[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ENBIOSIS BIOTECHNOLOGIES\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100643182","aim-met-ai-guided-microbiome-targeted-nutrition-for-glycemic-improvement-in-type-2-diabetes-100643182",false,"NCT07622628","AIM-MET: AI-Guided Microbiome-Targeted Nutrition for Glycemic Improvement in Type 2 Diabetes","A 24-Week Randomized, Masked, Placebo-Controlled Trial of an AI-Guided Microbiome-Targeted Nutritional Intervention for Glycemic Improvement in Adults With Type 2 Diabetes: The AIM-MET Trial","AIM-MET","Inclusion Criteria:\n\nAdults aged 18 to 65 years.\n\nEstablished diagnosis of type 2 diabetes mellitus documented in the medical record, supported by American Diabetes Association diagnostic criteria on at least one prior occasion.\n\nHbA1c 6.8% to 8.2% at screening, measured by an NGSP-certified central laboratory assay; confirmed on a repeat sample if discordant with prior records or if the screening value is at the upper or lower boundary.\n\nBody mass index 18.5 to 40.0 kg\u002Fm2 at screening.\n\nStable background glucose-lowering therapy for at least 3 months before randomization, restricted to metformin, a DPP-4 inhibitor, and\u002For an SGLT2 inhibitor, either alone or in combination.\n\nDocumented body-weight stability, defined as no more than +\u002F-5% or +\u002F-3 kg, whichever is smaller, self-reported body-weight change during the 3 months before screening.\n\nWilling and able to provide written informed consent.\n\nWilling and able to comply with trial visits, study product use, fasting blood sampling, stool sampling, and the study assessment schedule.\n\nWilling to receive standardized lifestyle counselling during the 24-week blinded period and to maintain stable background diabetes management as clinically directed.\n\nNo systemic antibiotic use within 8 weeks before randomization.\n\nNo probiotic, prebiotic, synbiotic, or postbiotic supplement use within 8 weeks before randomization.\n\nStable hypertension, dyslipidaemia, and stable thyroid replacement therapy are permitted if medication has been initiated and the dose unchanged for at least 3 months before randomization.\n\nExclusion Criteria:\n\nType 1 diabetes, latent autoimmune diabetes of adults, pancreatogenic diabetes, maturity-onset diabetes of the young, gestational diabetes as the current diagnosis, or any non-type-2 form of diabetes.\n\nHbA1c less than 6.8% or greater than 8.2% at screening.\n\nCurrent use of GLP-1 receptor agonists or GLP-1\u002FGIP co-agonists, or use within 12 months before randomization.\n\nCurrent use of basal, prandial, or premixed insulin, or any insulin use within 6 months before randomization.\n\nCurrent use of sulfonylureas or meglitinides, or use within 3 months before randomization.\n\nCurrent use of anti-obesity pharmacotherapy or use within 6 months before randomization, including orlistat, naltrexone\u002Fbupropion, phentermine\u002Ftopiramate, or other agents with a primary anti-obesity indication.\n\nRecurrent severe hypoglycaemia or hypoglycaemia unawareness.\n\nPlanned initiation or dose escalation of glucose-lowering medication, anti-obesity medication, or systemic corticosteroids during the 24-week trial period in the judgment of the treating clinician.\n\nHistory of bariatric surgery at any time.\n\nGastrointestinal surgery other than appendectomy or uncomplicated cholecystectomy.\n\nActive inflammatory bowel disease, coeliac disease, microscopic colitis, chronic pancreatitis, malabsorption syndrome, or chronic severe gastrointestinal disease likely to affect absorption or trial adherence.\n\nAcute gastroenteritis within 4 weeks before randomization.\n\nColonoscopy bowel preparation within 12 weeks before randomization.\n\nFaecal microbiota transplantation within 12 months before randomization.\n\nActive or recent malignancy within 6 months, except adequately treated non-melanoma skin cancer.\n\nStage 3b to 5 chronic kidney disease, defined as estimated glomerular filtration rate less than 45 mL\u002Fmin\u002F1.73 m2.\n\nDecompensated liver disease or Child-Pugh class B\u002FC.\n\nALT or AST greater than 3 times the upper limit of normal at screening, unless judged clinically insignificant and approved by the investigator.\n\nKnown or suspected haemoglobinopathy that materially distorts HbA1c measurement or haemoglobin variant known to interfere with the central laboratory assay.\n\nBlood transfusion, significant blood loss greater than 250 mL, or erythropoiesis-stimulating agent therapy within 3 months before randomization.\n\nUntreated overt thyroid disease, or thyroid medication initiation or dose change within 3 months before randomization.\n\nUse of systemic corticosteroids within 4 weeks before randomization.\n\nUse of immunosuppressive medication or biologic\u002Fimmunomodulatory therapy within 5 half-lives before randomization.\n\nPregnancy or lactation; women of childbearing potential not willing to use effective contraception during the 24-week blinded period.\n\nSevere psychiatric illness or cognitive impairment that may compromise informed consent, safety, or adherence.\n\nActive eating disorder, defined operationally as a positive SCOFF screen with at least 2 affirmative responses at screening, or clinical diagnosis of anorexia nervosa, bulimia nervosa, or binge-eating disorder.\n\nHeavy alcohol use or active substance use disorder.\n\nCurrent very-low-calorie diet, ketogenic diet, medically supervised weight-loss diet, or other highly restrictive diet that excludes major food groups.\n\nCurrent cigarette smoking with intention to attempt cessation during the 24-week trial period; current users of nicotine-replacement or smoking-cessation pharmacotherapy initiated within 3 months before randomization.\n\nParticipation in another interventional clinical trial within 30 days before screening.\n\nKnown hypersensitivity or clinically significant intolerance to any component of the active product or placebo.\n\nInability or unwillingness to provide stool samples.\n\nAny condition that, in the investigator's opinion, would compromise participant safety or trial integrity.","ALL","18 Years","65 Years",{"count":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"NA","AIM-MET is a randomized clinical study testing whether a fixed microbiome-targeted nutritional product can improve blood sugar control in adults with type 2 diabetes when used in addition to usual stable diabetes treatment.\n\nThe study will compare the active nutritional product with a matching placebo over 24 weeks. The product was designed using artificial intelligence before the study began, but the same fixed formulation will be used for all participants assigned to the active group. Artificial intelligence will not be used during the study to make individual treatment decisions, adjust dosing, or personalize the product.\n\nThe main question is whether participants receiving the active product have a greater reduction in HbA1c, a standard marker of average blood sugar levels, from the start of the study to Week 24 compared with participants receiving placebo. The study will also evaluate early blood sugar changes, fasting glucose, body weight and waist measurements in participants with baseline BMI of at least 25.0 kg\u002Fm2, safety, hypoglycaemia events, patient-reported outcomes, and gut microbiome features.\n\nThis is a 100-participant proof-of-concept study intended to estimate the size of the treatment signal, safety, feasibility, and parameters needed for a future larger confirmatory trial.",[28,29],"Type 2 Diabetes","Diabetes Mellitus Type 2",[31,32,33,34,35,36,37,38,39,40,41,15],"Type 2 diabetes","Type 2 diabetes mellitus","HbA1c","Glycemic response","Glycemic control","Microbiome","Gut microbiome","Nutritional intervention","AI-guided formulation design","Artificial intelligence","Randomized controlled trial","RECRUITING","2026-06-05",{"date":45,"type":46},"2026-06-09","ACTUAL",{"date":48,"type":22},"2026-06-08",{"date":50,"type":22},"2027-06-30",{"name":52,"class":53},"ENBIOSIS BIOTECHNOLOGIES","INDUSTRY",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":54},"100643523","aim-ibd-a-microbiome-targeted-supplement-in-mild-to-moderate-ulcerative-colitis-100643523","NCT07619638","AIM-IBD: A Microbiome-Targeted Supplement in Mild-to-Moderate Ulcerative Colitis","AIM-IBD: A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial of a Microbiome-Targeted Food Supplement Versus Placebo in Adults With Mild-to-Moderate, Objectively Active Ulcerative Colitis","AIM-IBD","Inclusion Criteria:\n\n1. Adults aged 18 to 75 years inclusive at screening.\n2. Documented diagnosis of ulcerative colitis established at least 3 months before screening, based on standard clinical, endoscopic, and histologic criteria.\n3. Mild-to-moderate active ulcerative colitis defined by a partial Mayo score of 4 to 8 at screening.\n4. Rectal bleeding subscore of at least 1 at screening.\n5. Objective intestinal inflammation defined by fecal calprotectin of at least 250 micrograms per gram at screening, measured by the central laboratory or by a validated harmonized assay.\n6. Eligible disease extent: left-sided colitis or extensive\u002Fpancolitis. Proctosigmoiditis is eligible if inflammation extends beyond isolated proctitis and is measurable by study endoscopy. Isolated ulcerative proctitis (E1 only) is eligible only within a prespecified cap not exceeding 10 percent of total enrollment.\n7. Either no current ulcerative colitis-directed therapy, or stable oral and\u002For rectal 5-aminosalicylate (5-ASA, mesalamine) therapy at unchanged dose for at least 8 weeks before randomization, with intent to continue at the same unchanged dose through Week 24 unless rescue therapy is clinically required.\n8. Able and willing to provide written informed consent.\n9. Able and willing to comply with study visits, stool sampling, endoscopy, medication restrictions, and diary\u002Fpatient-reported outcome completion.\n10. Participants of childbearing potential must agree to use a highly effective method of contraception during dosing and for at least 4 weeks after the last dose, in accordance with EMA\u002FCTFG guidance and local ethics requirements.\n\nExclusion Criteria:\n\n1. Crohn disease, inflammatory bowel disease-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or any other non-ulcerative-colitis form of colitis.\n2. Severe ulcerative colitis, acute severe ulcerative colitis, fulminant colitis, toxic megacolon, or any disease severity requiring immediate hospitalization or treatment escalation in the investigator's judgment.\n3. Isolated ulcerative proctitis (E1 only) outside the prespecified 10 percent enrollment cap.\n4. Use of biologics, Janus kinase (JAK) inhibitors, sphingosine-1-phosphate (S1P) receptor modulators, or systemic immunosuppressants within 8 weeks before randomization, or planned use of any of these during the trial.\n5. Systemic corticosteroids within 4 weeks before randomization.\n6. Current budesonide-class therapy at baseline.\n7. Rectal or topical corticosteroids unless discontinued at least 2 weeks before randomization.\n8. Antibiotic use within 4 weeks before randomization, except topical antibiotics not expected to affect the gut microbiota.\n9. Probiotic, prebiotic, synbiotic, postbiotic, fermented microbiome-directed supplement, or other non-study microbiome-directed product within 4 weeks before randomization, or planned use during the trial.\n10. Active or recent Clostridioides difficile infection within 12 weeks before screening (screening uses a two-step algorithm: glutamate dehydrogenase plus toxin A\u002FB enzyme immunoassay, with reflex nucleic acid amplification testing for discordant results).\n11. Positive stool test for any clinically relevant enteric infection at screening, per local diagnostic standard operating procedures.\n12. Prior colectomy, planned colectomy, known dysplasia requiring intervention, or colorectal cancer.\n13. Pregnancy, breastfeeding, or planned pregnancy during the trial.\n14. Uncontrolled clinically significant comorbidity, including but not limited to uncontrolled diabetes, advanced liver or renal disease, unstable cardiovascular disease, immunodeficiency, active malignancy other than adequately treated non-melanoma skin cancer, or any other condition compromising participant safety or interpretation of study results.\n15. Known allergy, intolerance, or contraindication to any component of the investigational product or matching placebo.\n16. Participation in another interventional clinical trial within 30 days before screening.\n17. Any other condition that, in the investigator's judgment, would make participation unsafe or compromise protocol adherence.","75 Years",{"count":65,"type":22},162,[25],"This Phase 2b randomized, double-blind, placebo-controlled, multicenter trial will evaluate the efficacy and safety of a once-daily oral microbiome-targeted food supplement compared with matching placebo in adults with mild-to-moderate, objectively active ulcerative colitis. The supplement is food-grade and is intended for use either alongside stable standard ulcerative colitis therapy (5-aminosalicylic acid\u002Fmesalamine) or in participants not currently on any inflammatory bowel disease therapy.\n\nApproximately 162 participants will be enrolled at university hospital centers in Turkey and randomized in a 1:1 ratio to receive either the food supplement or matching placebo for 24 weeks, in addition to their existing background therapy as defined by eligibility.\n\nThe primary objective is to determine whether the supplement increases the proportion of participants achieving composite clinical-plus-biochemical remission at Week 24. This composite endpoint requires absence of rectal bleeding, improvement in stool frequency, fecal calprotectin ≤250 micrograms\u002Fg, and no rescue therapy, prohibited treatment escalation, ulcerative colitis-related hospitalization, colectomy, or discontinuation for lack of efficacy before Week 24.\n\nKey secondary endpoints include endoscopic improvement, deep biochemical remission, change in fecal calprotectin, change in partial Mayo score, corticosteroid-free composite remission, change in quality of life, change in C-reactive protein, time to treatment failure, and safety. Exploratory analyses will assess stool microbiome composition, eukaryotic carriage including Blastocystis, and associations between baseline microbiome features and treatment response.",[69,70,71],"Ulcerative Colitis (UC)","Inflammatory Bowel Disease (IBD)","Colitis",[73,74,36,75,76,40,77,78,79,80,81,82,83],"Ulcerative colitis","Inflammatory bowel disease","Gut microbiota","Fecal calprotectin","Partial Mayo score","5-ASA","Mesalamine","Nutraceutical","Placebo-controlled trial","Blastocystis","Microbiome-targeting nutraceutical",{"date":45,"type":46},{"date":86,"type":22},"2026-06-10",{"date":88,"type":22},"2027-11-30",{"name":52,"class":53},""]