[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dysbiosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dysbiosis":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,23,0,[8,45,70,110,134,164,194,231,255,285,321,364,392,437,462,489,513,545,573,601,632,670,700],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100645274","metabolic-and-functional-study-of--t-cells-in-critically-ill-patients-100645274",false,"NCT07680816","Metabolic and Functional Study of γδ T Cells in Critically Ill Patients","Subset-specific Metabolic Adaptation and Functional Remodeling of Gamma Delta T (γδ T) Cells in Critically Ill ICU Patients: A Single-center, Prospective, Observational Cohort Study.","Inclusion Criteria:\n\n1. Healthy Control Group (NHC):\n\n   * Age ≥ 18 years.\n   * No acute or chronic major diseases.\n   * Provide written informed consent.\n2. Non-septic Critical Illness Group (CI-NS):\n\n   * Age ≥ 18 years.\n   * Admitted to the ICU and meeting the definition of critical illness.\n   * Excluded from sepsis according to the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).\n   * Written informed consent provided by the participant or legally authorized representative.\n3. Septic Critical Illness Group (CI-Sep):\n\n   * Age ≥ 18 years.\n   * Admitted to the ICU and meeting the Sepsis-3 criteria (infection + ΔSOFA ≥ 2 points).\n   * Written informed consent provided by the participant or legally authorized representative.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Known immunodeficiency, HIV infection, active hematologic malignancy, or history of hematopoietic stem cell or solid organ transplantation within the past 3 months.\n* Receipt of T-cell-targeted immunosuppressive therapy (e.g., antithymocyte globulin, calcineurin inhibitors, mycophenolate mofetil, methotrexate, or high-dose corticosteroids \\>1 mg\u002Fkg\u002Fday prednisone equivalent) before ICU admission or within 24 hours after ICU admission.\n* Use of immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1\u002FCTLA-4 antibodies) within the past 6 weeks.\n* Expected ICU stay \\\u003C 24 hours or imminent risk of death (moribund state).\n* Pregnancy or breastfeeding.\n* Active major bleeding.\n* Inability to obtain informed consent.",true,"ALL","18 Years","80 Years",{"count":21,"type":22},105,"ESTIMATED","OBSERVATIONAL","This prospective observational cohort study investigates the subset-specific metabolic adaptation and functional remodeling of cytotoxic γδT cells in critically ill patients with and without sepsis. Emerging evidence indicates that γδT cells, as a bridge between innate and adaptive immunity, play a critical role in early anti-infection defense during sepsis. However, the functional status and underlying regulatory mechanisms of cytotoxic γδT cells in septic patients remain incompletely understood. Our preliminary single-cell transcriptomic analysis revealed that cytotoxic γδT cells from septic patients exhibit significant alterations in cytotoxicity-associated molecules (GZMB, PRF1, GNLY) and mitochondrial oxidative phosphorylation (OXPHOS) pathway genes, particularly COX6C, which correlates with cytotoxic effector molecule expression. This study aims to systematically characterize the proportion, cytotoxicity, and mitochondrial metabolic function of circulating cytotoxic γδT cells across three cohorts: healthy controls, critically ill non-septic patients, and critically ill septic patients. By integrating flow cytometry, mitochondrial function assays, and functional validation experiments, we seek to elucidate the role of COX6C-mediated mitochondrial metabolic abnormalities in cytotoxic γδT cell dysfunction, providing theoretical basis for understanding immune dysregulation in sepsis and identifying novel therapeutic targets.",[26,27,28,29,30,31,32],"Sepsis","Critical Illness","Immunosuppression","MODS","Mitochondrial Diseases","Dysbiosis","γδ T Cells","NOT_YET_RECRUITING","2026-07-01",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":22},"2026-07-15",{"date":41,"type":22},"2027-07-15",{"name":43,"class":44},"Union Hospital, Tongji Medical College, Huazhong University of Science and Technology","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":4},"100644582","fmt-for-90-day-outcome-of-clinical-use-in-icu-sepsis-100644582","NCT07670299","FMT for 90-Day Outcome of Clinical Use in ICU Sepsis","Fecal Microbiota Transplantation for 90-Day Outcome of Clinical Use in ICU Sepsis: a Single-Center, Open-Label, Randomized Controlled Trial","FOCUS","Inclusion Criteria:\n\n* Age ≥ 18 years, any ethnicity, any gender.\n* Diagnosis of sepsis according to the Sepsis-3 criteria (infection with an acute change in SOFA score ≥ 2 points).\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Patients whom the attending clinician considers to have a high risk of death within 5 days, or patients with treatment limitations in place.\n* Active major gastrointestinal bleeding, perforation, or other severe impairment of the intestinal barrier.\n* Patients unable to tolerate enteral nutrition meeting ≥50% of caloric requirements due to severe diarrhea, significant fibrotic intestinal stricture, severe gastrointestinal bleeding, or high-output intestinal fistula.\n* Planned or recent abdominal surgery (within 14 days).\n* Current diagnosis of fulminant colitis or toxic megacolon.\n* Recent receipt of high-risk immunosuppressive or cytotoxic therapy, such as rituximab, doxorubicin, or moderate-to-high-dose corticosteroids (≥20 mg\u002Fday of prednisone or equivalent) for more than 4 consecutive weeks.\n* Pregnant or breastfeeding women.\n* Participation in another clinical trial as a subject at the time of enrollment or within 3 months prior to enrollment.\n* Subjects for whom the validity of informed consent is questionable, including those with psychiatric disorders, intellectual disability, poor motivation, or other conditions that may limit their ability to provide informed consent.","70 Years",{"count":55,"type":22},60,"INTERVENTIONAL",[58],"NA","Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection, representing one of the leading causes of death in intensive care units (ICUs) worldwide. Gut microbiota disruption is increasingly recognized as a key driver of persistent inflammation and multiple organ dysfunction in septic patients. Fecal microbiota transplantation (FMT) has emerged as a promising approach to restore gut microbial homeostasis. This study hypothesizes that FMT acts not through long-term engraftment of donor microbes, but via a \"functional pulse\" - a potent, transient biological intervention that delivers high-dose microbial metabolites (e.g., short-chain fatty acids), competitively inhibits pathogens, and rapidly modulates intestinal immune cell functions.\n\nThis is a single-center, open-label, randomized controlled trial conducted in the ICU of Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. A total of 60 adult patients diagnosed with sepsis according to Sepsis-3 criteria within 24 hours of ICU admission will be randomized in a 1:1 ratio to receive either ICU standard care alone (control group) or ICU standard care plus FMT administered via a nasojejunal tube for three consecutive days (intervention group). The primary endpoint is all-cause mortality at 90 days. Secondary endpoints include ICU mortality, in-hospital mortality, 28-day mortality, changes in gut microbiota composition and metabolites, serum citrulline levels as a marker of intestinal barrier function, Sequential Organ Failure Assessment (SOFA) and Acute Physiology and Chronic Health Evaluation II (APACHE II) scores, vasopressor requirements, C-reactive protein and procalcitonin levels, fluid balance, incidence of ICU delirium and feeding intolerance, and 90-day hospital readmission rate. Safety outcomes include gastrointestinal symptoms and transient fever.",[26,27,61,31,62],"Gastrointestinal Dysfunction","Fecal Microbiota Transplantation","2026-06-25",{"date":65,"type":37},"2026-06-26",{"date":39,"type":22},{"date":68,"type":22},"2028-10-15",{"name":43,"class":44},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":16,"sex":17,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":56,"phases":80,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100642187","pulse-education-and-children-100642187","NCT07648446","Pulse Education and Children","Enhancing Dietary Perception and Acceptance of Pulses in Children Through an Innovative Nutritional Intervention Program: Bringing Pulses to the Dining Table","Inclusion Criteria:\n\n* Children aged 6-13 years old\n* Ability to speak English\n\nExclusion Criteria:\n\n* Frequent pulse consumers (\\>0.5 cup\u002Fweek for females and \\>1 cup \u002F week for males)\n* Antibiotic use in the past 3 months\n* Diagnosed metabolic\u002Fgut diseases (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C \\> 9%).\n* Current use of medications or nutrition supplements\n* Individuals following a specific dietary patten\n* Individuals who gained or lost \\>5% body weight within the past 6 months\n* Those involved in another study concurrently\n* Any allergies to pulses\n* Intake of pre\u002Fpro\u002Fpostbiotics in the past 3 months","6 Years","13 Years",{"count":55,"type":22},[58],"This parallel-arm, randomized controlled trial will evaluate the effectiveness of a 6-week pulse-focused nutrition intervention in school-aged children (6-13 years). The study aims to assess adherence to a pulse-based diet providing 1.5 cups of pulses per week and to examine the effects of whole-cooked pulse consumption on gut health, including gut microbiome composition, metabolomic profiles, and gut barrier function. Secondary objectives include evaluating the impact of pulse consumption on markers of metabolic health and inflammation. Forty participants will be randomized to either a pulse-focused nutrition education program with weekly provision of pre-measured pulses (black beans, lentils, and chickpeas) or a pulse-focused nutrition education program in which participants independently procure their own pulses. Participants will follow the assigned intervention for 6 weeks.",[31,83,84,85],"Cardiometabolic Health Indicators","Education on Feeding and Health Status","Gut Motility",[87,88,89,90,91,92,93,94,95,96,97,98],"gut","git microbiome","children","pediatric","pulses","beans","metabolomics","nutrition education","dietary adherence","fiber inake","plant-based","pulse consumption","RECRUITING","2026-06-11",{"date":102,"type":37},"2026-06-15",{"date":104,"type":22},"2026-08-01",{"date":106,"type":22},"2028-12-31",{"name":108,"class":44},"Florida State University",1,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":16,"sex":17,"minAge":77,"maxAge":78,"enrollmentInfo":117,"targetDuration":4,"studyType":56,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":132,"leadSponsor":133,"locationsCount":109},"100642795","almonds-gut-microbiome-and-kids-100642795","NCT07636850","Almonds, Gut Microbiome and Kids","Nutritional Impact of Almond Butter on Gut Microbiome and Cardiometabolic Health in School-Aged Children: A Novel and Timely Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Enrolled in elementary or middle school (grades 1-8)\n* Aged 6-13 years old\n* Ability to speak and read in English\n\nExclusion Criteria:\n\n* Intake of antibiotics in the last 3 months\n* Intake of pre\u002Fpro\u002Fpostbiotics in the last 3 months\n* Food allergy to study foods\n\n  ◦ Any allergy to nuts or almonds\n* Any allergy to the isocaloric snack (chocolate or wheat)\n* Regular consumption of nuts or almonds greater than 2 servings \u002F week\n* Gastrointestinal disease (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C \\> 9%).",{"count":118,"type":22},70,[58],"This 8-week parallel-arm randomized controlled trial (N=70; ages 6-13) will determine the impact of daily almond butter consumption on gut microbiome composition and function, intestinal barrier integrity, and cardiometabolic health in school-aged children. Participants will be randomized to either a once-daily snack of personalized-portion almond butter (ALB; 16g, Creamy Natural Almond Butter) or an isocaloric nut-free chocolate spread control (CTL; 16g, Cadbury Milk Chocolate), each served on two plain unsalted saltine crackers, added to their habitual diet. The primary outcomes include oro-gut microbial composition and diversity, gut microbial functional capacity and metabolomics (SCFAs, bile acids, amino acid metabolites), and intestinal barrier integrity. Secondary outcomes include fasting cardiometabolic markers, systemic inflammation, appetite-regulatory and metabolic hormones, and sleep-related biomarkers. Feasibility, adherence (weekly logs; serum α-tocopherol), and precision nutrition potential will also be assessed, with stratified analyses by age, sex, BMI, ethnicity, and pubertal stage.\n\nThis pilot trial will generate the first multi-omics characterization of almond butter's effects on the gut-immune-metabolic axis in children.",[31,83],[87,123,89,90,124,125,126,127,93],"gut microbiome","sleep quality","almonds","nuts","almond butter","2026-06-05",{"date":130,"type":37},"2026-06-09",{"date":104,"type":22},{"date":106,"type":22},{"name":108,"class":44},{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":17,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":56,"phases":145,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":109},"100640203","probiotics-supplementation-for-neurodevelopment-in-preterm-infants-100640203","NCT07617181","Probiotics Supplementation for Neurodevelopment in Preterm Infants","Effect of Gut Microbiota Remodeling Via Probiotics Supplementation on Neurodevelopment in Preterm Infants: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Preterm infants with a gestational age between 28 and 37 weeks (inclusive of 28 weeks)\n* Documented history of neonatal intravenous antibiotic exposure for at least 5 consecutive days during the neonatal period (e.g., in the NICU).\n* Corrected age of 6 months ± 7days at the time of enrollment.\n* No systemic antibiotic usage within 14 days prior to screening.\n* Legal guardians are willing to sign the informed consent form and comply with the 6-month intervention and follow-up schedule.\n\nExclusion Criteria:\n\n* Severe congenital malformations, chromosomal abnormalities, or inherited metabolic diseases (e.g., Down syndrome).\n* Severe neurological disorders or structural brain injuries (e.g., Grade III\u002FIV intraventricular hemorrhage, cystic periventricular leukomalacia, or hydrocephalus requiring a shunt).\n* Severe chronic diseases affecting growth and development (e.g., congenital heart disease requiring surgery, short bowel syndrome, or severe sequelae of necrotizing enterocolitis).\n* Concurrent participation in other interventional clinical trials.\n* Planned long-term use of other commercial probiotic\u002Fprebiotic supplements outside the study protocol during the intervention period.\n* High risk of loss to follow-up (e.g., expected relocation).","23 Weeks","25 Weeks",{"count":144,"type":22},116,[58],"The purpose of this randomized controlled trial is to evaluate the effect of daily supplementation with a probiotic mixture on the neurodevelopmental outcomes of preterm infants with a history of neonatal antibiotic exposure. The intervention lasts for 6 months. The study hypothesizes that early gut microbiota remodeling via exogenous probiotics can improve neurodevelopment. The primary outcome is assessed by the Gesell Developmental Schedules or the Ages \\& Stages Questionnaires (ASQ-3). Secondary outcomes include longitudinal changes in gut microbiota composition,targeted metabolomics (such as short-chain fatty acids \\[SCFAs\\], and systemic inflammatory markers.",[148,149,31],"Premature Birth","Neurodevelopmental Disorders",[151,152,153,154],"Probiotics","Gut-Brain Axis","Neonatal Antibiotic Exposure","Preterm Infants","2026-05-23",{"date":157,"type":37},"2026-06-01",{"date":159,"type":22},"2026-06",{"date":161,"type":22},"2027-12",{"name":163,"class":44},"Fudan University",{"id":165,"slug":166,"hasResults":11,"nctId":167,"briefTitle":168,"officialTitle":169,"acronym":170,"eligibilityCriteria":171,"healthyVolunteers":16,"sex":17,"minAge":172,"maxAge":53,"enrollmentInfo":173,"targetDuration":4,"studyType":56,"phases":175,"briefSummary":176,"conditions":177,"keywords":182,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":109},"100557964","prebiotic-effects-of-california-grapes-on-gut-health-and-cardiometabolic-health-in-overweight-men-and-women-100557964","NCT06544954","Prebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women","Assessing Prebiotic Effect of California Grape Consumption on Gut Microbiome and Impact on Intestinal Permeability, Vascular Function, and Systemic Inflammation in Over-weight Subjects: Differences in Effects Between Men and Women","CALGRAM","Inclusion Criteria:\n\n* post-menopausal women (cessation of menstruation for minimum two years)\n* overweight and obese (BMI between 25-35 kg\u002Fm2)\n* stable treatment for type 2 diabetes or metabolic syndrome\n* ability to understand the intervention concept and written consent to participate\n* willingness to accept randomization, undergo testing and intervention procedures, and deliver stool and blood samples\n\nExclusion Criteria:\n\n* menopausal hormone replacement therapy started within less than 6 months\n* antibiotics, prebiotics within last 3 months\n* antidiabetic treatment involving insulin (for type 1 diabetes)\n* vegetarian\u002Fvegan and not able to follow modified diet\n* any serious medical condition including but not limited to coronary artery disease, uncontrolled hypertension, stroke, congestive heart failure, insulin-dependent diabetes, liver disease, active cancer and anemia\n* psychiatric disease that interferes with the understanding and implementation of the intervention\n* history of eating disorders such as bulimia nervosa, anorexia nervosa, severe binge eating disorder in the last 5 years\n* history of substance abuse or alcohol abuse\n* involvement in a weight loss intervention program (including anti-obesity medication) within last 3 months or have had bariatric surgery\n* current smokers (within last 180 days)\n* use of dietary supplements containing polyphenols in the past 1 month\n* strenuous exercise greater than 10 hours per week","45 Years",{"count":174,"type":22},40,[58],"The goal of this clinical trial is to assess the impact of table grape consumption on gut microbiome, intestinal permeability, systemic inflammation, and vascular function in healthy overweight men and women aged 45-70 years. The main questions it aims to answer are:\n\n* Does daily grape intake alter intestinal microbiome composition and intestinal permeability?\n* Are changes in gut microbiota and intestinal permeability correlated with changes in cardiometabolic risk factors (inflammation, vascular function, lipid profiles)?\n* Does response to grape intake on gut microbiota, intestinal permeability, cardiometabolic and inflammatory markers differ between men and women?\n* Are metabolic pathways modified by grape consumption able to explain the link between gut health and cardiometabolic factors?\n\nResearchers will compare freeze-dried grape powder to placebo powder to see if grape powder improves cardiometabolic risk factors.\n\nParticipants will\n\n* Consume the powder dissolved in water twice daily for 3 weeks\n* Follow their usual diet, modified to limit polyphenol-rich foods\n* Visit the clinic at the beginning and end of the intervention for vascular measurements and blood sample collection\n* Complete a 3-day 24-hour dietary recall and collect stool sample before each visit",[178,179,31,180,181],"Arterial Stiffness","Blood Pressure","Inflammation","Permeability; Increased",[123,183,184],"nutrition","cardiometabolic health","2026-04-10",{"date":187,"type":37},"2026-04-13",{"date":189,"type":37},"2025-05-07",{"date":191,"type":22},"2027-01",{"name":193,"class":44},"University of California, Davis",{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":16,"sex":202,"minAge":18,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":206,"conditions":207,"keywords":215,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":109},"100608318","impact-of-internal-menstrual-protections-on-immunity-and-vaginal-microbiota-100608318","NCT07199998","Impact of Internal Menstrual Protections on Immunity and Vaginal Microbiota","Impact of the Use of Internal Menstrual Protections on Immunity and Vaginal Microbiota","CUPS2","Inclusion Criteria:\n\n* Willingness to comply with all study procedures and availability for the duration of the study.\n* Female, aged 18 to 49 years.\n* In general good health, as determined by medical history.\n* Covered by the national health insurance system.\n* Willing to sign a written informed consent form.\n* Has already experienced menstruation prior to the start of the study.\n* No vaginal sexual intercourse within 72 hours before the study visit.\n* Has had at least 6 menstrual periods in the past 12 months.\n\nExclusion Criteria:\n\n* HIV infection.\n* Positive diagnosis for chlamydia or syphilis at screening or within 4 weeks prior to screening.\n* History of hormonal disorders or menstrual cycle irregularities.\n* Metrorrhagia.\n* Pregnancy or breastfeeding.\n* Family members or close relatives of the clinical or scientific team.\n* Treatment with any medication for chronic inflammatory disease or chronic conditions (e.g., cancer, arthritis, transplantation) within the past 12 months.\n* Participation in an ongoing clinical trial.\n* Receiving or having received antibiotic treatment within the 4 weeks prior to the study.\n* Refusal to be informed in case of detected abnormalities.\n* Indistinct use of both tampons and menstrual cups.\n* Never having had vaginal penetrative intercourse.","FEMALE","49 Years",{"count":205,"type":22},300,"The availability, effectiveness, and safety of menstrual protection represent a key public health issue. However, research on women's menstrual and sexual health remains extremely limited. Whether societal or pathological, many hypotheses are emerging regarding the effects of menstrual protection products, yet little attention has been given to the products themselves, their societal role, or their physiological and pathological consequences. Internal menstrual products, such as tampons and menstrual cups, are widely used but are subject to limited regulatory oversight, and few studies have investigated their long-term effects on vaginal health.\n\nThis study aims to investigate how different types of menstrual protection influence vaginal microbiota, immune responses, and the recurrence of gynecological conditions such as bacterial vaginosis, mycosis, or dysbiosis. Biological samples (vaginal, cervical, urinary, and blood) will be collected to analyze vaginal microbiota composition and local immunity. Participants will be divided into three groups based on their main type of menstrual protection: menstrual cup users, tampon users, and external pad users. The study will compare these groups to assess potential differences in vaginal health and immune response related to menstrual product use.",[208,209,210,211,212,31,213,214],"Sexual Transmitted Disease","Vaginosis, Bacterial","Mycosis","Urogenital Disease","HPV","Toxic Shock Syndrome","Menstrual Cup",[216,31,217,218,219,220,221],"Menstrual cup","Menstrual health","Menstrual protection","Menstrual pad","Tampon","Immunity","2026-04-08",{"date":224,"type":37},"2026-04-09",{"date":226,"type":37},"2026-04-07",{"date":228,"type":22},"2027-03",{"name":230,"class":44},"Centre National de la Recherche Scientifique, France",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":16,"sex":17,"minAge":77,"maxAge":78,"enrollmentInfo":238,"targetDuration":4,"studyType":56,"phases":239,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":249,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":109},"100586558","effect-of-peanut-butter-on-gut-and-metabolic-health-100586558","NCT06916936","Effect of Peanut Butter on Gut and Metabolic Health","Effect of Peanut Butter on Gut and Metabolic Health in School-Aged Children","Inclusion Criteria:\n\n* Enrolled in elementary or middle school (grades 1-8)\n* Aged 6-13 years old\n* Ability to speak and read in English\n\nExclusion Criteria:\n\n* Intake of antibiotics in the last 3 months\n* Intake of pre\u002Fpro\u002Fpostbiotics in the last 3 months\n* Food allergy to study foods\n\n  * Any allergy to nuts or peanuts\n* Any allergy to the isocaloric snack (chocolate or wheat)\n* Regular consumption of nuts or peanuts greater than 2 servings \u002F week\n* Gastrointestinal disease (ulcerative colitis, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome, irritable bowel syndrome, gastroesophageal reflux disease), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C \\> 9%).\n* Known to be pregnant (self-disclosed)",{"count":55,"type":22},[58],"The goal of this is parallel arm, randomized clinical trial is to learn and understand the effect of daily smooth peanut butter consumption on gut and metabolic health of children age 6-13. The main objectives are:\n\nPrimary Objective: To determine the prebiotic effect of daily smooth peanut butter consumption for eight weeks on gut health, including microbiome-metabolome arrays, gut epithelial\u002Fbarrier function, and gut transit time, in school-aged children.\n\nSecondary Objective(s)\n\n1. To determine the effect of daily smooth peanut butter consumption for eight weeks on metabolic and inflammatory health markers, and measures of sleep quality in school-aged children.\n2. To determine the potential mechanisms and feasibility of incorporating peanut butter into the diets of school-aged children as part of healthy, personalized nutrition.\n\nResearch Intervention(s): Researchers compare two groups to see if there really is an effect of daily smooth peanut butter intake on gut and metabolic health. The two groups are:\n\n1. The 1st condition (PB) includes a normal diet supplemented daily with personalized portion of smooth PB, sandwiched between two plain unsalted saltine crackers.\n2. The 2nd condition (CTL) includes a normal diet supplemented daily with an isocaloric amount of a nut-free, vegetable oil-based chocolate spread, sandwiched between two plain unsalted saltine crackers.",[31],[243,87,126,244,245,246,247,124,248,89],"microbiome","peanut butter","metabolic health","dysbiosis","metagenomic","prebiotic",{"date":224,"type":37},{"date":251,"type":37},"2025-02-09",{"date":253,"type":22},"2027-05",{"name":108,"class":44},{"id":256,"slug":257,"hasResults":11,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":56,"phases":265,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":279,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":109},"100561288","effect-of-watermelon-on-gut-and-cardiometabolic-health-100561288","NCT06588218","Effect of Watermelon on Gut and Cardiometabolic Health","Effect of Daily Fresh Watermelon Consumption on Gut and Cardiometabolic Health in Young Adults With Overweight and Obesity","Inclusion Criteria:\n\n* Between 18 and 30 years old\n* Ability to speak and read in English\n* Overweight or Obese Class 1 and 2 (BMI ≥ 25 - 39.9 kg\u002Fm2)\n\nExclusion Criteria:\n\n* Intake of antibiotics in the last 3 months\n* Intake of pre\u002Fpro\u002Fpostbiotics in the last 3 months\n* Current or past (within the last 6 months) user of tobacco, marijuana, or E-cigarette products\n* Cardiovascular disease (will not exclude for hypertension), gastrointestinal disease (ulcerative colitis, celiac, Crohn's disease, diverticulosis, peptic ulcers, small intestinal bacterial overgrowth, short bowel syndrome), neurological (multiple sclerosis, meningitis, recent stroke) or endocrine disorders (uncontrolled thyroid disorders, growth hormone disorders, adrenal gland disorders, uncontrolled diabetes - A1C greater than 9%).\n* Food allergy to study foods\n* Any allergy to melon\n* Any allergy to the isocaloric snack (gluten)\n* Regular consumption of watermelon greater than 2 servings \u002F week\n* Current heavy alcohol use (≥ 15 drinks \u002F week for men, ≥ 8 drinks \u002F week for women\n* Class 3 Obesity (BMI \\> 40 kg\u002Fm2)\n* Current user of Citrulline, Arginine, Nitric Oxide or other supplements known to affect nitric oxide synthesis (beet root juice or any beet supplement, Pycnogenol \u002F Pine bark extract)\n* Known to be currently pregnant (self-disclosed)","30 Years",{"count":264,"type":22},36,[58],"The goal of this clinical trial is to evaluate the effect of daily fresh watermelon consumption for 6-weeks on gut health, including microbiome diversity, gut barrier and immune function in young adults with overweight and obesity. The main questions it aims to answer are:\n\n1. Will consuming fresh watermelon daily for 6-weeks will improve intestinal barrier health and increase microbiome diversity such as an increased population of beneficial 'probiotic' bacteria when compared to control participants consuming a low-fat snack?\n2. Will consuming fresh watermelon daily for six-weeks will improve other health measures, including body-composition, blood pressure, blood vessel function, blood lipid profiles, and measures of inflammation, as compared to control participants consuming a low-fat snack for the same time period?",[268,31],"Obesity and Overweight",[270,31,271,272,273,274,275,276,277,278],"Gut Microbiome","Diet","Overweight","Obesity","Watermelon","Lycopene","Citrulline","Metagenomic","vascular",{"date":224,"type":37},{"date":281,"type":37},"2024-10-13",{"date":283,"type":22},"2026-12",{"name":108,"class":44},{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":293,"maxAge":294,"enrollmentInfo":295,"targetDuration":4,"studyType":56,"phases":297,"briefSummary":298,"conditions":299,"keywords":304,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":109},"100604366","bioamicus-complete-for-functional-gastrointestinal-symptoms-in-infants-aged-0-to-24-months-100604366","NCT07148583","BioAmicus Complete for Functional Gastrointestinal Symptoms in Infants Aged 0 to 24 Months","Evaluation of the Efficacy and Safety of the Multistrain Probiotic \"BioAmicus Complete\" in Improving Gastrointestinal Symptoms in Children Aged 0-24 Months: A Randomized, Open-Label, Parallel-Group, Controlled Trial","CTBE2503","Inclusion Criteria:\n\n* Age 0-24 months at enrollment.\n* Infant has clinician-assessed functional gastrointestinal symptoms (e.g., colic\u002Firritability, regurgitation, constipation, loose stools), judged suitable for study participation.\n* Parent or legal guardian provides written informed consent and agrees to comply with study procedures (questionnaires\u002Fdiaries and sample collection, if applicable).\n* Caregivers agree to avoid other probiotic products during the study period, except as directed by the study team.\n\nExclusion Criteria:\n\n* Major congenital gastrointestinal anomalies or known chronic gastrointestinal diseases requiring ongoing prescription therapy (e.g., Hirschsprung disease, inflammatory bowel disease, short-bowel syndrome).\n* Clinically unstable condition or severe\u002Fcritical illness that could interfere with participation or safety in the opinion of the investigator.\n* Known or suspected primary or secondary immunodeficiency, or current immunosuppressive therapy.\n* History of severe allergy or hypersensitivity to components of the investigational product.\n* Recent use of systemic antibiotics within 14 days prior to baseline, or use of probiotic supplements within 14 days prior to baseline (per protocol).\n* Participation in another interventional clinical trial within 30 days prior to enrollment or during the study.\n* Any condition that, in the investigator's judgment, would make the participant unsuitable for the study or confound outcome assessments.","0 Days","24 Months",{"count":296,"type":22},110,[58],"Infants often experience functional gastrointestinal symptoms (e.g., colic, excessive gas, regurgitation, constipation, or loose stools) that distress families and may reflect an imbalance of the gut microbiome. This study evaluates whether the multistrain probiotic BioAmicus Complete can improve caregiver-reported gastrointestinal symptoms in infants 0-24 months and is safe for use in this population.\n\nThe primary assessment is the change in the Infant Gastrointestinal Symptom Questionnaire (IGSQ) total score from the start to the end of the study period. Secondary assessments include symptom domains (colic\u002Fregurgitation, stool frequency and consistency), caregiver quality of life, growth parameters (weight and length), health care utilization and antibiotic exposure, and overall safety\u002Ftolerability (adverse events and serious adverse events). Stool samples will be analyzed to explore changes in the gut microbiome.",[300,301,302,303,31],"Infantile Colic","Gastroesophageal Reflux (GER)","Functional Constipation","Functional Diarrhea",[305,306,307,308,309,310,123,311],"BioAmicus Complete","probiotic","multistrain probiotic","infant","functional gastrointestinal symptoms","Infant Gastrointestinal Symptom Questionnaire","stool microbiome","2026-01-28",{"date":314,"type":37},"2026-01-29",{"date":316,"type":37},"2025-09-05",{"date":318,"type":22},"2026-05-30",{"name":320,"class":44},"Haiphong University of Medicine and Pharmacy",{"id":322,"slug":323,"hasResults":11,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":11,"sex":202,"minAge":18,"maxAge":4,"enrollmentInfo":329,"targetDuration":331,"studyType":23,"phases":4,"briefSummary":332,"conditions":333,"keywords":343,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":363},"100612907","gut-microbiome-in-gynecological-cancer-patients-with-pelvic-toxicity-controls-versus-ozone-treatment-microzoginetox-100612907","NCT07259681","Gut Microbiome in Gynecological Cancer Patients With Pelvic Toxicity: Controls Versus Ozone Treatment. (MicrOzoGineTox)","Intestinal Microbiome Profiles in Women With Gynecological Tumors and Pelvic Toxicity Secondary to Radiotherapy and Chemotherapy: Comparison With Controls and Effect of Rectal Ozone Treatment.","MicrOGineTox","Inclusion Criteria for all patients (Cases and Controls):\n\n1. Adult women (\\>=18 years).\n2. Diagnosed with gynecological tumors (any location and stage).\n3. Previously treated with radiotherapy and\u002For chemotherapy.\n4. Must accept and sign the specific informed consent for this study.\n\n   Additional Inclusion Criteria for inclusion in the TPIRQT Group (Cases):\n5. Must present chronic TPIRQT with \\>= 3 months of duration after habitual symptomatic treatment.\n6. Must have a toxicity Grade of 2 (moderate symptoms, limiting instrumental ADL) or higher, according to the CTCAE v.5.0 scale.\n\nExclusion Criteria for all patients (Cases and Controls):\n\n1. Not meeting all inclusion criteria.\n2. Presence of active inflammatory bowel disease (e.g., Crohn's Disease, Ulcerative Colitis) or a history of major gastrointestinal resection (excluding appendectomy) that could significantly alter gut anatomy and microbiota.\n3. Any uncontrolled intercurrent illness or psychiatric condition that, in the investigator's opinion, would limit compliance with study requirements or interfere with the interpretation of results.\n4. Unwillingness or inability to provide written informed consent for study participation.",{"count":330,"type":22},38,"4 Months","Patients treated for gynecological tumors with radiotherapy (RT) and\u002For chemotherapy (CT) frequently develop pelvic toxicity (TPIRQT), a condition that can become persistent, progressive, and refractory to standard treatments. This toxicity, affecting the rectum (proctitis), bladder (cystitis), and vagina (mucositis), severely deteriorates quality of life. Standard options for refractory cases are limited; at our center, rectal ozone therapy is used with high rates of symptomatic improvement (66-75%). Emerging evidence suggests a link between gut microbiota and the development of TPIRQT. However, it is unknown how rectal ozone therapy may influence the gut microbiome or if this modulation is part of its therapeutic mechanism. This prospective observational study will investigate the potential relationship between gut microbiome profiles (composition and diversity), the presence and severity of TPIRQT, and the response to rectal ozone therapy.",[334,335,336,337,338,339,340,341,342,31],"Pelvic Toxicity","Radiation Toxicity","Chemotherapy Toxicity","Gynecological Tumors","Radiation Proctitis","Radiation Cystitis","Vaginal Mucositis","Vulvar Mucositis","Quality of Life",[344,345,346,347,348,349,350,351,352,353,31],"Gut microbiota","Ozone","Ozone therapy","Gynecological tumors","Radiotherapy","Chemotherapy","Side effects","Actinic proctitis","Actinic cystitis","Quality of life","2025-12-16",{"date":356,"type":37},"2025-12-22",{"date":358,"type":22},"2026-01-15",{"date":360,"type":22},"2028-03-31",{"name":362,"class":44},"Bernardino Clavo, MD, PhD",2,{"id":365,"slug":366,"hasResults":11,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":374,"conditions":375,"keywords":378,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":109},"100487853","alteration-of-symbiosis-intestinal-microbiota-on-patients-with-anorexia-nervosa-100487853","NCT05632497","Alteration of Symbiosis Intestinal Microbiota on Patients With Anorexia Nervosa","Study of Translational Process of Relationship Between Intestinal Microbiota of Dysbiosis and the Psychic Symptoms of Anorexia Nervosa (Eating Disorders and Anxio-depression Disorders)","INT-METAVOSA","Inclusion Criteria:\n\nFor patients:\n\n* Patients aged ≥18 years;\n* Anorexia according to DSM-5 and CIDI (Composite International Diagnostic Interview);\n* Body mass index (BMI) (P\u002FT2) \\\u003C 15;\n* Hospitalization for nutrition rehabilitation;\n* Covered by a health insurance;\n* Informed consent form signed.\n\nFor Healthy Volunteers:\n\n* Aged ≥18 years;\n* 18.5 \\\u003C BMI (P\u002FT2) \\\u003C 25;\n* Covered by a health insurance;\n* Informed consent form signed.\n\nExclusion Criteria:\n\nFor patients:\n\n* Patients no-responding all criteria of DSM-5 or CIDI scores;\n* Taken of antibiotic treatment 2 months \u002F or laxativ 3 weeks before hospitalization;\n* Somatic comorbidity should perturb intestinal microbiota (Crohn's disease, diabetes and all other chronic inflammatory diseases);\n* Patients under guardianship;\n* Patients covered by french AME scheme.\n\nFor Healthy Volunteers:\n\n* Any disease should perturb intestinal microbiota;\n* Recent ponderal variation;\n* Taken of antibiotic treatment 2 months or laxativ 3 weeks before hospitalization;\n* Under guardianship;\n* Covered by french AME scheme.",{"count":373,"type":22},120,"The purpose of this study will be to study the association between the level of psychic symptomatic of anorexia nervosa (AN) (intensity of food restriction, symptoms of anxiety and depression) and alteration of host environment symbiosis and the mechanism (dysbiosis of intestinal microbiota, increase of intestinal permeability, immunity alteration and low-grade inflammation).",[376,31,377],"Anorexia Nervosa","Anxious Depression",[379,31,380,381,382],"Anorexia nervosa","Anxious depression","Intestinal microbiota","Body mass index","2025-11-19",{"date":385,"type":37},"2025-11-24",{"date":387,"type":37},"2024-05-23",{"date":389,"type":22},"2026-10",{"name":391,"class":44},"Assistance Publique - Hôpitaux de Paris",{"id":393,"slug":394,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":400,"targetDuration":4,"studyType":56,"phases":402,"briefSummary":404,"conditions":405,"keywords":418,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":109},"100608614","phase-4-modulation-of-gut-microflora-with-rifaximin-to-reduce-high-platelet-reactivity-in-post-acs-patients-on-ticagrelor-100608614","NCT07203846","Modulation of Gut MicroFLORA With Rifaximin to Reduce High Platelet Reactivity in Post-ACS Patients on Ticagrelor","Modulation of Gut Microflora With Rifaximin to Reduce High Platelet Reactivity in Post-Acute Coronary Syndrome Patients on Ticagrelor (FLORA-ACS)","FLORA-ACS","Inclusion criteria:\n\n* Between 18 and 80 years of age\n* History of acute coronary syndrome no sooner than 1 month and no later than 12 months prior to study inclusion\n* Current treatment with ticagrelor (90 mg orally twice a day)\n* High platelet reactivity assessed with multiple electrode aggregometry method (AUC of \\>46 U)\n* Provision of informed consent prior to any study procedures\n\nExclusion criteria:\n\n* History of hypersensitivity to rifaximin or other rifamycin-derived agent\n* Ongoing treatment with rifamycins\n* Platelet count \\\u003C 100×10\\^9\u002FL or \\> 450×10\\^9\u002FL\n* Treatment with antibiotics, probiotics, or glucocorticoids within 3 months prior to study inclusion\n* History of gastrointestinal diseases such as inflammatory bowel disease, bowel obstruction, or gastrointestinal tumor\n* Infection, including gastrointestinal infection, within a month prior to study inclusion\n* History of Clostridium difficile infection\n* Current use of specific medications (warfarin, glycoprotein IIb\u002FIIIa inhibitors, immunosuppressants, bile acid sequestrants, antidiarrheal agents)\n* Impaired liver function classified as Child-Pugh class B or C\n* Hemodynamic instability\n* Pregnancy or breastfeeding\n* Patients considered by the investigator to be uncooperative",{"count":401,"type":22},50,[403],"PHASE4","The FLORA-ACS study aims to evaluate the relationship between dysbiosis and high platelet reactivity during treatment with ticagrelor in patients with a history of acute coronary syndromes and investigate the use of rifaximin to eliminate dysbiosis and thus provide effective antiplatelet treatment.",[406,407,408,409,410,411,412,413,414,415,31,416,417],"ACS - Acute Coronary Syndrome","Ticagrelor","Microbiota","Platelet Aggregation","Myocardial Infarction (MI)","Blood Platelets","Drug Effects","Platelet Aggregation Inhibitors","Drug Resistance","Platelet Function Tests","Anti-Bacterial Agents","Rifaximin",[419,420,421,422,423,243,424,425,426,427],"high platelet reactivity","HPR","Multiplate aggregometry","multiple electrode aggregometry","MEA","gut flora","eubiotic","16S rRNA sequencing","P2Y12 inhibitor","2025-09-25",{"date":430,"type":37},"2025-10-02",{"date":432,"type":22},"2026-01-01",{"date":434,"type":22},"2027-06-30",{"name":436,"class":44},"Collegium Medicum w Bydgoszczy",{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":445,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":447,"conditions":448,"keywords":449,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":109},"100607639","impact-of-dysbiosis-inducing-drugs-on-effectivity-of-immune-checkpoint-inhibitor-in-non-small-cell-lung-cancer-patients-100607639","NCT07191171","Impact of Dysbiosis-inducing Drugs on Effectivity of Immune Checkpoint Inhibitor in Non-small Cell Lung Cancer Patients","Impact of Dysbiosis-inducing Drugs on Effectivity of Immune Checkpoint Inhibitor in Non-small Cell Lung Cancer Patients: a Retrospective Study","ICI","Inclusion Criteria:\n\n* Adult (≥18 years)\n* Confirmed diagnosis of NSCLC\n* Stage IV or stage III-C NSCLC\n* Immunotherapy treatment\n\nExclusion Criteria:\n\n* Refusal to reuse data for scientific research purposes\n* Minor patient\n* Disease stage below stage III-C\n* Patient included in a clinical trial with an unknown randomization arm (double-blind study)\n* Lack of relevant data on concomitant treatments, biology, or clinical outcomes",{"count":446,"type":22},800,"Lung cancer is the leading cancer in France in terms of mortality. The prognosis of the disease is closely correlated with the diagnostic stage and the majority of patients are diagnosed at a metastatic stage. The arrival of immunotherapy has made it possible to change the therapeutic paradigm by significantly improving the survival of metastatic patients. Despite this progress, only 20 to 30% of patients respond to immunotherapy. The search for predictive factors of response to or resistance to these drugs is of major importance for better patient selection. Among these factors, the intestinal microbiota appears to be closely correlated with the response to immunotherapy via the education of adaptive anticancer immunity. Thus, several bacterial species have been associated with patient survival or disease progression. Interestingly, the abundance of these same bacteria can be modulated by certain drugs co-prescribed with immunotherapy. These dysbiotic treatments or those leading to a significant modification of the composition of the intestinal microbiota could then modulate the response to immunotherapy and therefore patient survival. The objective of this study is therefore to objectify the impact of several therapeutic classes modifying the intestinal microbiota initiated in the 90 days preceding D1 of immunotherapy on the survival of patients with locally advanced (stage III-C) or metastatic (stage IV) non-small cell lung cancer (NSCLC)",[31],[31,450,451,381,452],"Lung cancer","Non-small cell lung cancer","Immunotherapy","2025-09-22",{"date":455,"type":37},"2025-09-24",{"date":457,"type":37},"2025-02-05",{"date":459,"type":22},"2026-02-05",{"name":461,"class":44},"University Hospital, Strasbourg, France",{"id":463,"slug":464,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":469,"enrollmentInfo":470,"targetDuration":4,"studyType":56,"phases":472,"briefSummary":474,"conditions":475,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":109},"100461449","phase-2-microbiome-metabolites-and-alcohol-in-hiv-to-reduce-cvd-rct-100461449","NCT05288790","Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT","META HIV CVD","Inclusion Criteria:\n\n* HIV infected\n\nExclusion Criteria:\n\n* Not fluent in English","89 Years",{"count":471,"type":22},250,[473],"PHASE2","Among people living with HIV, heavy drinking increases the risk of heart disease and death. Studies suggest that alcohol changes the number and kind of bacteria in your gut and these changes increase the risk of heart disease and death. This randomized controlled trial will determine whether a pill containing healthy gut bacteria can increase the number good bacteria in the gut, lower levels of inflammation, and lower the risk of heart disease and death.",[476,31,477,478,479],"Microtia","Alcohol Drinking","HIV Infections","Cardiovascular Diseases","2025-06-18",{"date":482,"type":37},"2025-06-24",{"date":484,"type":37},"2023-09-18",{"date":486,"type":22},"2027-02-28",{"name":488,"class":44},"Vanderbilt University Medical Center",{"id":490,"slug":491,"hasResults":11,"nctId":492,"briefTitle":493,"officialTitle":494,"acronym":495,"eligibilityCriteria":496,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":56,"phases":499,"briefSummary":500,"conditions":501,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":109},"100578312","effects-of-endocrine-disruptors-on-the-gut-microbiota-and-assessment-of-their-impact-on-colorectal-cancer-development-permica-100578312","NCT06809660","Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development (PERMICA)","Effects of Endocrine Disruptors on the Gut Microbiota and Assessment of Their Impact on Colorectal Cancer Development","PERMICA","Inclusion Criteria:\n\n* Scheduled endoscopy during the inclusion visit or within 18 months following this consultation.\n* Signed consent from the patient after clear and fair information about the study is provided.\n* Patient is free of guardianship, curatorship, or dependency.\n* Patient is covered by a social security system or through a third party.\n\nExclusion Criteria:\n\n* Patients receiving treatment for chronic inflammatory bowel disease;\n* Patients with hereditary colorectal cancer;\n* Use of antibiotics, probiotics, or prebiotics within four weeks prior to stool sample collection;\n* Patients who have undergone neoadjuvant chemotherapy or radiotherapy;\n* Patients who have had previous surgical resection;\n* Patients under enhanced protection: minors, individuals deprived of liberty by judicial or administrative decision, individuals residing in healthcare or social institutions, and adults under legal protection;\n* Pregnant and\u002For breastfeeding women.\n\nExclusion Criteria During Study Participation:\n\n* Patients presenting any of the following during their participation in the study will be excluded:\n* Use of antibiotics, probiotics, or prebiotics before stool collection (between inclusion and stool collection, which may occur within the month);\n* Endoscopy not performed within 18 months following inclusion;\n* Failure to send\u002Freceive stool samples",{"count":498,"type":22},200,[58],"Colorectal cancer is the third most common cancer worldwide, yet it was the second leading cause of cancer-related deaths in 2020. The average French population faces a colorectal cancer risk partly linked to lifestyle factors. The majority of colorectal cancer cases (approximately 85%) are not caused by hereditary mutations. Environmental factors, such as lifestyle or diet (notably through endocrine disruptors), can affect the gut microbiota (a collection of microorganisms - bacteria, viruses, parasites, and fungi - residing in the intestinal environment) and lead to disturbances in its composition, referred to as dysbiosis. While the mechanisms underlying dysbiosis associated with colorectal cancer remain poorly understood, the involvement of certain ingested substances, known as xenobiotics, is increasingly suspected, including endocrine disruptors. Among the most common endocrine disruptors found in water and food are parabens and phthalates, which will be examined in detail in this study. These substances may be directly involved in the development of colorectal cancer and in response to its treatment.\n\nThe main objective of this studie is to characterize the relationship between colorectal cancer diagnosis, activity\u002Fcomposition of the gut microbiota, and patients' exposure to selected endocrine disruptors, particularly parabens and phthalates.",[502,503,408,31],"Colorectal Cancer (CRC)","Endocrine Disruptors","2025-02-12",{"date":506,"type":37},"2025-02-13",{"date":508,"type":37},"2025-01-21",{"date":510,"type":22},"2034-01-21",{"name":512,"class":44},"Poitiers University Hospital",{"id":514,"slug":515,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":520,"enrollmentInfo":521,"targetDuration":4,"studyType":56,"phases":522,"briefSummary":523,"conditions":524,"keywords":529,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":544},"100576953","phase-4-impact-of-probiotics-on-gut-microbiome-during-antibiotic-prophylaxis-in-elective-orthopedic-surgery-100576953","NCT06791993","Impact of Probiotics on Gut Microbiome During Antibiotic Prophylaxis in Elective Orthopedic Surgery","Impact of Probiotics Combined with Antibiotic Prophylaxis on Gut Microbiome Balance in Patients Undergoing Elective Orthopedic Surgery, Double-Blinded Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged between 18 and 65 years\n* Scheduled for elective low-risk orthopedic surgery (carpal tunnel release, A1 pulley release, knee arthroscopic surgery).\n\nExclusion Criteria:\n\n* History of infection or antibiotic use within the last 12 weeks.\n* Use of routine probiotics, vitamins, or herbal supplements in the last 4 weeks.\n* Known allergy to beta-lactam or cephalosporin antibiotics.\n* History of autoimmune disease, uncontrolled systemic disease, or chronic inflammatory conditions (e.g., systemic lupus erythematosus, rheumatoid arthritis).\n* History of chronic intestinal diseases such as small intestine bacterial overgrowth (SIBO), irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or celiac disease.\n* Increased risk of infection due to medical comorbidities or use of immunosuppressive drugs.","65 Years",{"count":55,"type":22},[403],"This study aims to evaluate whether probiotics can help maintain a healthy gut microbiome in patients receiving prophylactic antibiotics during elective orthopedic surgery. Antibiotics, while effective in preventing infections, can disrupt the balance of gut bacteria, leading to dysbiosis. The study hypothesizes that the use of probiotics during the perioperative period can prevent or reduce this disruption, supporting gut health and overall well-being. The research seeks to answer whether combining probiotics with routine antibiotic prophylaxis can preserve gut microbiome balance and improve patient outcomes.",[31,525,526,527,528],"Gut -microbiota","Microbiome Analysis","Probiotic","Antibiotic Prophylaxis",[270,530,531,151,528,532,533,534],"Intestinal Dysbiosis","Surgical Site Infection","Human Milk Oligosaccharides (HMO)","Shotgun Metagenomic Sequencing","Short-Chain Fatty Acids (SCFAs)","2025-01-18",{"date":537,"type":37},"2025-01-24",{"date":539,"type":22},"2025-02-01",{"date":541,"type":22},"2025-10-01",{"name":543,"class":44},"Acibadem Maslak Hospital",6,{"id":546,"slug":547,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":17,"minAge":552,"maxAge":553,"enrollmentInfo":554,"targetDuration":4,"studyType":56,"phases":556,"briefSummary":557,"conditions":558,"keywords":560,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":109},"100454050","respiratory-dysbiosis-in-preschool-children-with-asthma-predictive-of-a-severe-form-100454050","NCT05192499","Respiratory Dysbiosis in Preschool Children with Asthma: Predictive of a Severe Form","DREAM","Inclusion Criteria:\n\n* Age greater than 1 year and less than 3 years\n* Diagnosis of asthma by a pediatrician\n* Parental consent\n* Affiliation to the social security system\n\nExclusion Criteria:\n\n* Chronic pathologies: congenital heart disease, immune deficiency, cystic fibrosis, bronchopulmonary dysplasia, encephalopathy, primary ciliary dyskinesia, laryngomalacia, digestive pathology requiring digestive surgery\n* Premature \\\u003C 34 SA\n* Recent antibiotic therapy (\\\u003C 7 days)\n* Treatment with oral corticosteroid therapy within the previous 10 days.\n* Patient whose parent(s) is (are) minor(s)","1 Year","3 Years",{"count":555,"type":22},30,[58],"The prevalence of asthma in preschool children is between 11 and12%. Inhaled corticosteroid therapy is the main therapy used, however this treatment seems insufficiently effective in some children.\n\nRecent research in cystic fibrosis has made it possible to highlight pulmotypes corresponding to the different stages of pulmonary dysbiosis, and a predictive microbiological signature of an increased risk of early primocolonization to P. aeruginosa. These pulmotypes are the result of the so-called \"enterotyping\" analysis, a biostatistical method that makes it possible to stratify individuals according to the analysis of the microbiota. In the light of these data, it seems interesting to transcribe the concept of using a biomarker of the microbiota in the monitoring of a chronic lung disease such as asthma.\n\nThe hypothesis is that there is respiratory dysbiosis causing corticosteroid resistance to treatment in children under 3 years of age with severe asthma.",[559,31],"Asthma in Children",[561,562,563],"Paediatric Pulmonology","asthma","respiratory microbiome","2024-09-19",{"date":566,"type":37},"2024-09-23",{"date":568,"type":37},"2022-02-04",{"date":570,"type":22},"2028-02-04",{"name":572,"class":44},"University Hospital, Brest",{"id":574,"slug":575,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":581,"enrollmentInfo":582,"targetDuration":4,"studyType":56,"phases":583,"briefSummary":584,"conditions":585,"keywords":588,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":592,"lastUpdatePostDateStruct":593,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":109},"100516498","alcohol-misuse-gut-microbial-dysbiosis-and-prep-care-continuum-application-and-efficacy-of-sbirt-intervention-100516498","NCT06005298","Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention","Alcohol Misuse, Gut Microbial Dysbiosis and PrEP Care Continuum: Application and Efficacy of SBIRT Intervention (SEAL)","SEAL","Inclusion Criteria:\n\n* Age: 18-85 years\n* Confirmation of seronegative HIV, Hep B, and Hep C status\n* PrEP users\n* English-speaking or Spanish speaking\n* Cognitively competent to provide consent\n* Attend a participating healthcare facility\n\nExclusion Criteria:\n\n* Inability to consent\n* Existing diagnosis of major psychiatric illness\n* Unstable medical conditions (e.g., cancer)\n* Taking immunosuppressants or Chemotherapy\n* Taking daily antibiotics or probiotics\n* Severe gastrointestinal\u002Fliver disease\n* Autoimmune disease","85 Years",{"count":373,"type":22},[58],"This randomized control trial study among Pre-exposure prophylactic users (PrEP) aims to learn and determine the efficacy of Screening, brief intervention, and referral to treatment (SBRIT) in reducing the risk of alcohol use. The main questions it aims to answer are:\n\n1. How alcohol use impacts the PrEP continuum and to understand how early intervention and treatment approach affects alcohol use and PrEP adherence.\n2. Investigate the effectiveness of the SBIRT intervention in preventing hazardous alcohol use and its impact on gut dysbiosis in PrEP users.\n3. To determine alterations in the gut microbiome (dysbiosis), intestinal homeostasis, systemic inflammation, and markers of liver disease associated with hazardous alcohol use among PrEP users.",[586,587,31,478],"Alcohol Use Disorder","Risk Behavior, Health",[589,590,591],"PrEP","Alcohol","SBIRT","2024-07-17",{"date":594,"type":37},"2024-07-22",{"date":596,"type":37},"2023-08-01",{"date":598,"type":22},"2027-10-24",{"name":600,"class":44},"Shirish S Barve",{"id":602,"slug":603,"hasResults":11,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":11,"sex":202,"minAge":18,"maxAge":609,"enrollmentInfo":610,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":612,"conditions":613,"keywords":617,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":623,"lastUpdatePostDateStruct":624,"startDateStruct":626,"completionDateStruct":628,"leadSponsor":630,"locationsCount":109},"100501740","prenatal-antibiotics-and-breast-milk--neonatal-iga-100501740","NCT05813184","Prenatal Antibiotics and Breast Milk \u002F Neonatal IgA","Effect of Prenatal Antibiotics on Breast Milk Immune Function and on the Development of Neonatal Intestinal Immune System: the Role of IgA","PAIGAN 1","Inclusion Criteria:\n\n* expression of written informed consent\n* an antibiotic treatment (any molecule) for at least 7 days consecutively after the 32 weeks of pregnancy (or the absence of exposure to any systemic antibiotic treatment during pregnancy for the control group)\n* the intention to breastfeed their neonates as long as possible during the first year of life\n\nExclusion Criteria:\n\n* absence of written informed consent\n* the intention to formula feed exclusively (or the presence of significant maternal concerns about breastfeeding)\n* a maternal antibiotic treatment shorter than 7 days\n* the presence of pre-existing maternal immune-mediated disorders (including immunodeficiencies and chronic infectious diseases)\n* a delivery at a gestational age \\\u003C 34 weeks\n* the administration of antibiotics to neonates after birth, within the first week of life.","40 Years",{"count":611,"type":22},82,"In this biological study, the investigators will evaluate the levels of breast milk IgA, neonatal fecal IgA, and the composition of breast milk and fecal microbiota throughout the first 12 months of life in neonates born to mothers treated or not treated with prenatal antibiotics for at least 7 days after the 32nd weeks of gestation",[614,528,31,615,616],"Prenatal Exposure Delayed Effects","Neonatal Infection","Breast Milk; Noxious Influence, Affecting Fetus",[618,619,620,621,622],"IgA","Prenatal antibiotics","breast milk","feces","neonatal immune system","2024-06-24",{"date":625,"type":37},"2024-06-26",{"date":627,"type":37},"2023-10-08",{"date":629,"type":22},"2025-10-30",{"name":631,"class":44},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"id":633,"slug":634,"hasResults":11,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":638,"eligibilityCriteria":639,"healthyVolunteers":16,"sex":17,"minAge":640,"maxAge":4,"enrollmentInfo":641,"targetDuration":4,"studyType":56,"phases":643,"briefSummary":644,"conditions":645,"keywords":653,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":363},"100551493","axsend-exploring-immune-and-microbiota-effects-of-a-partial-enteral-nutrition-diet-in-axial-spondyloarthritis-100551493","NCT06460805","axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in Axial Spondyloarthritis","axSEND: Exploring Immune and Microbiota Effects of a Partial Enteral Nutrition Diet in People With Axial Spondyloarthritis","axSEND","Eligibility Criteria for Participants with axSpA\n\nInclusion criteria. Participants will fulfil ALL of the following:\n\n* Diagnosis of axSpA (fulfilling the ASAS criteria)\n* Active disease (BASDAI score ≥4) on day of study visit\n* Stable on treatment \\[defined as (1) no major change to therapy (change in treatment type) in the preceding 3 months AND (2) no minor change in therapy (adjustment of treatment dosage) in the preceding 1 month\\]\n* Age ≥ 16 years\n* Willing and able to give informed written consent.\n\nExclusion. Participants will have NONE of the following:\n\n* Pregnancy or breastfeeding\n* Prior diagnosis of IBD\n* Recipient of chemotherapy\u002Fimmunotherapy\u002Fradiotherapy in prior 3 months\n* Recent systemic antibiotic use (within last 1 month)\n* Current eating disorder\n* Food allergy incompatible with diet (e.g. cow's milk allergy)\n* Following a vegan diet\n* Major surgery in prior 3 months or planned in forthcoming 3 months.\n* Unable or unwilling to give informed consent\n* Unable or unwilling to try the PEN diet.\n\nEligibility Criteria for Healthy Volunteer Participants\n\nInclusion criteria. Participants will fulfil ALL of the following:\n\n* Age ≥ 16 years\n* Current student and\u002For staff member at the University of Glasgow\n* Willing and able to give informed written consent\n\nExclusion. Participants will have NONE of the following:\n\n* Pregnancy or breastfeeding\n* Prior diagnosis of an immune-mediated inflammatory condition\n* Recipient of chemotherapy\u002Fimmunotherapy\u002Fradiotherapy in prior 3 months\n* Recent systemic antibiotic use (within last 1 month)\n* Current eating disorder\n* Food allergy incompatible with diet (e.g. cow's milk allergy)\n* Following a vegan diet\n* Major surgery in prior 3 months or planned in forthcoming 3 months.\n* Unable or unwilling to give informed consent\n* Unable or unwilling to try the PEN diet.","16 Years",{"count":642,"type":22},62,[58],"People with axial spondyloarthritis (axSpA) often have intestinal inflammation and intestinal microbiome dysbiosis, with some similarities to Crohn's-like inflammatory bowel disease (IBD) gut inflammation. However, research has not addressed whether Partial Enteral Nutrition (PEN), a diet formed of a liquid formula and some solid whole foods, which is effective at inducing remission in IBD, may influence the dysbiotic microbiome and inflamed, hyperpermeable intestine of axSpA patients, and whether these changes may be accompanied by alterations in systemic markers of inflammation. Thus, there is a need to determine the effects of PEN on these aspects in axSpA patients.\n\nIn this study, the investigators intend to trial a 2-week course (with optional additional 2-week extension) of a PEN diet in people with active axSpA disease. A group of healthy volunteers following the same diet will act as a control.",[646,647,180,31,648,649,650,651,652],"Axial Spondyloarthritis","Ankylosing Spondylitis","Arthritis","Spondylitis","Spondylarthritis","SpA","AxSpA",[654,655,656,657,658,271,659,660],"Partial Enteral Nutrition","Nutrition","Axial spondyloarthritis","Ankylosing spondylitis","axSpA","PEN","AS","2024-06-13",{"date":663,"type":37},"2024-06-14",{"date":665,"type":37},"2024-04-25",{"date":667,"type":22},"2025-08-01",{"name":669,"class":44},"NHS Greater Glasgow and Clyde",{"id":671,"slug":672,"hasResults":11,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":520,"enrollmentInfo":678,"targetDuration":4,"studyType":56,"phases":680,"briefSummary":681,"conditions":682,"keywords":687,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":691,"lastUpdatePostDateStruct":692,"startDateStruct":694,"completionDateStruct":696,"leadSponsor":698,"locationsCount":109},"100550785","phase-2-fecal-microbiota-transplantation-in-axial-spondyloarthritis-100550785","NCT06451588","Fecal Microbiota Transplantation in Axial Spondyloarthritis","Donor Versus Autologous Fecal Microbiota Transplantation for Axial Spondyloarthritis: a Double Blind, Placebo-Controlled, Randomized Trial","MicroSpA","Inclusion Criteria:\n\n* Axial Spondyloarthritis according to the ASAS classification criteria\n* Active disease defined as ASDAS ≥2.1 with elevated CRP ≥4 OR active inflammation on MRI within the last 3 months\n* Onset of axial SpA within last 10 years\n* Unsatisfactory relief of NSAIDs\n* On stable immunomodulatory treatment (TNFi, IL17i or JAKi) the last 3 months\n\nExclusion Criteria:\n\n* Planned dose adjustment or change in immunomodulatory treatment the next 90 days\n* Disease or disorder with life expectancy of ≤5 years\n* Severe immune deficiency (acquired, congenital og du to medication)\n* Previous treatment with FMT\n* Regular use of opioids with the exception of codeine and tramadol\n* Any specific diagnosis that could explain or contribute to the patients back pain (e.g. tumor, fracture, infection or degenerative disease)\n* Inflammatory spinal disease other than axSpA\n* Severe psychiatric disorder, alcohol- or drug abuse\n* Active inflammatory bowel disease\n* Microscopic colitis, diverticulitis or ileus\n* Active psoriasis\n* Fibromyalgia\n* Abdominal surgery excluding appendectomy, cholecystectomy, hysterectomy, caesarian section, sapling-ooforectomy and hernia surgery\n* Malignant disease excluding basalioma and melanoma stage 1\n* Conditions with expected necessary treatment with antibiotics during the study period, e.g. periodontitis end ischemic digital ulcers\n* Treatment with antibiotics 12 weeks prior to study entry\n* Pregnancy, lactation or planned pregnancy within the next 3 months\n* Contraindications for rectal catheter insertion\n* Planned rehabilitation program the next 90 days\n* Limited ability to comply with protocol requirements, including biobank participation",{"count":679,"type":22},99,[473],"Although biologic therapy have revolutionized the treatment of Spondyloarthrtitis (SpA), many patients do not experience complete relief of SpA related complaints.\n\nIt has been established that patients with SpA have an altered composition of microorganisms (microbiota) in the gut compared to healthy controls, and that this correlates to disease activity and respons to therapy.\n\nThe goal of this randomized double-blind study is to evaluate the efficacy of fecal microbiota transplantation (FMT) in patients with axial SpA with a suboptimal effect of biologic therapy.\n\nThe main questions it aims to answer are:\n\n* Can FMT reduce disease activity in axial SpA?\n* Can FMT alleviate pain and reduce fatigue in axial SpA?\n* Is the composition of microorganisms restored to normal in patients with SpA after a treatment with FMT?\n\nParticipants will receive a single treatment in the form of an enema with either donor FMT or placebo at baseline. The primary endpoint will be evaluated after 90 days, but efficacy and safety will be monitored from baseline until 365 days.",[646,647,31,683,649,648,684,685,686],"Spondyloarthritis","Musculoskeletal Diseases","Spinal Disease","Joint Diseases",[646,688,62,408,689,690],"Microbiome","FMT","RCT","2024-06-04",{"date":693,"type":37},"2024-06-11",{"date":695,"type":37},"2024-06-01",{"date":697,"type":22},"2026-03",{"name":699,"class":44},"University Hospital of North Norway",{"id":701,"slug":702,"hasResults":11,"nctId":703,"briefTitle":704,"officialTitle":705,"acronym":706,"eligibilityCriteria":707,"healthyVolunteers":16,"sex":17,"minAge":262,"maxAge":708,"enrollmentInfo":709,"targetDuration":4,"studyType":56,"phases":711,"briefSummary":712,"conditions":713,"keywords":718,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":722,"lastUpdatePostDateStruct":723,"startDateStruct":725,"completionDateStruct":727,"leadSponsor":728,"locationsCount":109},"100544862","the-mind-gut-digital-pilot-intervention-study-100544862","NCT06374407","The MIND-GUT Digital Pilot Intervention Study","Exploring the Interplay Between Diet, Obesity, Mental Health, and the Gut Microbiome. The MIND-GUT Digital Pilot Intervention Study.","MINDGUT","Inclusion Criteria:\n\n* age 30- 50;\n* BMI ≥ 30 kg\u002Fm2;\n* stable physical activity;\n* one person per household;\n* commitment to full protocol.\n\nExclusion Criteria:\n\n* use of psychiatric medications (e.g., serotonin reuptake inhibitors);\n* use of weight loss medications (GLP-1 receptor agonists);\n* food allergies affecting adherence to the MIND diet;\n* diagnosis of eating disorders;\n* diagnosis of diabetes;\n* diagnosis of polycystic ovary syndrome;\n* sensory deficits (e.g., COVID-19-induced loss of taste\u002Fsmell);\n* antibiotic use during the latest 3 months;\n* participation in another study;\n* language understanding limitations (i.e., not able to understand either Swedish or English); - coeliac\u002Finflammatory bowel disease;\n* planned weight management program within three months;\n* pregnancy;\n* lactation;\n* menopause.","50 Years",{"count":710,"type":22},126,[58],"This 12-week pilot study aims to evaluate the feasibility and effectiveness of a dietary intervention targeting diet, obesity, mental health, and the gut microbiome in promoting weight loss and enhancing mental health among obese men and women aged 30-50. Participants, excluding those with specific medical conditions, will be randomly assigned to either an intervention or control group using a meal planning smartphone app. Clinical assessments will include anthropometry, mental health questionnaires, dietary recalls, and stool sample collections. The study's endpoints include program retention, adherence, changes in body weight, mental health, and gut microbiome diversity. Statistical analyses will evaluate intervention effects and the potential mediating roles of the gut microbiome. This pilot study has implications for health policies, public healthcare, digital health companies, and the biotech and pharmacology industries. Future plans involve a large-scale intervention study in multiple countries with ongoing collaborations.",[273,714,715,716,717,31],"Depressive Symptoms","Anxiety","Stress","Eating Habit",[719,720,721,123],"mental health","obesity","mind gut diet","2024-04-15",{"date":724,"type":37},"2024-04-18",{"date":726,"type":22},"2024-06",{"date":283,"type":22},{"name":729,"class":44},"University of Skövde"]