NCT05524649","Effect of Probiotics on Infant's Fecal Microbiota Composition","Safety, Tolerability and Effect on Fecal Microbiota Composition of Two Probiotic Strains in Infants","BABYCARE","Inclusion Criteria:\n\n* Healthy infants\n* Age between 1 and 90 days\n* Gestational age between 37 and 42 weeks\n* Appropiate birth weight for gestational age (between P10 and P90)\n* APGAR test score for birth normal at 1' and 5' of 7-10\n* Whose parents accept the follow-up of the study procedures and sign the informed consent\n\nExclusion Criteria:\n\n* Infants participating in other clinical study\n* Fed with infant formula containing probiotics or other aliments or food supplement based in probiotics 4 weeks prior the start of the study\n* Infants who have taken antibiotics 4 weeks prior the start study\n* Infants with cow's milk protein allergy, lactose intolerance or other digestive diseases\n* Mother's pathological background and during gestation: neurologic disorders, matabolopaties, diabetes mellitus type 1, chronic disease (hypothyroidism), maternal malnutrition\n* Acute congenital or acquired diseases which can interfere with the growth and the normal feeding of the infant\n* TORCH complex infections\n* Every other diseases related with the immune system\n* Parents who can not accomplish the follow-up of the study (medical criterium)","90 Days",{"count":445,"type":21},[107],"Randomized clinical trial to evaluate the effect of two probiotic strains which belong to Bifidobacterium Longum and Pediococcus pentosaceus species on fecal microbiota composition in healthy infants. Secondary outcomes comprise evaluation of anthropometric growth, digestive tolerance, sleeping habits, incidence of functional gastrointestinal disorders, incidence of gastrointestinal and respiratory infections, allergic reactions and safety and tolerability of the product.",[28],[188,506,292],"Infants","2025-02-10",{"date":509,"type":33},"2025-02-11",{"date":511,"type":33},"2022-06-01",{"date":513,"type":21},"2025-12-31",{"name":515,"class":516},"AB Biotics, SA","INDUSTRY",{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":16,"sex":17,"minAge":523,"maxAge":4,"enrollmentInfo":524,"targetDuration":4,"studyType":54,"phases":526,"briefSummary":527,"conditions":528,"keywords":529,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":41},"100560252","transfer-of-microorganisms-between-green-areas-and-humans-100560252","NCT06574724","Transfer of Microorganisms Between Green Areas and Humans","Inclusion criteria:\n\nChildren (min. 4 years old) and adult participants (18+) of any gender in generally good health.\n\nNo strict exclusion criteria will be set in advance.","4 Years",{"count":525,"type":21},150,[107],"The goal of this study is to understand how visiting green areas affects the human microbiome through microbial transfer. Additionally, the project aims to understand which environmental, health and lifestyle factors can influence these microbiome changes. Participants will visit a green area, provide microbiome samples before and after the visit, and complete questionnaires related to environmental, health, lifestyle and demographic factors.",[28],[530,531,85,532,533],"green areas","nature","biodiversity","sequencing","2024-12-03",{"date":536,"type":33},"2024-12-05",{"date":538,"type":33},"2024-08-27",{"date":540,"type":21},"2027-07-07",{"name":542,"class":40},"Universiteit Antwerpen",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":54,"phases":553,"briefSummary":555,"conditions":556,"keywords":559,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":41},"100477854","phase-3-broad-spectrum-antibiotic-prophylaxis-in-tumor-and-infected-orthopedic-surgery-100477854","NCT05502380","Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery","Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Sur-gery - the Prospective-randomized, Microbiologist-blinded, Stratified, Superiority Trials - BAPTIST Trials","BAPTIST","Inclusion Criteria\n\n* Age ≥ 18 years\n* Surgery under current or recent therapeutic antibiotics (antibiotic-free window \\\u003C14 days and past antibiotic prescription \\>4 days)\n* Surgery for open fractures and wounds; including 2nd and 3rd looks\n* Potentially contaminated wound revision in the operating theatre\n* Tumor (oncologic) surgery (if prior radiotherapy and\u002For bone involvement)\n* Spine surgery with ASA-Score \\>= 3 points, sacral involvement, or re-vision surgery\n* Known skin colonization with multidrug-resistant Gram-negative bacteria\n\nExclusion Criteria:\n\n* Inability to understand the study procedure for linguistic or cognitive rea-sons\n* Surgery without intraoperative microbiological samples\n* Allergy or major intolerance to vancomycin and\u002For gentamicin\n* Anticipated clinical follow-up of less than 6 weeks after inclusion\n* Pregnant or breastfeeding women\n* Known carriage of multiresistant Gram-negative bacteria in the urine or anal region",{"count":552,"type":21},1100,[554],"PHASE3","The perioperative antibiotic prophylaxis is evidence-based in orthopedic surgery. While its duration ranges from a single dose to three doses throughout the world, the choice of the prophylactic agents is undisputed. Worldwide, the surgeons use 1st or 2nd-generation cephalosporins (or vancomycin in some cases).\n\nHowever, there are particular clinical situation with a high risk of antibiotic-resistant surgical site infections (SSI); independently of the duration of adminis-tered prophylaxis. These resistant SSI's occur in contaminated wounds, or during surgery under current therapeutic antibiotics, and base on \"selection\" by antibiotics used for therapy or for prophylaxis.",[557,28,558],"Surgical Site Infection","Antibiotic Resistant Infection",[560,561,562,563],"Perioperative antibiotic prophylaxis","Selection","High Risk patients","Ranndomized-Controlled Trial","2024-11-28",{"date":566,"type":33},"2024-12-02",{"date":568,"type":33},"2022-09-15",{"date":570,"type":21},"2025-12-12",{"name":572,"class":40},"Balgrist University Hospital",{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":16,"sex":50,"minAge":51,"maxAge":151,"enrollmentInfo":580,"targetDuration":4,"studyType":54,"phases":581,"briefSummary":582,"conditions":583,"keywords":587,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":41},"100472475","esan-ii---energy-sensing-in-depression-100472475","NCT05432362","ESAN II - Energy Sensing in Depression","ESAN II - Energy Sensing in Depression. Effects of Aronia Melanocarpa on Immunomodulation in Patients With Obesity, Depression, and Normal Weight Controls.","Inclusion Criteria:\n\n1. Socio-demographic criteria:\n\n   1. Gender: female\n   2. Age: 18-40 years\n2. Confirmation of the study settings\n\n   1. receives of information on\n\n      * the aims,\n      * methods,\n      * anticipated benefits,\n      * potential risks, and\n      * entailed discomforts of the study\n   2. signed declaration of consent\n3. Subgroup of depressive patients:\n\n   1. diagnosis of depression according to the ICD-10 criteria for depression\n   2. diagnosed by an experienced psychiatrist\n\n      * a structured diagnostic interview\n      * voluntarily agreement to participate\n      * signed informed consent\n4. Subgroup of normal weight participants:\n\n   * WHO criteria for normal weight (body mass index (BMI) 18.5-24.99 kg\u002Fm2)\n5. Subgroup of obese participants\n\n   * WHO criteria for obesity (BMI \\\u003C 30.0 kg\u002Fm2)\n\nExclusion Criteria:\n\n1. Formal criteria:\n\n   * lack of informed consent\n2. Health criteria\n\n   1. alcohol- or drug abuse\n   2. major cognitive deficits (which do not allow adequate testing)\n\n      * according to Mini Mental Status Examination (MMSE) \\\u003C20\n   3. patients which are currently in the locked ward of the clinic\n   4. acute or chronic diseases or infections within the previous two months\n\n      * upper respiratory tract infections\n      * fever\n      * chronic inflammatory disorders\n      * autoimmune-disorders\n      * blood diseases\n      * mitochondrial diseases\n3. Digestive disorders\n\n   1. fructose intolerance\n   2. history of digestive diseases such as\n\n      * inflammatory bowel disease\n      * irritable bowel syndrome\n   3. treatment that may has influenced the microbiome\n\n      * antibiotic or antifungal treatment within the previous two months\n      * daily or irregular intake of prebiotics or probiotics within the previous two months (the intake of yoghurt and dairy products are permitted)\n   4. history of gastrointestinal surgery (other than appendectomy)\n4. Pregnancy and period of breastfeeding",{"count":445,"type":21},[107],"The purpose of this study is to assess the effects of polyphenols from natural aronia juice on the immune system.\n\nTherefore, the study aims to distinguish the effects of natural juices that are rich in phytonutrients such as polyphenols and carotenoids in healthy and depressive subjects in order to use the known positive effects of these food sources in the therapeutic setting.\n\nThe consumption of natural fruit juices that are rich in polyphenols and carotenoids mirror a model of vegetarian diet due to the increased micronutrient density derived from plant food. Results obtained here can be seen as preliminary explanation models for the beneficial effects of vegetarian diet.\n\nIt is hypothesized, that the consumption of naturally polyphenol rich aronia juice changes the expression of regulatory T cells, specific cells of the immune system that contribute to immunomodulation. Furthermore, beneficial changes in the gut microbiome, the metabolome and the nutritional status are expected in the studied groups.\n\nThe study was registered retrospectively (after start of recruitment) on Clinicaltrials.gov.",[584,585,417,28,586],"Immune System Tolerance","Depression","Diet, Healthy",[588,589,590,591,592],"polyphenols","Aronia melanocarpa","immunomodulation","plant based food","natural food","2024-11-25",{"date":595,"type":33},"2024-11-27",{"date":597,"type":33},"2019-02-25",{"date":599,"type":21},"2026-01-31",{"name":601,"class":40},"Medical University of Graz",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":4,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":50,"minAge":51,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":612,"conditions":613,"keywords":615,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":41},"100426738","microbiome-and-polycystic-ovaries-100426738","NCT04836910","Microbiome and Polycystic Ovaries","The Change in Microbiome Following Treatment of Women With Polycystic Ovaries","Inclusion Criteria:\n\nStudy group: Untreated women diagnosed with PCOS that are planned for intervention.\n\nControl group: Women without PCOS visiting the gynecologic outpatient's clinics.\n\nExclusion Criteria:\n\n1. Endocrine abnormality ( Cushing's syndrome, congenital adrenal hyperplasia, thyroid disorder, hyperprolactinemia and androgen-secreting tumor).\n2. Premature ovarian failure 2. Active malignancy 3. Participants taking antibiotics\u002F probiotics, hormonal, vaginal or laxative medicine (in the previous week).\n\n4\\. Vaginitis\u002F Pelvic Inflammatory Disease (PID)","42 Years",{"count":611,"type":21},40,"Polycystic Ovary Syndrome (PCOS) is the most common endocrine disorder among women in reproductive age with an estimated prevalence of 5% to 19.5%. It is a chronic complex syndrome with psychological (depression and anxiety), reproductive and metabolic abnormalities. The etiology seems to be multifactorial. Lately, interest regarding the association between PCOS women and gut macrobiotic have been emerged. Hyperandrogenism was correlated with those changes in the microbiota which reflects the fact that the microbiome can influence the development and pathology of PCOS .\n\nTherefore, aim of this study is to explore the diversity and alternations of the vaginal and the gut microbiome in patients with PCOS during common therapeutic interventions and connect them to different phenotypes of the syndrome.",[614,28],"Polycystic Ovary Syndrome",[616],"polycystic ovaries, microbiome","2024-11-12",{"date":619,"type":33},"2024-11-14",{"date":621,"type":21},"2025-09-01",{"date":623,"type":21},"2027-03-30",{"name":625,"class":401},"Sheba Medical Center",{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":630,"acronym":631,"eligibilityCriteria":632,"healthyVolunteers":16,"sex":50,"minAge":51,"maxAge":633,"enrollmentInfo":634,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":636,"conditions":637,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":41},"100396871","bern-birth-cohort--trajectory-of-microbiota-maturation-in-healthy-bern-infants---a-network-approach-100396871","NCT04447742","Bern Birth Cohort \u002F Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach","BeBiCo","Inclusion Criteria:\n\n* Signed informed consent.\n* Ability to understand and follow study procedures and understand informed consent\n* From week 20 of pregnancy until birth\n* General good health, i.e. absence of major severe medical\u002F surgical\u002F psychiatric condition requiring ongoing management. Minor well controlled conditions (e.g. medically controlled arterial hypertension, occupational asthma, gestational diabetes mellitus) may be present.\n* Absence of known severe embryonal pathology, expected normal pregnancy (e.g. minor conditions including twin\u002F triplet pregnancy, final pelvic position may be present)\n* Age 18-45 years.\n\nExclusion Criteria:\n\n• Participation in another clinical study interfering with study procedures.","45 Years",{"count":635,"type":21},250,"Background: Intestinal microbiota composition is fundamental to human health and undergoes critical changes within the first two years of life. Factors probably influencing the microbiota are the maternal microbiota and the general environment in Switzerland. However, the development of the intestinal microbiota is incompletely understood. Gaining knowledge of the trajectory of microbiota maturation is likely key to the understanding of the pathogenesis of many pathologies in childhood.\n\nAims: The investigators aim for a deep understanding of the maturation of the healthy infant intestinal microbiota regarding composition, diversity and metabolic activities. The investigators aim for identifying parameters affecting microbiota maturation and effects of the microbiota on infant outcome.\n\nMethods: The investigators will recruit 250 pregnant mothers who will be followed as mother-baby pairs until 10 years of age. Infants will be followed clinically to determine adequate growth and development as well as pathology including abdominal pain. Epidemiological parameter and infant nutrition will be assessed. The investigators will collect biological samples such as stool, maternal milk, vaginal swaps and skin swaps.\n\nSpecies composition and diversity will be assessed by 16S sequencing. Metagenomic shotgun sequencing and bacterial messenger ribonucleic acid (mRNA) analysis will inform about metabolic potential and metabolic activity of the microbiota. Mass spectrometry will assess the small molecule content of stool and maternal milk samples. Network analysis will be used to assess the complex relationships between bacteria metabolic activities and small molecular content.\n\nExpected results: The investigators expect an increase in complexity and metabolic potential and activity with age. Microbiota parameters will differ according to nutrition and might predict infant outcomes such as growth and abdominal pain. Systematic analysis of sequential maternal and infant bacteria samples from stool, skin and maternal milk will help characterizing bacterial transfer from mother to infant Conclusion: The investigators propose an observational study of healthy Bern mother baby pairs with clinical characterisation and biological sampling. Advanced analysis tools will be used to characterise the microbiota and address mechanistic questions.",[638,28,639,640,641],"Maturation of the Healthy Infant Intestinal Microbiota","Nutrition Disorder, Infant","Milk Expression, Breast","Mental Health Disorder","2024-11-11",{"date":617,"type":33},{"date":645,"type":33},"2020-05-07",{"date":647,"type":21},"2035-03-03",{"name":649,"class":40},"Insel Gruppe AG, University Hospital Bern",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":16,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":657,"targetDuration":4,"studyType":54,"phases":659,"briefSummary":660,"conditions":661,"keywords":667,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":675,"locationsCount":41},"100461493","efficacy-of-the-vacucis-candida-autovaccine-100461493","NCT05289375","Efficacy of the Vacucis Candida® Autovaccine","Efficacy of the Vacucis Candida® Autovaccine in the Management of Chronic Oral Candidiasis. Randomized Triple-blind Randomized Clinical Trial.","Inclusion Criteria:\n\n* Patients with a history of RT in the head and neck region that directly or indirectly involves any of the jaws.\n* Adult patients\n* Hemodynamically stable patients without contraindications to receive an autovaccine (see exclusion)\n* Patients with a stable oncological situation without active tumor\n* Patients who present candidiasis demonstrated by clinical examination (signs and symptoms of candidiasis) and microbiological (culture).\n\nExclusion Criteria:\n\n* Minor patients\n* Pregnant patients\n* Patients with an unstable medical situation, both from a hemodynamic and oncological point of view (advanced tumors with metastases, recurrences or inoperable tumors)\n* Patients undergoing treatment with CT that involves an affectation of the immune system\n* Patient under treatment with antifungals for mycoses of any origin\n* Allergy to the active substance or to any of the other components of Vacucis.\n* Serious disorders of the immune system.\n* Diseases that severely affect immunity.\n* Presence of fever.\n* People with allergies to yeasts\n* People with allergy to chloramphenicol\n* Patients treated with MAOIs (monoamine oxidase inhibitors)",{"count":658,"type":21},46,[107],"Introduction: Oral candidiasis is an infectious disease caused by the growth of Candida colonies and their penetration into oral tissues when physical barriers and host defenses are weakened. It constitutes one of the most common pathologies within the field covered by Dentistry. Candida infections are found in at least 80% of AIDS patients and in a third of HIV infection cases. Systemic diseases such as diabetes and a wide pharmacological arsenal to which the general population is subjected, are other causes of the increase in the prevalence of this disease. In addition, the high prevalence of oral sequelae (hyposialia) in the population over 65 years of age, due to the specific characteristics of this age group, such as multiple pathologies and drug use, explains the presence of this disease in this segment. of the population One of the great difficulties for the study of this disease is the diversity of predisposing factors, which do nothing but throw greater confusion into the results of the different works.\n\nObjective: To evaluate the reduction\u002Fsuppression of signs and symptoms of oral candidiasis in patients treated with head and neck RT, users of Vacucis or Placebo.\n\nMaterial and method: Patients will receive information regarding the trial and, if they meet the inclusion criteria and agree to participate in it, they will sign the informed consent. All patients will be informed following the usual care practice of the characteristics of their candidiasis infection as well as the possibilities and alternatives of treatment and their respective efficacy.\n\nA descriptive analysis of the sample in terms of prevalence will be carried out. Categorical variables will be described as frequency and percentage and continuous variables as mean and standard deviation or median and interquartile range depending on their adjustment to normality, which will be calculated with the Kolmogorov-Smirnov test. To study the effect of the vaccine on the evolution of candidiasis, the Chi-square test, Student's t test or the non-parametric Mann-Whitney test will be used. The association of prevalence with CFU in both groups will be analyzed using the ANOVA test. Those values of p \\\u003C 0.05 will be considered significant.",[662,663,664,665,28,666],"Oral Candidiasis","Oral Candidiasis Recurrent","Radiotherapy; Complications","Candida Albicans Infection","Xerostomia",[668],"oral candidiasis","2024-10-15",{"date":671,"type":33},"2024-10-17",{"date":673,"type":21},"2025-04-30",{"date":119,"type":21},{"name":676,"class":40},"University of Santiago de Compostela"]