[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gut-microbiota\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gut-microbiota":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,42,74,100,142,169,200,237,263,287,332,366,392,420,442,471,497,530,553,577,609,637,660,689,711],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100645313","analysis-of-the-role-of-the-microbiota-in-diverticular-disease-100645313",false,"NCT07681505","Analysis of the Role of the Microbiota in Diverticular Disease","Analysis of the Role of the Microbiota in Diverticular Disease.","Inclusion Criteria:\n\n* Age 18 or older.\n* Signing of the informed consent form.\n* Assignment to one of the study groups mentioned above.\n\nExclusion Criteria:\n\n* An episode of acute diverticulitis located in the right colon or transverse colon.\n* Antibiotic treatment within the six weeks prior to the episode (except for antibiotics started in the emergency department or within 24 hours prior to sample collection).\n* Mechanical bowel preparation within the three weeks prior to sample collection.\n* Diagnosis of colorectal cancer.\n* Diagnosis of inflammatory bowel disease.\n* Failure to sign the informed consent form.","ALL","18 Years",{"count":20,"type":21},285,"ESTIMATED","24 Months","OBSERVATIONAL","A single-center, prospective observational cohort study conducted at the University Hospital of Navarra. The primary objective is to expand knowledge of diverticular disease and its pathological variants, as well as the influence of the microbiota in our environment, both clinically and molecularly; to describe the clinical and pathological characteristics of patients with diverticulosis and acute diverticulitis; to analyze any differences in the microbiota; and to identify the risk factors and groups associated with diverticular disease in order to establish the best strategies for prevention and treatment.",[26,27,28],"Diverticular Disease of Colon","Acute Diverticulitis","Gut Microbiota","NOT_YET_RECRUITING","2026-06-26",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":21},"2027-06-01",{"date":37,"type":21},"2032-01-01",{"name":39,"class":40},"Hospital of Navarra","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":41},"100639450","developing-precision-microbiota-based-cocktail-modification-therapy-to-delay-the-progression-of-parkinsons-disease-pd---use-preclinical-human-trials-to-confirm-the-impact-of-the-optimal-probiotic-y7-tryptophan-and-branched-chain-amino-acid-cocktail-formula-on-early-stage-pd-patients-100639450","NCT07619560","Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease (PD) - Use Preclinical Human Trials to Confirm the Impact of the Optimal \"Probiotic Y7, Tryptophan and Branched-chain Amino Acid\" Cocktail Formula on Early Stage PD Patients","Developing Precision Microbiota-Based Cocktail Modification Therapy to Delay the Progression of Parkinson's Disease - Use Preclinical Human Trials to Confirm the Impact of the Optimal \"Probiotic Y7, Tryptophan and Branched-chain Amino Acid\" Cocktail Formula on Early Stage Parkinson's Disease Patient","Inclusion Criteria:\n\nSubject Inclusion Criteria:\n\n1. Age between 30-85 years old.\n2. Diagnosed with early-stage Parkinson's disease (Hoehn and Yahr scale stage 1-3).\n3. Brain MRI confirms striatal degeneration in the basal ganglia region, with no history of stroke.\n4. Responds to Parkinson's disease-related medications (e.g., Levodopa).\n5. Free of any major or acute illnesses.\n6. Able to comply with the 12 weeks intervention and required assessments for the study.\n\nExclusion Criteria:\n\n1. Unable to complete interviews or has mobility issues.\n2. Presence of major or acute illness before or during the study.\n3. Co-existing intestinal co-infections, such as CDI, E. coli, Salmonella, Shigella, Campylobacter, plague, or cytomegalovirus.\n4. Allergic to the intervention product.\n5. Pregnant or breastfeeding women.","30 Years","85 Years",{"count":52,"type":21},120,"INTERVENTIONAL",[55],"NA","Preclinical human trials will be utilized to validate the research direction, followed by clinical trials to assess the impact of a cocktail formula product containing the optimal probiotic Y7 combined metabolites on motor, cognitive, and non-motor functions in early Parkinson's disease patients. The study aims to recruit 120 patients (stage 1-3) and employ a two-arm, randomized controlled trial (RCT) design, dividing subjects into intervention and control groups for a 12 weeks trial period. Commercial development will be contingent upon the clinical trial outcomes, evaluating whether the product offers clinical benefits such as delaying Parkinson's disease progression in motor, cognitive, and non-motor functions. Additionally, a personalized and precise prognosis prediction model for Parkinson's disease will be established. This model will gather comprehensive clinical data, including motor function assessments (functional tests, UPDRS), biochemical markers, questionnaire responses, and genotype data (TPM array), as well as metabolite and microbial data. Through integrated analysis of this biological information using machine learning techniques, a personalized and accurate prognosis prediction model for Parkinson's disease will be developed. This model will predict the disease status of PD patients 12 weeks later, accounting for factors such as cocktail therapy. The results will empower PD patients to understand their individual disease progression and treatment prognosis, enabling them to prepare accordingly. Moreover, this model will aid researchers in identifying patient profiles more likely to benefit from treatment, thereby enhancing the evaluation of the efficacy and applicability of cocktail therapy.",[58,28,59],"Parkinson Disease (PD)","Probiotic",[61,62,63],"Parkinson's Disease","Probiotics","Gut microbiota","RECRUITING","2026-05-24",{"date":67,"type":33},"2026-06-02",{"date":69,"type":33},"2025-05-20",{"date":71,"type":21},"2027-08-31",{"name":73,"class":40},"Taipei Medical University",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":53,"phases":83,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":41},"100587550","organoid-models-of-hepatocellular-carcinoma-100587550","NCT06929845","Organoid Models of Hepatocellular Carcinoma","Organoid Models of Hepatocellular Carcinoma to Test Treatment Efficacy, Exploring Correlations With Tumor Microenvironment and Gut-liver-tumor Axis.","Inclusion Criteria:\n\n* Capacity to express informed consent;\n* Age ≥18 years;\n* Suspected radiological diagnosis of HCC or diagnosis of HCC with indications for surgical resection.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years;\n* Contraindications to liver biopsy (ascites, platelets\\\u003C50,000, INR\\>1.7);\n* Contraindications to HCC resection surgery;\n* Active viral infection;\n* Refusal to sign informed consent to participate in the study.",{"count":82,"type":21},150,[55],"A promising tool to elucidate the molecular characteristics of HCC are patient-derived organoids (PDOs), three-dimensional cultures of cells that self-organise according to tissue-specific patterns and can be used to test the susceptibility of a specific tumour to anticancer agents. In this study, PDOs for HCC will be developed that closely resemble the tumour microenvironment in vivo and mimic the crosstalk of the gut-liver axis to establish a correlation with patient prognosis and test the efficacy of available systemic therapies.",[86,87,28,88,89,90],"Hepatocellular Carcinoma","Organoids","Tumor Microenvironment","System Disorders, Digestive","Surgery","2026-05-18",{"date":93,"type":33},"2026-05-19",{"date":95,"type":33},"2024-10-01",{"date":97,"type":21},"2026-12-31",{"name":99,"class":40},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":101,"slug":102,"hasResults":12,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":107,"sex":108,"minAge":18,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":53,"phases":112,"briefSummary":113,"conditions":114,"keywords":124,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":41},"100629184","pesticides-and-infertility-oxidative-stress-via-circulating-cell-free-dna-and-gutgenital-microbiome-signatures-in-women-with-endometriosis-100629184","NCT07471373","Pesticides and Infertility: Oxidative Stress Via Circulating Cell-free DNA and Gut\u002FGenital Microbiome Signatures in Women With Endometriosis","PestiEndoMicro","Inclusion Criteria:\n\n* The \"case\" group will include:\n* All women aged 18 to 43, with confirmed endometriosis and endometriosis grade 3 or 4 as defined by the 1985 revised version of the American Society of Reproductive Medicine.\n* The \"control\" group will include:\n* All women aged between 18 and 43, whose infertility problem is proven male infertility and who do not have endometriosis identified by biological, genetic and clinical tests.\n* The following criteria will apply to both groups:\n* All women who have not received antibiotic treatment in the three months preceding inclusion and who are not participating in any pharmacological study.\n* All women who are covered under the national social security health insurance scheme.\n* All women who have signed a written informed consent form, thereby confirming their participation in the study after a period of free and informed reflection.\n\nExclusion Criteria:\n\n* All women aged 44 and over.\n* Women who are overweight, obese or anorexic.\n* Women taking antibiotics 3 months prior to inclusion, or participating in a drug study.\n* All women under anti-GnRH treatment, pregnant or suffering from a chronic inflammatory disease such as Crohn's disease, polycystic ovary syndrome, etc.\n* All women whose endometriosis has not been formally confirmed by the tests offered by the Reproductive Medicine and Biology Department, CECOS de Picardie, CHU Amiens-Picardie.\n* All patients under guardianship, curators or safeguard of justice.\n* All patients who have not signed the written consent confirming their participation in the study, after a period of free and informed reflection.\n* Any patient who withdraws her consent for participation in the study.",true,"FEMALE","43 Years",{"count":111,"type":21},160,[55],"This project PestiEndoMicro aims to provide an innovative approach, studying endometriosis under the genital and gut microbiota scope. To realize this project, the investigators are planning to dose cfDNA to assess the oxidative stress caused by endometriosis and study its epigenetics. At the same time, the investigators will take a pragmatic approach by assessing pesticide exposure in these patients and estimate the correlation between gut or genital dysbiosis and chemical agent exposure. Also, the investigators will take the initiative to use classic culture, qPCR techniques, and NGS to establish signatures in vaginal, endometrial and gut microbiota in patients with endometriosis. With these approaches, the goal is to gain more knowledge about endometriosis and optimize early diagnosis by establishing a signature in the genital and gut microbiota, but also by dosing the cfDNA. By doing so the investigators could open new opportunities to develop new therapeutic strategies for endometriosis.",[115,116,117,118,119,120,121,122,28,123],"Endometriosis","Infertility","Female Fertility","Cell Free DNA","Genital Microbiota","Vaginal Microbiota","Endometrial Microbiota","Pesticides","Epigenetics",[115,116,125,126,127,128,129,130,131,132],"Female fertility","cell free DNA","genital microbiota","vaginal microbiota","endometrial microbiota","pesticides","gut microbiota","epigenetics","2026-05-12",{"date":135,"type":33},"2026-05-15",{"date":137,"type":33},"2026-02-27",{"date":139,"type":21},"2028-05",{"name":141,"class":40},"Centre Hospitalier Universitaire, Amiens",{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":107,"sex":108,"minAge":150,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":53,"phases":153,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":167,"locationsCount":41},"100637190","effect-of-dairy-protein-yogourt-vs-plant-based-yogourt-on-body-weight-body-composition-bone-health-and-gut-microbiota-100637190","NCT07578103","Effect of Dairy Protein Yogourt vs Plant-based Yogourt on Body Weight, Body Composition, Bone Health and Gut Microbiota","A New Focus on Protein and the Gut Microbiota to Explain Health Benefits of Dairy Foods","PROYO","Inclusion Criteria:\n\n* Postmenopausal women (absence of menstruation for at least 1 year and FSH \\> 40 IU\u002FL)\n* BMI between 27.0 and 39.9 kg\u002Fm²\n* Sedentary or moderately active\n\nExclusion Criteria:\n\n* Body weight change greater than 5 kg in the 3 months preceding the study\n* Currently dieting or following specific dietary patterns\n* Previous or planned bariatric surgery\n* Food allergies or intolerances (particularly dairy proteins and lactose)\n* Serious or problematic health conditions (e.g., renal insufficiency, diabetes, Cushing's disease, Paget's disease, parathyroid disorders, inflammatory bowel disease, uncontrolled thyroid disease, etc.)\n* Fracture within the past year\n* Hormone therapy\n* Medications affecting bone metabolism (e.g., osteoporosis treatments, anti-estrogen therapy for breast cancer, epilepsy treatments)\n* Antibiotic use within the 6 months preceding the study\n* Use of probiotic supplements (capsules)\n* More than two alcoholic drinks per day\n* Smoking\n* Drug abuse","40 Years",{"count":152,"type":21},75,[55],"The consumption of an adequate quantity of protein in the diet is essential to maintain a healthy body composition and functioning. It is also well established that all proteins are not equal regarding their ability to promote health benefits. Recently, we have innovated in that matter by showing that under the context of high intake of dietary fat, the dairy protein casein was more effective than a mix of proteins representative of a western diet to prevent body weight gain and insulin resistance. This was explained in part by modifications of the gut microbiota. This finding represents the main conceptual basis of the present research program that is aimed to determine the impact of dairy protein from yogurt compared to a plant-based equivalent on body composition indicators including muscle mass and bone mineral density, in relation to the profile of the gut microbiota, the production of newly discovered protein-derived metabolites, and markers of metabolic health. This program will include a human and an animal component requiring the testing of these variables before and after a standardized intervention. The human component will be a clinical study consisting of a 12-week diet-based weight loss intervention in postmenopausal overweight women being randomly assigned to one of the three following groups: yogurt, plant-based yogurt, or kept on diet without supplements. The animal experimentation will permit to causally determine the implication of the gut microbiota in the protein effects following transfer of the human bacteria to germ free mice and validate the benefits seen in humans. It is anticipated that these two complementary investigative approaches will allow a thorough documentation of the impact of fermented dairy protein on body composition and functioning, a better understanding of the underlying mechanisms, and the identification of new biomarkers to better appreciate related health benefits.",[156,157,158,159,160,28],"Body Composition Changes","Body Weight Change","Metabolic Health","Bone Metabolism","Bone Health","2026-05-05",{"date":163,"type":33},"2026-05-11",{"date":165,"type":33},"2023-11-01",{"date":97,"type":21},{"name":168,"class":40},"Laval University",{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":107,"sex":17,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":181,"conditions":182,"keywords":186,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":199},"100636600","gbpdc-gut-brain-in-pd-consortium-master-protocol-100636600","NCT07567794","GBPDC: Gut-Brain in PD Consortium Master Protocol","Consortium for Gut-Brain Communication in Parkinson's Disease Master Protocol","GBPDC","Inclusion Criteria (All PD Cohorts)\n\n1. Aged ≥21 years old and ≤80 years old\n2. Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria\n3. Adequate visual, hearing, cognitive, and physical ability\n4. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Because longitudinal participation is important to the scientific goals of the program, a \"best estimate\" of interest, commitment, and geographic feasibility for three years will be documented by the enrolling investigator after interview with the potential enrollee\n\nInclusion Criteria Controls\n\n1. Aged ≥21 years old and ≤80 years old\n2. No known or diagnosed neurodegenerative disease\n3. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures\n4. Resides within the same household as person with PD\n\nInclusion Criteria Prodromal Cohort\n\n1. Aged ≥21 years old and ≤80 years old\n2. Prodromal characteristics are defined by the MDS Research Criteria for PD and include either polysomnography (PSG)-confirmed rapid eye movement sleep behavior disorder (RBD) or possible RBD (questionnaire-based), with hyposmia as defined by the University of Pennsylvania Smell Identification Test (UPSIT) ≤ 15th percentile.\n\nExclusion Criteria (All Cohorts)\n\n1. Diagnosis of secondary or atypical parkinsonism\n2. Laboratory Values:\n\n   1. Hemoglobin (Hgb) \\\u003C10\n   2. Platelets \\\u003C70,000\n   3. Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \\> 2 1\u002F2 times upper limit of normal (ULN)\n   4. Moderate or severe renal disease with an estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002FBSA \\[body surface area\\]) calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation, or moderate or severe hepatic impairment (alkaline phosphatase \\[ALP\\] \\>2.0 times the ULN and\u002For total bilirubin \\>2.0 times the ULN)\n   5. Significantly above the normal range for PT\u002FINR\u002FPTT\n3. Currently taking anticoagulants that are deemed exclusionary by the investigator for risk of bleeding with sigmoidoscopy procedure\n4. Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score \\\u003C22\n5. Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than PD, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Creutzfeld-Jakob- Disease, Down's syndrome, cortico-basal degeneration, dementia with Lewy Bodies, Alzheimer's disease, amyotrophic lateral sclerosis, seizure disorder, stroke, or other infectious, metabolic, or systemic disease affecting the central nervous system including, but not limited to, syphilis, present hypothyroidism, present or unaddressed\u002Ftreated vitamin B12 deficiency, or other screening laboratory abnormalities\n6. Suicidality, defined as active suicidal thoughts or ideation within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide\n7. Has cancer or has had a malignant tumor within the past 5 years. (Participants with stable untreated prostate cancer or treated\u002Fremoved cutaneous carcinomas are not excluded.)\n8. Any medical condition or systemic disease that, in the Investigator's opinion, may either put the participant at risk because of participation in the study, influence the results or proposed analyses, or impair the participant's ability to fully participate in the study\n9. Body mass index (BMI) \\>35 kg\u002Fm2 or body weight \\\u003C50 kg\n10. Participant is currently pregnant, breastfeeding, and\u002For lactating\n11. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)\n12. History of Covid 19 (SARS-CoV-2) infection within 6 weeks prior to screening.\n13. Participants with unresolved symptoms of Covid 19 infection or ongoing cognitive or other deficits attributable to post-Covid 19 that may affect participant safety or interfere with cognitive assessments based on the Investigator's clinical judgment\n14. Either ongoing or current participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken. Participation in other research studies (e.g., observational studies) may be acceptable throughout this study.\n15. History of GI surgery. (However, patients with appendicectomy, hemorrhoid surgery, and cholecystectomy will be eligible to participate).\n16. Regular use of medication that impacts the intestinal barrier (e.g., NSAID more than 3 times weekly)\n17. Has a history of Crohn's disease, ulcerative colitis, and\u002For other types of colitis (microscopic, lymphocytic, or collagenous colitis). Confirmed diagnosis of inflammatory bowel disease (IBD) and\u002For, active or uncontrolled IBD symptoms such as diarrhea, bleeding, or severe stomach pain. Treatment for IBD in the past 6 months with medicines such as steroids, biologics, or strong immune-suppressing drugs. Surgery to remove part of the bowel due to IBD. Other long-term gut diseases that cause inflammation, such as celiac disease.","21 Years","80 Years",{"count":180,"type":21},250,"The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study.\n\nDuring this study, specific groups of participants, also known as \"cohorts\", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection.\n\nParticipants in this study will:\n\n* meet with a medical provider\n* answer questionnaires\n* give samples of blood, stool, and saliva\n* have X-rays taken while swallowing different foods (swallowing study)\n* have X-rays taken to see how long it takes markers to move through their colon (colon transit study)\n* have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining)\n* have samples taken of their skin\n* have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function.\n\nParticipation in the study will last up to 24 months (2 years).",[58,183,184,28,185],"PARKINSON DISEASE (Disorder)","Gut Microbiome","Prodromal Parkinsons Disease",[187,188,189,190],"gut brain","Parkinson's disease","Prodromal Parkinson's disease","healthy control","2026-04-29",{"date":161,"type":33},{"date":194,"type":21},"2026-06-04",{"date":196,"type":21},"2028-12-31",{"name":198,"class":40},"Duke University",7,{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":107,"sex":17,"minAge":18,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":53,"phases":211,"briefSummary":212,"conditions":213,"keywords":218,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":41},"100635534","sustainable-and-inclusive-use-of-alternative-proteins-in-mediterranean-supply-chains-cipromed-100635534","NCT07553936","Sustainable and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)","Circular and Inclusive Use of Alternative Proteins in Mediterranean Supply Chains (CIPROMED)","CIPROMED","Inclusion Criteria:\n\n* Providing signed informed consent,\n* Being between 18 and 65 years of age,\n* Having a body mass index (BMI) within the normal range, defined as between 18.5 and 24.9 kg\u002Fm² or Having a body mass index (BMI) between 25.0 and 34.9 kg\u002Fm², inclusive, corresponding to the overweight category or, at most, class I obesity.\n\nExclusion Criteria:\n\n* Positive and documented history of allergy to legumes, insects, microalgae, shellfish, mollusks, crustaceans, snails, insect venom, house dust mites, or any component (ingredient or additive) present in the food prototypes tested, or a confirmed or suspected diagnosis of Celiac Disease.\n* History of severe allergic reactions to any type of allergen.\n* Pregnancy or Breastfeeding","65 Years",{"count":210,"type":21},40,[55],"This study investigates the effects of foods enriched with alternative protein sources, including edible insects, microalgae, hemp, and legumes, on appetite regulation, satiety, food preferences, and metabolic health in healthy adults and individuals with overweight. The study is part of the CIPROMED project, which aims to support sustainable and circular food systems in the Mediterranean area.\n\nThe study consists of two phases. In the acute phase, participants will consume different protein-enriched bread products in a controlled setting following a randomized crossover design. Each participant will be exposed to multiple test conditions, allowing within-subject comparisons of postprandial responses. Outcomes assessed during this phase include satiety, hunger, food preference, craving, and short-term energy intake, measured using validated scales and dietary assessment tools.\n\nIn the chronic phase, participants will follow structured dietary interventions over a longer period within a Mediterranean dietary framework. Participants will be assigned to different dietary patterns including alternative protein-based foods and control products. This phase aims to evaluate the effects of repeated consumption of alternative protein sources on metabolic parameters, gastrointestinal tolerance, nutritional status, and behavioral responses.\n\nThe study aims to assess the acceptability and physiological effects of alternative protein sources and to compare their impact with that of traditional protein sources commonly used in Mediterranean diets.",[214,215,216,217,28],"Food Preferences","Satiety and Food Intake","Appetite Regulation","Overweight (BMI > 25)",[219,220,221,222,216,223,224,225,226,227,158,28],"Alternative Proteins","Edible Insects","Hemp Protein","Legume Protein","Overweight","Novel Foods","Microalgae (Protein)","Food Acceptability","Satiety","2026-04-28",{"date":230,"type":33},"2026-05-04",{"date":232,"type":33},"2026-03-18",{"date":234,"type":21},"2027-01-31",{"name":236,"class":40},"University of Bologna",{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":150,"maxAge":178,"enrollmentInfo":244,"targetDuration":4,"studyType":53,"phases":246,"briefSummary":247,"conditions":248,"keywords":251,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":41},"100584967","fiber-smoothie-supplement-100584967","NCT06896240","Fiber Smoothie Supplement","The Impact of a Daily Whole Food Plant-based Smoothie Utilization 2 Weeks Prior to Revision Total Knee Replacement Surgery on Inflammation and Post-operative Pain.","Inclusion:\n\n* Scheduled for revision TKA at HSS with participating surgeons; not as a result of infection or trauma and all components (tibial and femoral) needing replacement\n* Age between 40 and 80\n* Diagnosed with osteoarthritis\n* Diagnosed with 2+ modifiable chronic lifestyle diseases: Type 2 DM, CVD (such as CAD, heart disease, stroke, HTN), stress, anxiety, depression, ADHD, metabolic syndrome, certain types of cancer (such as breast, colorectal, lung, prostate), Alzheimer's disease, vascular cognitive impairment, CKD, RA, asthma, chronic pain conditions (such as chronic back pain and osteoarthritis), fibromyalgia, migraines, COPD (Steiber 2011, Grant 2014)\n* ASA Class 1 ('normal' healthy patient) or 2 (patient with mild systemic disease and no functional limitations; the diseases the patient has are well controlled)\n* Ability to understand written and spoken English\n* Willing to complete entire pre-operative and post-operative work up in NYC, main campus site\n* Willing to follow a 2-week smoothie supplement, including willingness to purchase ingredients and have access to a blender for preparation\n\nExclusion:\n\n* Age \\>80 years or \\\u003C40 years\n* Revision due to infection or trauma\n* ASA class 3 (patient with severe systemic disease that results in functional limitations) or 4 (patient with severe systemic disease that is a constant threat to life)\n* Not interested or unable to provide informed consent\n* Unstable weight (\\>5kg weight change in the past 3 months, documented in Epic) or currently on weight loss drugs such as GLP-1 agonists (Prasad et al., Cardiovasc Diabetol 2022; empagliflozin CRP studies.)\n* Active infection, flare-up of seasonal allergies, or physical trauma (all can alter CRP)\n* Medication changes the month leading up to surgery\n* Specifically medications altering inflammation: Statins (Ridker 2008), steroids (Boumpas et al., Ann Intern Med 1993; glucocorticoid cytokine modulation research.), DMARDS\u002Fbiologics\u002Fimmunosuppressants (Clinical rheumatology guidelines, biologic RCTs (e.g., TNF inhibitors, IL-6 inhibitors), Colchicine (Tardif et al., N Engl J Med 2019; colchicine cardiovascular inflammation studies.), hormone replacement therapies (Ridker et al., JAMA 1999; OCs and CRP meta-analyses.), new psychiatric medications (Miller \\& Raison, Nat Rev Immunol 2016; psychotropic-inflammation associations.)\n* BMI \\>40 kg\u002Fm2\n* Food intolerance\u002Fallergy\u002Fsensitivity to ingredients suggested for smoothies\n* History of IBD (and IBD medication)\n* History of bariatric surgery\n* History of cancer\n* History of thyroid disease\n* History of or current drug abuse\n* Pregnancy\n* Current smoker\n* Any patient with an electronic cardiac implant",{"count":245,"type":21},24,[55],"This study aims to assess the feasibility of a 2-week dietary whole-food smoothie intervention and compare outcomes between two groups: patients that integrated a daily whole food plant-based smoothie into their diet for two weeks prior to surgery, and a control group of revision TKA patients that made no nutritional changes to their diet prior to surgery. The main research questions are:\n\n1. Among patients planned for elective TKA revision surgery, what is the feasibility of a 2-week dietary intervention implemented 2 weeks prior to surgery? \\[Outcomes will be compliance, noted barriers and\u002For facilitators, satisfaction with diet\\]\n2. Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will reduce inflammation -measured in plasma levels of IL-6 and CRP- at POD0, POD1, POD2, POD3, and 6 Weeks Post-operative as compared to 1) baseline (prior to dietary intervention initiation) and 2) control patients who did not make changes in their diet prior to surgery.\n3. Determine if the implementation of a daily whole food plant-based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in quantifiable changes in the gut microbiome composition -measured via fecal samples- as compared to control patients who did not make changes in their diet prior to surgery.\n4. Determine if the implementation of a daily whole food plant- based smoothie dietary supplement 2 weeks prior to TKA revision surgery will result in improved immediate postoperative pain -measured through numeric rating scale (NRS) pain scores- and opioid use -measured in morphine milligram equivalents (MME)- as compared to control patients.\n5. Compare patient satisfaction and adoption of nutritional behavioral changes in patients implementing a whole food plant-based smoothie 2 weeks prior to TKA revision surgery to patients undergoing the same surgery but did not me pre-surgery dietary changes.\n\nThe researcher's primary outcome is measuring feasibility and patient compliance with smoothie consumption. Secondarily, the investigators are interested in measuring if the preoperative smoothie can alter the gut microbiome and decrease systemic inflammation, leading to lowered post-operative pain and opioid use.",[249,250,28],"Total Knee Arthroplasty Revision","Inflammatory Markers",[252,253,254,184],"TKA Revision","Inflammation","Diet","2026-04-23",{"date":228,"type":33},{"date":258,"type":21},"2026-05",{"date":260,"type":21},"2028-01-01",{"name":262,"class":40},"Hospital for Special Surgery, New York",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":17,"minAge":270,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":53,"phases":273,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":41},"100593746","microbiota-gut-brain-axis-in-resistant-epilepsy-100593746","NCT07010445","MiCrobiota-gut-brain Axis in Resistant Epilepsy","CARE","Inclusion criteria:\n\n* 3-50 years old;\n* diagnosis of epilepsy at onset or DRE;\n* ensured participation of the patient or a caregiver;\n* willingness to sign the informed consent.\n\nExclusion criteria:\n\n* diagnosis of organic gastrointestinal disorders (e.g. chronic inflammatory bowel disease);\n* special diets;\n* use of antibiotics, corticoids or probiotics in the previous month.","3 Years","50 Years",{"count":52,"type":21},[55],"Epilepsy is one of the most common neurological chronic conditions with a serious burden on patients, their caregivers, and society. Drug-resistant epilepsy (DRE) heightens this burden. New approaches are thus a priority. Studies in animal models and humans have shown the link between gut microbiota (GM) and the central nervous system in health, neurological conditions, and neurodevelopmental disorders. DRE has been linked to GM dysbiosis. Preliminary findings in children with DRE showed GM modifications when responding to a ketogenic diet. The mediator role of GM has not yet been studied in DRE patients undergoing surgery\u002Fvagal nerve stimulation.\n\nCARE's central hypothesis is that the GM and its metabolic profile could contribute to clinical outcomes following these different therapeutic procedures. Identifying microbial biomarkers will enable us to deepen the knowledge of the role of gut-brain axis in epilepsy and to tailor the intervention to each patient based on GM modulation.",[28,276,277],"Epilepsy","Drug-Resistant Epilepsy","2026-04-06",{"date":280,"type":33},"2026-04-09",{"date":282,"type":33},"2024-08-16",{"date":284,"type":21},"2027-02",{"name":286,"class":40},"Niguarda Hospital",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":294,"maxAge":295,"enrollmentInfo":296,"targetDuration":4,"studyType":53,"phases":298,"briefSummary":299,"conditions":300,"keywords":308,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":41},"100582737","peanuts-for-cardiometabolic-brain-and-intestinal-health-100582737","NCT06867198","Peanuts for Cardiometabolic, Brain, and Intestinal Health","Impact of Peanuts on Cardiometabolic, Cognitive, and Intestinal Health in Prediabetes Among Racially Diverse Populations","Inclusion Criteria:\n\n* men and women\n* 20-59 years of age\n* BMI: 24.5 - 35.5 kg\u002Fm\\^2\n* Prediabetes (fasting blood glucose levels 100-125 mg\u002FdL and\u002For HbA1c between 5.7-6.4%)\n* Ability to give consent\n\nExclusion Criteria:\n\n* Allergies to peanuts and peanut products\n* Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs\n* Active cancer, gastrointestinal, renal, cardiovascular, thyroid, and neurological diseases or severe head injury\n* Smoking\n* Consumes greater than 2 alcoholic beverages per day\n* Consumes antioxidant, probiotic, and prebiotic supplements\n* Pregnant or Lactating\n* Actively participating in a weight loss program\n\nMRI Exclusion Criteria:\n\n* Certain neurological disorders (e.g., uncontrolled seizure disorders)\n* Braces on their teeth, a cardiac pacemaker; hearing aid; other metal in the body or eyes (which may include certain metallic-embedded tattoos), including but not limited to pins, screws, shrapnel, plates, dentures or other metal objects","20 Years","59 Years",{"count":297,"type":21},72,[55],"The overall objective of this 14-month randomized crossover study is to seek evidence demonstrating that daily consumption of peanuts and peanut products improve cardiometabolic, cognitive, and intestinal health in a racially diverse prediabetes population.",[301,302,303,304,28,305,306,307],"Prediabetes","Prediabetes (Insulin Resistance, Impaired Glucose Tolerance)","Cognition","Microvascular Function","Endothelial Function (Reactive Hyperemia)","Arterial Stiffness, Blood Pressure","Adult",[309,310,311,312,313,314,315,316,317,318,319,320,321,322,131],"prediabetes","peanuts","functional foods","nuts","metabolic health","insulin resistance","type II diabetes","microvascular function","dietary intervention","cognitive function","vascular function","neuroimaging","endothelial function","cardiovascular health","2026-03-23",{"date":325,"type":33},"2026-03-27",{"date":327,"type":33},"2025-03-06",{"date":329,"type":21},"2027-09",{"name":331,"class":40},"Georgia State University",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":108,"minAge":294,"maxAge":208,"enrollmentInfo":339,"targetDuration":4,"studyType":53,"phases":340,"briefSummary":341,"conditions":342,"keywords":347,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":41},"100572621","wild-blueberries-for-gut-brain-and-cardiometabolic-health-in-prediabetes-100572621","NCT06735651","Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Prediabetes","Wild Blueberries for Gut, Brain, and Cardiometabolic Health in Female Adults With Prediabetes.","Inclusion Criteria:\n\n* Women aged 20-65 years old\n* Prediabetes (fasting blood glucose 100-125 mg\u002FdL and\u002For HbA1c percentage between 5.7-6.4)\n* Body Mass Index between 25-30 kg\u002Fm\\^2\n\nExclusion Criteria:\n\n* Allergies to berries\n* Use of insulin, antidiabetic, antibiotics, and anti-inflammatory drugs\n* Active cancer, gastrointestinal, renal, thyroid, stage 1 \\& 2 hypertension and other cardiovascular diseases, neurological diseases, or severe head injury\n* Smoking\n* Consumes greater than 2 alcoholic beverages per day\n* Consumes antioxidant, probiotic, and prebiotic supplements\n* Pregnant or Lactating\n* Actively participating in a weight loss program\n* Currently taking berry supplements or recently participated in another study taking berry supplements",{"count":5,"type":21},[55],"The goal of this clinical trial is to determine the effectiveness of using a freeze-dried wild blueberry powder on cardiometabolic health, cognitive function, and gut microbiota composition in adult women with prediabetes.",[302,343,307,305,344,303,345,28,223,253,304,346],"Female","Arterial Stiffness","Oxidative Stress","Body Composition",[348,301,349,350,351,352,353,354,355,63,356,357,304,358],"Blueberries","Insulin Resistance","Functional foods","Dietary intervention","Endothelial function","Vascular function","Cardiovascular health","Metabolic health","Cognitive function","Type II diabetes","Wild Blueberries",{"date":360,"type":33},"2026-03-25",{"date":362,"type":33},"2024-09-20",{"date":364,"type":21},"2026-06-01",{"name":331,"class":40},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":107,"sex":17,"minAge":373,"maxAge":18,"enrollmentInfo":374,"targetDuration":4,"studyType":53,"phases":375,"briefSummary":376,"conditions":377,"keywords":380,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":41},"100629584","clinical-trial-of-lactiplantibacillus-plantarum-dad-13-on-gut-microbiota-profile-and-performance-in-adolescent-athletes-100629584","NCT07476573","Clinical Trial of Lactiplantibacillus Plantarum Dad-13 on Gut Microbiota Profile and Performance in Adolescent Athletes","Dad-13","Inclusion Criteria:\n\n* Residing in the BPPLOP dormitory of Central Java Province;\n* Having a normal body mass index;\n* Being an athlete in an endurance sport;\n* Having no growth disorders\n\nExclusion Criteria:\n\n* Injury, any health contraindication or failure to perform exercise procedures;\n* Gastrointestinal infections, diseases, disorders;\n* Past history of gastrointestinal surgery;\n* Failure to follow the study protocol;\n* Declared general feeling of being unwell","12 Years",{"count":5,"type":21},[55],"The aim of this research is to analyze the effect of a Lactiplantibacillus plantarum Dad-13 supplementation on the gut microbiota profile and performance of adolescent athletes.",[378,59,379,28],"Athlete","Performance",[381,382,383,131],"athlete","probiotic","performance","2026-03-19",{"date":323,"type":33},{"date":387,"type":21},"2026-04-13",{"date":389,"type":21},"2026-08-30",{"name":391,"class":40},"Gadjah Mada University",{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":271,"maxAge":178,"enrollmentInfo":400,"targetDuration":4,"studyType":53,"phases":401,"briefSummary":402,"conditions":403,"keywords":408,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":41},"100593652","lifestyle-interventions-to-prevent-cognitive-deficits-in-subjects-with-depressive-symptoms-from-mechanisms-to-clinical-practice-100593652","NCT07009223","Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice","Lifestyle Interventions to Prevent cOgnitive Deficits in Subjects With Depressive Symptoms: From mEchanisms to Clinical pRactice","POWER","Inclusion Criteria:\n\n* Aged between 50 and 80 years;\n* Diagnosis of DDM according to DSM-5 or depressive symptoms (PHQ-9 or GDS-15 ≥ 5, the choice of test will be justified by the participant's age);\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Active gastrointestinal disorders;\n* Autoimmune disorders;\n* Chronic inflammatory disorders;\n* Diagnosis of dementia; cognitive impairment or mild functional impairment.\n* Use of antibiotics and\u002For anti-inflammatory drugs in the 8 weeks prior to the screening visit.",{"count":52,"type":21},[55],"The goal of this clinical study is to investigate if lifestyle changes can help prevent cognitive decline and reduce depressive symptoms in people between the ages of 50 and 80 with depressive symptoms or a diagnosis of major depression, but without signs of cognitive decline.\n\nThe main questions it aims to answer are:\n\n* Does regular physical activity improve mood and memory in people who are depressed or have depressive symptoms?\n* Does cognitive training help prevent mental difficulties in people at risk of cognitive decline?\n* Do changes in diet and lifestyle alter the composition of the gut microbiota and immuno-related infiammatory factors?\n\nResearchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health.\n\nThe participants:\n\n* Will take part to online sessions on healthy eating based on the Mediterranean diet\n* Some will do regular exercise, supervised by a personal trainer\n* Others will do weekly cognitive training in small groups at the hospital\n* They will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the beginning, at the end of the treatment (12 weeks), and after 3 months.",[404,405,253,406,28,407],"Major Depressive Disorder (MDD)","Physical Activity","Metabolome","Depressive Symptoms",[409,303,410],"Depression","nutrition","2026-02-09",{"date":413,"type":33},"2026-02-11",{"date":415,"type":33},"2025-10-01",{"date":417,"type":21},"2028-03",{"name":419,"class":40},"IRCCS Centro San Giovanni di Dio Fatebenefratelli",{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":427,"targetDuration":429,"studyType":23,"phases":4,"briefSummary":430,"conditions":431,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":41},"100623724","the-efficacy-of-pd-1-monoclonal-antibody-combined-with-chemotherapy-in-metastatic-gastric-cancer-based-on-gut-microbiota-100623724","NCT07400354","The Efficacy of PD-1 Monoclonal Antibody Combined With Chemotherapy in Metastatic Gastric Cancer Based on Gut Microbiota","A Study on the Assessment of the Efficacy of PD-1 Monoclonal Antibody Combined With Chemotherapy in Metastatic Gastric Cancer Based on Gut Microbiota","Inclusion Criteria:\n\n* Age ≥ 18 years, gender not restricted;\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0-2, with -an expected survival period of more than 3 months;\n* Metastatic or locally advanced gastric cancer confirmed by cytology or histopathology;\n* Laboratory test data within 7 days before screening (including 7 days) should meet the following requirements: neutrophil count ≥ 1.5×109\u002FL, platelet count ≥ 80×109\u002FL, hemoglobin ≥ 80g\u002FL, total serum bilirubin ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 x ULN, if liver metastasis is present, ALT and AST ≤ 5 x ULN; albumin ≥ 30g\u002FL; serum creatinine ≤ 1.5 x ULN or creatinine clearance rate (CCr) ≥ 60ml\u002Fmin.\n* At least one evaluable lesion (according to RECIST 1.1 criteria);\n* No previous palliative chemotherapy and planned for first-line immunotherapy (nivolumab, sintilimab, tislelizumab, pembrolizumab as recommended by guidelines, specifically determined by the attending physician) combined with chemotherapy (FOLFOX, XELOX, SOX, specifically determined by the attending physician), and combination with fruquintinib is allowed (only for patients enrolled in the trial with the number HMPL-013-SH-GC103);\n* The subject (or their legal representative\u002Fguardian) must sign the informed consent form, indicating that they understand the purpose of this study, are aware of the necessary procedures, and are willing to participate in this study.\n\nExclusion Criteria:\n\n* Pregnant or lactating women, and women of childbearing age who have not taken adequate contraceptive measures;\n* Patients with a history of other malignant tumors within 5 years, except for those with a history of cured cervical carcinoma in situ or non-melanoma skin cancer; Patients with primary brain tumors or central nervous system metastases that are not under control, and those with obvious intracranial hypertension or neuropsychiatric symptoms;\n* Patients with the following severe or uncontrolled diseases: severe heart disease, unstable condition despite treatment, myocardial infarction, congestive heart failure, unstable angina pectoris, significant pericardial effusion or unstable arrhythmia within 6 months before enrollment; definite neurological or psychiatric disorders, including dementia or epileptic seizures; severe or uncontrolled infections; active disseminated intravascular coagulation, or patients with obvious bleeding tendencies;\n* Patients with significant damage to important organs;\n* Patients with pleural effusion or ascites causing respiratory syndrome (≥CTCAE grade 2 dyspnea) requiring local treatment;\n* Other conditions where the investigator deems the patient unsuitable for participation in this trial;\n* Patients who have been taking probiotics or antibiotics for a long time.",{"count":428,"type":21},300,"2 Years","This study is designed as a single-center, open-label, phase II exploratory trial. Patients with advanced or locally advanced gastric cancer who have not received chemotherapy or immunotherapy before are eligible for inclusion. They will receive a first-line two-drug combination chemotherapy regimen (FOLFOX, XELOX, or SOX, determined by the attending physician) in combination with a PD-1 monoclonal antibody (nivolumab, sintilimab, tislelizumab, or pembrolizumab, determined by the attending physician). Fruquintinib can be added on this basis (only for patients enrolled in the HMPL-013-SH-GC103 study). The aim is to evaluate whether the gut microbiota has a predictive role in the efficacy of immunotherapy combined with chemotherapy for metastatic gastric cancer. A total of 100 patients will be enrolled in the study.\n\nGut microbiota will be measured at the following three time points:\n\n1. Within 3 days before the first chemotherapy (designated as time 0)\n2. Within 3 days before the third chemotherapy (designated as time 1)\n3. After the sixth chemotherapy cycle, or within 1 week after disease progression if it occurs within the sixth cycle (designated as time 2)",[432,28],"Gastric Cancer","2026-02-03",{"date":435,"type":33},"2026-02-10",{"date":437,"type":33},"2024-03-14",{"date":439,"type":21},"2027-12-31",{"name":441,"class":40},"Fudan University",{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":107,"sex":17,"minAge":18,"maxAge":208,"enrollmentInfo":450,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":452,"conditions":453,"keywords":457,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":469,"locationsCount":41},"100622247","bariatric-surgery-and-gut-microbiota-changes-over-time-100622247","NCT07381140","Bariatric Surgery and Gut Microbiota Changes Over Time","Longitudinal Evaluation of Gut Microbiota and Fecal Metabolome Following Roux-en-Y Gastric Bypass: Clinical Implications and Identification of Predictive Biomarkers","RYGB-MICROGUT","Inclusion Criteria (RYGB Group):\n\n* Age between 18 and 65 years.\n* Adults with a body mass index (BMI) ≥ 35 kg\u002Fm² with related comorbidities, or BMI ≥ 40 kg\u002Fm², who are candidates for Roux-en-Y gastric bypass (RYGB) surgery only.\n\nExclusion Criteria (RYGB Group):\n\n* Treatment with antibiotics within the last 3 weeks, or probiotics\u002Fprebiotics within the last 4-6 weeks, or systemic corticosteroids within the 8 weeks prior to baseline (T0).\n* Participation in dietary regimens or calorie restriction programs in the weeks prior to enrollment.\n* Chronic inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), ongoing enteric infections, or active neoplasms.\n* Previous organ transplant or ongoing systemic immunosuppressive therapy.\n* Pregnancy or breastfeeding.\n* Previous major gastrointestinal surgery.\n* Chronic alcohol consumption above moderate levels or substance use disorder.\n\nInclusion Criteria (Obese Control Group):\n\n* Age between 18 and 65 years.\n* Adults with BMI ≥ 30 kg\u002Fm² who are candidates for structured dietary treatment.\n\nInclusion Criteria (Healthy Control Group):\n\n* Age between 18 and 65 years.\n* Normal weight (BMI between 18.5 and 24.9 kg\u002Fm²).\n* Normal metabolic function: fasting glucose below threshold, normal ALT\u002FAST, no diagnosis of diabetes or metabolic syndrome.\n* No chronic gastrointestinal diseases or conditions that could alter the gut microbiota.\n\nExclusion Criteria (Obese Control and Healthy Control Group):\n\n* Use of antibiotics within the last 3 weeks or probiotics\u002Fprebiotics within the last 4-6 weeks.\n* Recent gastrointestinal surgery.\n* Pregnancy or breastfeeding.\n* Extreme diets or recent dietary changes.\n* Recent international travel that could have affected the gut microbiota.\n* Medications known to influence the gut microbiota (e.g., PPIs, metformin, steroids).\n* Active smoking or excessive alcohol consumption.\n* Significant gastrointestinal symptoms (chronic diarrhea or constipation).",{"count":451,"type":21},100,"The goal of this observational study is to learn how bariatric surgery affects gut bacteria and gut-related metabolic products over time in adults with obesity. The study includes adults aged 18 to 65 years who are undergoing Roux-en-Y gastric bypass (RYGB) surgery, as well as adults with obesity treated with diet alone and healthy normal-weight adults.\n\nThe main questions it aims to answer are:\n\nHow does bariatric surgery change the composition and diversity of gut bacteria over time? How are these changes related to weight loss and improvement of obesity-related health conditions?\n\nResearchers will compare people undergoing bariatric surgery with people with obesity treated with diet alone and with healthy normal-weight individuals to see if surgery leads to specific changes in gut bacteria and stool metabolites that are linked to better clinical outcomes.\n\nParticipants will:\n\nProvide stool samples at scheduled time points over 12 months Provide blood samples and undergo routine clinical assessments Take part in follow-up visits to monitor weight, metabolic health, and gastrointestinal symptoms",[454,455,28,456],"Obese Patients","Obese Patients With Bariatric Surgery","Healthy Participants",[131,458,459,460,461,462],"stool metabolome","obesity","bariatric surgery","Roux-en-Y gastric bypass","Long-read sequencing",{"date":464,"type":33},"2026-02-05",{"date":466,"type":21},"2026-04",{"date":468,"type":21},"2028-04",{"name":470,"class":40},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis",{"id":472,"slug":473,"hasResults":12,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":107,"sex":17,"minAge":150,"maxAge":478,"enrollmentInfo":479,"targetDuration":4,"studyType":53,"phases":480,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":41},"100620260","high-dairy-food-patterns-and-gut-brain-axis-100620260","NCT07355309","High-Dairy Food Patterns and Gut-Brain Axis","Longer-term Effects of High-dairy Food Patterns on the Gut-brain Axis in Adults With Overweight or Obesity","Inclusion Criteria:\n\n* Men and postmenopausal women (≥ 2 years since last menstruation);\n* Aged between 40-75 years;\n* BMI between 25-35 kg\u002Fm2 (overweight or obese);\n* Low-to-moderate habitual dairy consumption (≤ 3 servings\u002Fday);\n* Fasting serum total cholesterol \\\u003C 8.0 mmol\u002FL;\n* Fasting serum triacylglycerol \\\u003C 4.5 mmol\u002FL;\n* Fasting plasma glucose \\\u003C 7.0 mmol\u002FL;\n* Systolic blood pressure \\\u003C 160 mmHg and diastolic blood pressure \\\u003C 100 mmHg;\n* Stable body weight (weight gain or loss \\\u003C 3 kg in the past three months).\n\nExclusion Criteria:\n\n* Left-handedness;\n* Milk protein allergy or lactose intolerance;\n* Current smoker, or smoking cessation \\\u003C 12 months;\n* Familial hypercholesterolemia;\n* Abuse of drugs;\n* Alcoholic intake \\>3 standard drinks\u002Fday;\n* Use of medications, food products or dietary supplements affecting glucose, lipid, or blood pressure regulation, gut microbiota or mental or neurological function, judged by the principal investigator;\n* Use of antibiotics within the previous month;\n* Use of other biomedical investigational products within the previous month;\n* Participation in another clinical trial within the past month;\n* Severe medical conditions including type 2 diabetes, epilepsy, asthma, kidney failure, COPD, inflammatory bowel disease, autoimmune diseases, or rheumatoid arthritis;\n* History of cardiovascular events (e.g., heart attack, stroke) or active cardiovascular disease;\n* Contra-indications for MRI imaging (e.g. pacemaker, metal implants, claustrophobia);\n* Willing to donate blood starting from 8 weeks before the study begins, throughout the study, and for 4 weeks after its inclusion;\n* Difficult to venipuncture as evidenced during the screening visit.","75 Years",{"count":210,"type":21},[55],"Disturbances in brain insulin sensitivity are associated not only with obesity and type 2 diabetes, but also with brain aging and cognitive decline. Longitudinal studies suggest that dietary patterns, particularly those high in dairy intake, may impact brain function via the gut-brain axis. Indeed, dairy foods are known to modulate gut microbiota and may, through this pathway, not only improve brain insulin sensitivity and cognitive performance, but also mental health and appetite regulation. However, underlying mechanisms remain largely unexplored. The primary objective of this study is to evaluate, in older adults with overweight or obesity, the effects of a high-dairy food pattern (4-5 daily servings of (butter)milk, cheese, yogurt, or cottage cheese) compared to a low-dairy food pattern (≤1 serving daily) on (regional) brain vascular function and insulin sensitivity. These outcomes will be quantified using the non-invasive MRI perfusion technique Arterial Spin Labeling (ASL), which assesses cerebral blood flow (CBF) in response to intranasal insulin, a validated physiological marker of brain insulin sensitivity. Secondary objectives include changes in cognitive performance (via the CANTAB neuropsychological test battery), gut microbiota composition (via shotgun metagenomic analysis of fecal samples), and appetite-related brain reward activity (via BOLD-fMRI with food cues). Exploratory analyses include conventional cardiometabolic risk markers (blood pressure, lipid and glucose metabolism), and perceivable (consumer) benefits.",[483,484,485,486,487,28],"Brain Insulin Sensitivity","Brain Vascular Function","Cerebral Blood Flow","Cognitive Performance","Appetite Control","2026-01-12",{"date":490,"type":33},"2026-01-21",{"date":492,"type":21},"2025-12-22",{"date":494,"type":21},"2027-04-01",{"name":496,"class":40},"Maastricht University Medical Center",{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":504,"enrollmentInfo":505,"targetDuration":507,"studyType":23,"phases":4,"briefSummary":508,"conditions":509,"keywords":513,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":526,"locationsCount":529},"100619284","smash-study-to-evaluate-the-clinical-efficacy-of-an-extensively-hydrolysed-infant-formula-with-synbiotics-and-a-human-milk-oligosaccharide-hmo-in-infants-with-cows-milk-protein-allergy-cmpa-100619284","NCT07342621","SMASH: Study to Evaluate the Clinical Efficacy of an Extensively Hydrolysed Infant Formula With Synbiotics and a Human Milk Oligosaccharide (HMO) in Infants With Cow's Milk Protein Allergy (CMPA)","SMASH","Inclusion Criteria:\n\n* Infants under 10 months of age at study start (Visit 1).\n* Suspected or recently confirmed cow's milk protein allergy (CMPA), as determined by the investigator.\n* Already formula-fed, or parents\u002Flegal guardians have decided to initiate formula feeding.\n* Inclusion in the study coincides with the first prescription of a hypoallergenic formula.\n* Written informed consent obtained from parents or legal guardians in accordance with local regulations.\n\nExclusion Criteria:\n\n* Infants with functional gastrointestinal symptoms in whom atopy or food allergy is not suspected.\n* Infants who have previously used an extensively hydrolyzed formula (EHF), an amino acid-based formula (AAF), a rice hydrolysate formula, or a soy-based formula.\n* Infants who have previously used a partially hydrolyzed formula for the prevention of cow's milk protein allergy (CMPA).\n* Infants for whom an amino acid-based formula (AAF) is more appropriate as first-line management, including severe forms of CMPA.\n* Contraindications to the use of synbiotics (e.g., preterm infants \\\u003C40 weeks of corrected gestational age at study start, immunodeficiency, short bowel syndrome, parenteral nutrition, post-pyloric feeding, central venous catheter, oncology treatment, or graft-versus-host disease).\n* Any other condition, as assessed by the investigator, that contraindicates the use of an extensively hydrolyzed formula.\n* Any other circumstance, as assessed by the investigator, indicating that the parents or legal guardians are not capable of complying with the study procedures.","10 Months",{"count":506,"type":21},41,"4 Weeks","Cow's milk protein allergy (CMPA) is one of the most common food allergies in infants, with an estimated prevalence between 2% and 5%. The number of diagnosed cases has increased in recent years, with clinical manifestations involving the gastrointestinal tract, respiratory system, skin, or systemic reactions. Dietary elimination of cow's milk protein remains the mainstay of treatment, using extensively hydrolyzed formulas (EHF) or amino acid-based formulas (AAF), depending on the severity of the allergy.\n\nThis study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed whey-based formula (Almirón Pepti Syneo®) containing a symbiotic mixture (scGOS\u002FlcFOS 9:1 and Bifidobacterium breve M-16V), the human milk oligosaccharide 2'-fucosyllactose (2'-FL), and a reduced amount of purified lactose, in infants with suspected or confirmed CMPA in a real-world clinical practice setting.\n\nThis is a prospective, longitudinal, open-label, single-arm, multicenter study including approximately 41 infants under 10 months of age at several primary care centers and one hospital in Valencia, Spain. Each participant will be followed for four weeks. A subgroup of participants will also provide stool samples to explore the effect of the study formula on gut microbiota composition.",[510,511,512,28],"Cow's Milk Protein Allergy (CMPA)","Food Hypersensitivity","Infant Nutrition Disorders",[514,515,516,517,518,519],"Extensively Hydrolyzed Formula","Synbiotics","Cow's Milk Protein Allergy","Real World Evidence","Microbiota","Gastrointestinal Symptoms","2026-01-05",{"date":522,"type":33},"2026-01-15",{"date":524,"type":33},"2025-02-07",{"date":466,"type":21},{"name":527,"class":528},"Outcomes'10","NETWORK",13,{"id":531,"slug":532,"hasResults":12,"nctId":533,"briefTitle":534,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":537,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":538,"conditions":539,"keywords":543,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":41},"100596945","impact-of-transcatheter-aortic-valve-implantation-tavi-on-the-gut-microbiota-in-patients-with-aortic-valve-stenosis-100596945","NCT07052071","Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis","GUT-TAVI","Inclusion Criteria:\n\n* Aortic stenosis suitable for TAVI\n\nExclusion Criteria:\n\nPatients will be excluded if they present any condition or intervention that may independently affect gut microbiota composition. These include:\n\n* Use of antibiotics, systemic corticosteroids, antivirals, probiotics, bile acid sequestrants, or new medications within one month prior to enrollment.\n* History of inflammatory bowel disease.\n* End-stage renal disease requiring dialysis.\n* End-stage chronic liver disease.\n* Acute infection. Patients with aortic stenosis due to rheumatic fever or infectious endocarditis will be excluded.\n* Active cancer under treatment.\n* Psychiatric illness impairing ability to consent.\n* Substance or alcohol abuse.",{"count":210,"type":21},"This study investigates the impact of transcatheter aortic valve implantation (TAVI) on the composition and function of the gut microbiota in patients with severe aortic valve stenosis. The improvement in haemodynamics following TAVI may positively influence gut microbial balance by increasing splanchnic perfusion and reducing intestinal congestion. A total of 40 patients undergoing TAVI at the \"Hippokration\" General Hospital of Athens will be enrolled, with the aim of analysing stool and blood samples before and after the procedure. The primary endpoint is the change in gut microbiota composition two months post-TAVI, assessed via 16S rRNA sequencing. Secondary endpoints include changes in serum TMAO levels and their association with the severity of aortic stenosis and post-procedural valve haemodynamics. Data will be collected at two timepoints (1 month up to 1 day pre-TAVI and 3 to 4 months post-TAVI), along with dietary questionnaires to account for potential confounding factors. This observational study aims to highlight the potential relationship between cardiac function and the gut microbiome, offering new perspectives for targeted therapeutic strategies in cardiovascular disease.",[540,184,28,541,542],"Aortic Stenosis","TAVI","TAVI(Transcatheter Aortic Valve Implantation)",[541],"2025-11-14",{"date":546,"type":33},"2025-11-18",{"date":548,"type":33},"2025-09-01",{"date":550,"type":21},"2027-11-01",{"name":552,"class":40},"Hippocration General Hospital",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":107,"sex":17,"minAge":271,"maxAge":478,"enrollmentInfo":560,"targetDuration":4,"studyType":53,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":568,"lastUpdatePostDateStruct":569,"startDateStruct":571,"completionDateStruct":573,"leadSponsor":575,"locationsCount":41},"100609883","gut-mini-pill-study-100609883","NCT07220369","Gut Mini-Pill Study","Evaluation of Ingestible Mini-pill for Gastrointestinal Regional Luminal Content Sampling","Inclusion Criteria:\n\n* Men and postmenopausal women\n* Age \\>50 to \\\u003C75 years\n* BMI \\>20 to \\\u003C35 kg\u002Fm2\n* Normotensive with or without medication\n* Normal gastrointestinal function with regular bowel movements at least once every other day\n* Normal kidney and liver function\n* Willingness to swallow the mini-pills\n* Willingness to collect and return multiple stool samples\n* Adequate refrigerator and freezer space to store study entrées\n* Intent to remain in the greater Boston area during the intervention periods\n\nExclusion Criteria:\n\n* Individuals self-reporting adhering to any type of vegetarian diet\n* Lack of willingness to restrict fish intake to less than once per week during the dietary intervention phases\n* Allergy\u002Fintolerance\u002Freligious reasons to avoid study foods or food ingredients, including known hypersensitivity to Blue 1 food coloring and wheat gluten.\n* Regular use of prebiotics or probiotics within the past 3 months\n* Regular use of laxatives or fiber supplements\n* Chronic constipation\n* Chronic use of antibiotics (except topical)\n* Regular use of stomach acid lowering and weight loss medications such as GLP-1 agonists\n* Use of dental prophylaxis\n* Planned colonoscopy 2 months prior to or during the study period\n* Gastroparesis\n* Swallowing disorder, or inability or difficulty taking pills\n* Malabsorptive and inflammatory bowel disease, diverticulosis, and history of diverticulitis, gastric\u002F esophageal\u002Fintestinal surgery, including lap banding or bariatric surgery.\n* History of bowel obstruction, pancreas and liver disorders.\n* Any form of active substance abuse or dependence (including drug or alcohol abuse). This information will be stored in REDCAP in a subsection that has no identifiers.\n* Established major chronic diseases such as cardiovascular disease, diabetes, active cancer within the last 5 years, or any significant medical condition at the study MD's discretion\n* A clinical condition that, in the judgment of the study MD or principal investigator, could potentially pose a health risk to the subject while involved in the study.\n* Unwillingness to adhere to study protocol\n* Intent to increase or decrease body weight during the study period\n* No Social Security number (for payment and IRS forms).\n* Individuals who directly report to any member of the research team.",{"count":5,"type":21},[55],"The purpose of this proof-of-concept study in humans is to determine if a noninvasive, ingestible device, called a \"mini-pill\", can collect gastrointestinal (GI) luminal content samples from 2 different locations along the GI tract after consumption of diets differing in protein source (meat and plant-based meat alternatives). The mini-pills will be recovered in the stool. We will analyze the microbial profile of the mini-pill contents and in stool, and also measure blood biomarkers related to cardiometabolic risk, to better understand the relationship between diet, microbiota and health.",[28],[565,566,567,131],"gut","mini-pill","gut sampling","2025-10-28",{"date":570,"type":33},"2025-10-30",{"date":572,"type":33},"2025-09-08",{"date":574,"type":21},"2028-08",{"name":576,"class":40},"Tufts University",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":107,"sex":17,"minAge":585,"maxAge":586,"enrollmentInfo":587,"targetDuration":4,"studyType":53,"phases":589,"briefSummary":590,"conditions":591,"keywords":595,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":608},"100608865","effect-of-follow-on-formula-on-the-gut-microbiota-of-healthy-infants-100608865","NCT07207109","Effect of follow-on Formula on the Gut Microbiota of Healthy Infants.","A Double-blind Randomised Controlled Study to Investigate the Effect of a follow-on Formula With a Specific Synbiotic Mixture on the Gut Microbiota Composition in Healthy Infants.","FUNTASTIC","Inclusion Criteria:\n\n1. Healthy infants as per the clinical judgement of the Investigator\n2. Singleton infants\n3. Infants ≥6 months and ≤9 months of age at Visit 1\n4. Infant's weight-for-age WHO z-score within ± 2 SD at Visit 1\n5. Infants fed with an infant or follow-on formula at Visit 1.\n6. Infants are familiar with, and are expected to drink, ≥600 mL formula per day.\n7. Written informed consent (IC) from parent(s) and\u002For legally acceptable representative(s) aged ≥18 years at Visit 1.\n\nExclusion Criteria:\n\n1. Infants with known or suspected medical conditions requiring a special diet or special formulae, food allergy, or food intolerances\n2. Infants who received breastfeeding ≤14 days before Visit 1\n3. Infants who are potty-trained\n4. Infants with current or previous illnesses\u002Fconditions and\u002For known or suspected congenital diseases or malformations which could interfere with the study outcomes, as per investigator's clinical judgement.\n5. Use of medication or nutritional products\u002Ffood supplements known to impact the study outcomes ≤14 days before Visit 1 or expected need during the study.\n6. Infants with previous, current, or intended participation in any other clinical study involving investigational or marketed products.\n7. Incapability of infants' parents and\u002For legally acceptable representative(s) to comply with study protocol as per the judgement of the investigator or investigator's uncertainty about the willingness or ability of parents legally acceptable representative(s) to comply with the protocol requirements, including access to a phone.\n8. Children of employees and\u002For family members or relatives of employees of Danone, the participating sites, or any other nutrition company that develops infant, follow-on or young child formulae.","6 Months","9 Months",{"count":588,"type":21},268,[55],"This study investigates the effects of follow-on formula in infants aged 6-9 months over a 12-week period. After parents give consent, their baby's feeding habits, stool characteristics, and any illnesses or medication use will be recorded. Infants will be randomly assigned to receive either the test or control product. Growth and health data will be collected during study visits.\n\nParents will collect stool samples and complete diaries to help researchers better understand the baby's digestion and overall health. A follow-up phone call will be made to check on the baby's well-being after the study ends.",[592,593,594,28],"Follow-on Formula","Infant","Faeces",[596,597,131],"Follow-on formula","healthy infants","2025-10-02",{"date":600,"type":33},"2025-10-03",{"date":602,"type":21},"2025-11",{"date":604,"type":21},"2027-06",{"name":606,"class":607},"Nutricia Research","INDUSTRY",2,{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":615,"eligibilityCriteria":616,"healthyVolunteers":107,"sex":108,"minAge":177,"maxAge":150,"enrollmentInfo":617,"targetDuration":4,"studyType":53,"phases":618,"briefSummary":619,"conditions":620,"keywords":626,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":41},"100569196","how-a-single-workout-affects-gut-bugs-in-women-with-different-fitness-levels-and-body-types-100569196","NCT06691100","How a Single Workout Affects Gut Bugs in Women With Different Fitness Levels and Body Types","The Acute Effects of an Endurance Exercise Bout the Gut Microbiome and Gut-derived Metabolome in Women's Distinct Fitness and Body Mass Indexes","FITGut-W","Inclusion Criteria:\n\n* Biological sex: female\n* BMI 19 to 24.99 kg\u002Fm2 or BMI 30-40 kg\u002Fm2\n* Exercisers: Exercise at least 4 times per week for 60 minutes (a total of 240 minutes per week) on a programmed exercise training either on endurance sports (e.g., running, cycling, triathlon), strength (e.g., powerlifting), or team sports (e.g., rugby, football, soccer)\n* Non-Exercisers: Sedentary individuals who have not reached the PA guidelines (150 minutes of moderate-intensity physical activity a week, 75 minutes of vigorous-intensity physical activity, or an equivalent combination of moderate and vigorous-intensity physical activity).\n\nExclusion Criteria:\n\n* Biological sex: male\n* BMI \\\u003C 19 kg\u002Fm2 or \\> 40 kg\u002Fm2\n* Currently pregnant, \\\u003C 2 years postpartum, lactating\n* Currently taking any herbal, fiber, or prebiotic supplement\n* Current or 1-month before the study, taking oral or vaginal antibiotics\n* Diagnosed with any gastrointestinal, endocrine, digestive, cancer, or cardiovascular disease.",{"count":210,"type":21},[55],"This study aims to elucidate the differences in the gut microbiome functional activity and metabolome in adult premenopausal women with distinctive fitness levels and BMIs (with obesity, w\u002Fo obesity). The specific aims are as follows:\n\n* Aim 1: To examine the effects of acute aerobic exercise at 60-70% heart rate reserve (HRRmax) for 30 minutes bout on changes in the abundance of SCFA-producing bacteria and their functional downstream metabolic activity.\n* Aim 2: To examine the effects of acute aerobic exercise at 60-70% HRRmax 30-minute bout on changes in GM-released SCFA concentrations in stool and plasmatic metabolome.",[621,622,623,624,184,406,625,28],"Weight Management","Obesity","Exercise","Women","Health",[28,627,623,621,622],"Womens Health","2025-07-22",{"date":630,"type":33},"2025-07-24",{"date":632,"type":33},"2024-10-16",{"date":634,"type":21},"2027-10-16",{"name":636,"class":40},"George Washington University",{"id":638,"slug":639,"hasResults":12,"nctId":640,"briefTitle":641,"officialTitle":642,"acronym":643,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":17,"minAge":645,"maxAge":586,"enrollmentInfo":646,"targetDuration":4,"studyType":53,"phases":647,"briefSummary":648,"conditions":649,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":41},"100594269","effect-of-a-dietary-supplement-vs-low-dosage-product-on-infant-gastrointestinal-discomfort-and-colics-100594269","NCT07017244","Effect of a Dietary Supplement vs Low-dosage Product on Infant Gastrointestinal Discomfort and Colics","Randomized Double-blind Monocentric Clinical Trial on the Effect of a Dietary Supplement vs Low-dosage Product on Reduction of Infant Gastrointestinal Discomfort and Colics","DISIC","Inclusion Criteria:\n\n* Children Age: 0-9 months Infant colics diagnosed with FLACC (Face, Legs, Activity, Cry, Consolability - preverbal patient pain scale) and G4 Infant Colic Rome IV criteria\n\nExclusion Criteria:\n\n* infants suffering from acute or chronic diseases, such as chronic lung disease; diarrhea underlying specific diseases or developmental disorders confirmed by a pediatrician\n* infants participating in other clinical studies\n* age ≥ 9 months\n* neurological diseases\n* suspected or confirmed food allergy to the ingredients of the products under study\n* gastroesophageal reflux disease\n* use of antibiotics 1-2 weeks before enrolment\n* use of gastric acidity inhibitors at any time before enrolment\n* fever and\u002For infectious diseases at any time before enrolment\n* current systemic infections\n* history of congenital infections","0 Months",{"count":82,"type":21},[55],"The goal of this clinical trial is to verify whether a food supplement is effective in treating infantile colic of infants aged between 21 days and 9 months and the colonization ability of the gut microbiota by measuring faecal relative abundance of the gut microbiota probiotic treatment species.\n\nThe main outcomes are: - the mean number of crying episodes and the sleep duration - Relative abundance of the gut microbiota probiotic treatment species.",[650,28],"Infant Colic","2025-06-11",{"date":653,"type":33},"2025-06-12",{"date":655,"type":21},"2025-06-15",{"date":657,"type":21},"2025-12-15",{"name":659,"class":40},"Azienda Ospedaliera Universitaria Policlinico \"G. Martino\"",{"id":661,"slug":662,"hasResults":12,"nctId":663,"briefTitle":664,"officialTitle":665,"acronym":4,"eligibilityCriteria":666,"healthyVolunteers":107,"sex":108,"minAge":18,"maxAge":667,"enrollmentInfo":668,"targetDuration":4,"studyType":53,"phases":670,"briefSummary":671,"conditions":672,"keywords":677,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":687,"locationsCount":41},"100505513","the-maternal-eed-study-100505513","NCT05862363","The Maternal EED Study","Small Intestinal Microbiota of Low Body Mass Index (BMI) & Normal BMI Women of Reproductive Age and Microbiota-directed Balanced Energy Protein (MD-BEP) Supplementation in Maternal Environmental Enteric Dysfunction (EED)","Inclusion Criteria:\n\nInclusion criteria for pregnant low-BMI women\n\n1. Bangladeshi female, age 18-35 years\n2. BMI 20-24.9 kg\u002Fm2\n3. Middle-upper socioeconomic class (≥ $11\u002Fday family income)\n4. Functional dyspepsia\n5. Willing to sign the consent form\n6. Willing to provide biological samples during the study period of 6 months\n\nInclusion criteria for non-pregnant low-BMI women 1. Bangladeshi female, age 18-35 years\n\n1. BMI \\\u003C18.5 kg\u002Fm2\n2. No antibiotics for 1 month\n3. Willing to sign the consent form\n4. Willing to undergo endoscopy and biopsy\n5. Willing to provide biological samples during the study period of 6 months\n6. Willing to receive food supplementation for 3 months\n\nInclusion criteria for normal-BMI non-pregnant women\n\n1. Bangladeshi female, age 18-35 years\n2. BMI 20-24.9 kg\u002Fm2\n3. Middle-upper socioeconomic class (≥ $11\u002Fday family income)\n4. Functional dyspepsia\n5. Willing to sign the consent form\n6. Willing to provide biological samples during the study period of 6 months\n\nInclusion criteria for normal-BMI pregnant women\n\n1. Bangladeshi female, age 18-35 years\n2. BMI 20-24.9 kg\u002Fm2\n3. Middle-upper socio-economic class (≥ $11\u002Fday family income)\n4. Enrolled at the end of first-trimester of pregnancy (before 14 weeks of gestation)\n5. Willing to sign the consent form\n6. Willing to undergo endoscopy and biopsy\n7. Willing to provide biological samples during the study period\n8. Willing to let anthropometry and biological sample collection from her newborn for the first 6 months of life\n\nExclusion Criteria:\n\nExclusion criteria for pregnant low-BMI women\n\n1. Received antibiotics during the last one month\n2. Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity\n3. Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days\n\nExclusion criteria for non-pregnant low-BMI women\n\n1. Severe anemia (\\\u003C8 g\u002Fdl), TB and other chronic diseases, including diabetes mellitus, urogenital infections or any congenital disorder or deformity\n2. Pregnancy, lactation, drug abuse, known psychiatric disorders\n3. High clinical suspicion of cancer or other chronic or acute diseases that may cause malnutrition. Adult participants who fulfill the inclusion criteria and are not excluded through history and clinical examination will undergo following screening tests based on clinical judgement:\n\n   1. Chest x-ray\n   2. Urine for R\u002FE\n   3. Ultrasonography of whole abdomen\n   4. Fasting blood glucose\u002F HbA1c\n   5. Stool for OBT (occult blood test)\n   6. Cancer markers (ie. CEA, CA 15.3, CA 19.9)\n4. Known allergy to any components of nutrition intervention\n5. Nugent Score\u002FAmsel Criteria to exclude bacterial vaginosis: A Nugent score 3-4 is consistent with Bacterial vaginosis (BV). The modified Amsel criteria with a cut-off value of 2 (pH+VD; sensitivity 71%, specificity 90%, accuracy 88% or KOH+VD; sensitivity 75%, specificity 91%, accuracy 89%) might be considered for this purpose20.\n6. Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days\n\nExclusion criteria for non-pregnant normal-BMI women\n\n1. Received antibiotics during the last one month\n2. Presence of any chronic disease including diabetes mellitus or any congenital disorder or deformity\n3. Ongoing episode of diarrhea, history of persistent diarrhea in the past month or history of acute diarrhea in the past 7 days\n\nExclusion criteria for pregnant normal-BMI women\n\n1. Multiple pregnancy (carrying two or more fetuses)\n2. Threatened abortion, persistent pervaginal bleeding, or cervical incompetence\n3. History of three or more consecutive abortions\n4. History of gestational diabetes, macrosomia, gestational hypertension, preeclampsia\u002Feclampsia in a prior pregnancy\n5. Active disease\u002Fcomplications requiring acute phase treatment in a hospital\n6. Tuberculosis\n7. Severe anemia (Hb concentration \\\u003C 8 mg\u002Fdl)\n8. Antibiotic use (ongoing or within last two weeks before the onset of intervention)\n9. Taking medications such as insulin, thyroid hormones, glucocorticoids\n10. Chronic diseases, such as hypertension, heart disease, chronic obstructive pulmonary disease, chronic kidney disease, chronic liver disease, pancreatic diseases, Crohn's disease, ulcerative colitis, diabetes mellitus, thyroid dysfunction, immunological diseases, malignancy, or any congenital disorder or other diseases which could impede compliance with the study protocol\n11. Known case of serious psychiatric or behavioral disorders, such as schizophrenia, bipolar disorder\n12. Having known history of allergy to the therapeutic agents\n13. Having a plan to move or deliver outside the study area\n14. Known allergy to any components of nutrition intervention.","35 Years",{"count":669,"type":21},180,[55],"Undernutrition among women of reproductive age is more common in South Asia than in any other region. In South Asia, the prevalence of maternal undernutrition varies between 10 and 40%. There is a scarcity of data on the contribution of small intestinal (SI) microbiota to pathogenesis of Environmental Enteric Dysfunction (EED) of malnutrition, as it is difficult to obtain gut biopsy specimens from malnourished individuals, especially children. The Bangladesh Environmental Enteric Dysfunction (BEED) study, involving participants who live in an urban slum (Mirpur) in Dhaka, provided an opportunity to examine the role of the duodenal microbiota in the pathogenesis of EED in children and also performed esophagogastroduodenoscopy (EGD) on thirty-eight 18-45-year-old malnourished (BMI\\\u003C18.5 kg\u002Fm2) women residing in the same resource-poor setting of Mirpur, Dhaka who failed to respond to an egg\u002Fmilk\u002Fmicronutrients- based nutritional intervention comparable to that given to children. In this intervention component, beginning at the end of the first trimester, low-BMI (\\\u003C18.5 kg\u002Fm2) pregnant women (aged 18-35 years) will be randomly assigned to receive either Microbiota-directed Balanced Energy Protein (MD-BEP) or Ready-to-Use-Supplementary Food Balanced Energy Protein (RUSF-BEP) for the duration of their pregnancy and during the first 3 postnatal months, in addition to standard antenatal care. A parallel cohort of age-matched normal-BMI pregnant women who will not receive any nutritional intervention will serve as a reference control group.",[673,674,675,28,676],"Environmental Enteric Dysfunction (EED)","Malnutrition","Women of Reproductive Age","Balanced Energy Protein (BEP)",[678,679,63,674,680],"Balanced energy protein (BEP)","Environmental enteric dysfunction (EED)","Women of reproductive age","2025-05-12",{"date":683,"type":33},"2025-05-14",{"date":685,"type":33},"2023-01-02",{"date":97,"type":21},{"name":688,"class":40},"International Centre for Diarrhoeal Disease Research, Bangladesh",{"id":690,"slug":691,"hasResults":12,"nctId":692,"briefTitle":693,"officialTitle":694,"acronym":4,"eligibilityCriteria":695,"healthyVolunteers":107,"sex":17,"minAge":696,"maxAge":270,"enrollmentInfo":697,"targetDuration":698,"studyType":23,"phases":4,"briefSummary":699,"conditions":700,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":702,"lastUpdatePostDateStruct":703,"startDateStruct":705,"completionDateStruct":707,"leadSponsor":709,"locationsCount":41},"100528175","characteristics-of-intestinal-bacteria-and-their-effects-on-growth-and-immune-function-in-children-at-high-altitude-100528175","NCT06157346","Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude","Characteristics of Intestinal Bacteria and Their Effects on Growth and Immune Function in Children at High Altitude in Diqing Tibetan Autonomous Prefecture, Yunnan Province","Inclusion Criteria:\n\n* Children aged 1-3 years old\n* Both men and women;\n* The child's legal guardian signed the informed consent to participate in the study.\n* The legal guardian of the child commits to follow the study procedures and cooperate with the entire study process\n\nExclusion Criteria:\n\n* Probiotics or antibiotics within 1 month\n* Associated with clinically significant abnormalities in liver and kidney function, nervous system, respiratory system, and coagulation function as determined by the investigator\n* Unstable vital signs;\n* Have other underlying medical conditions\n* Individuals deemed unsuitable for this clinical trial.","1 Year",{"count":428,"type":21},"7 Days","Microbes and the human body maintain a complex relationship of interaction and influence. Different regions, altitudes, and dietary habits have different degrees of influence on the composition of children's intestinal flora. Therefore, the development and maturation process of children's intestinal flora in plateau areas was discovered, and its relationship with children's immunity, metabolism, and growth was understood. The mechanism of action of children's intestinal flora on immunity, growth and development was further analyzed by comparing it with people in low-altitude areas, to provide a scientific basis for improving children's health in plateau areas.",[625,701,28],"Children, Only","2025-04-03",{"date":704,"type":33},"2025-04-04",{"date":706,"type":33},"2023-10-16",{"date":708,"type":21},"2026-08-31",{"name":710,"class":40},"Ruijin Hospital",{"id":712,"slug":713,"hasResults":12,"nctId":714,"briefTitle":715,"officialTitle":715,"acronym":4,"eligibilityCriteria":716,"healthyVolunteers":12,"sex":17,"minAge":208,"maxAge":4,"enrollmentInfo":717,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":718,"conditions":719,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":721,"lastUpdatePostDateStruct":722,"startDateStruct":724,"completionDateStruct":726,"leadSponsor":728,"locationsCount":41},"100555540","gut-microbiota-and-pulmonary-complications-after-non-cardiac-elective-surgery-in-elderly-patients-100555540","NCT06513416","Gut Microbiota and Pulmonary Complications After Non Cardiac Elective Surgery in Elderly Patients","Inclusion Criteria:\n\n1. Age: ≥ 65 years old;\n2. Surgery: Upper abdominal surgery (expected duration ≥ 2 hours);\n3. Anesthesia methods: general anesthesia, tracheal intubation;\n4. ASA classification: I-IV levels;\n5. Postoperative Pulmonary Complications Risk Score (ARISCAT): Medium to High Risk\n6. Patients or their families are able to understand the research protocol and are willing to participate in this study, providing written informed consent\n\nExclusion Criteria:\n\n1. Emergency surgery;\n2. This is the second surgery within the past month;\n3. Preoperative presence of pulmonary infection or other serious pulmonary complications\n4. Patients who have used antibiotics, probiotics, and acid suppressants within one month before surgery",{"count":451,"type":21},"This study adopts a combination of retrospective and prospective cohort research methods to explore the composition of preoperative oropharyngeal and gut microbiota in elderly patients undergoing elective upper abdominal surgery, aiming to analyze the correlation between preoperative oropharyngeal and intestinal microbiota composition and metabolite levels and the occurrence of postoperative pulmonary complications (PPCs). The research subjects of the retrospective cohort study were participants (ClinicalTrials.gov No. NCT05679661) included in the prospective RCT on the effects of perioperative immune nutrition intervention and oral hygiene on postoperative complications in elderly patients, which was conducted at Peking Union Medical College Hospital from January 2023 to present. The prospective cohort study plans to continue enrolling elderly patients aged ≥ 65 who underwent elective upper abdominal surgery.\n\nThis study collects preoperative oropharyngeal and fecal samples, as well as preoperative plasma from patients for microbial sequencing and untargeted metabolomics analysis. The main outcome measurement is PPCs, which include pneumonia, atelectasis, and hypoxemia within 7 days after surgery. Inflammatory cells and cytokines in peripheral blood are secondary outcomes.",[28,720],"Postoperative Pulmonary Complications","2025-02-26",{"date":723,"type":33},"2025-02-28",{"date":725,"type":33},"2023-02-01",{"date":727,"type":21},"2025-12-31",{"name":729,"class":40},"Peking Union Medical College Hospital"]