[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-urinary-tract-infections-in-women\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-urinary-tract-infections-in-women":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"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":37,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":59},"100588378","a-trial-of-d-mannose-for-the-prophylaxis-of-recurrent-urinary-tract-infections-100588378",false,"NCT06940622","A Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections","A Randomized Controlled Trial of D-mannose for the Prophylaxis of Recurrent Urinary Tract Infections in Post-menopausal Women","DmannoseRCT","Inclusion Criteria:\n\n* Female, post-menopausal, age ≥ 55 years old\n* Diagnosis of recurrent UTI, defined as ≥ 3 symptomatic culture-proven UTI episodes in 12 months or ≥ 2 in 6 months.\n* Currently free from a UTI determined based on absence of symptoms as determined by the UTI symptom assessment questionnaire79 and negative urine culture (\\\u003C103 colony forming units per ml of urine).\n* Able to attend all follow-up appointments for the study.\n* A negative upper and lower urinary tract evaluation, including pelvic examination for pelvic organ prolapse (less than stage 2), measurement of post-void residual (less than 50 ml), and imaging (renal ultrasound and standing voiding cystourethrogram) to exclude kidney stone, hydronephrosis, reflux, or urethral diverticulum.\n\nExclusion Criteria:\n\n* Current use of D-mannose. Patients willing to stop taking D-mannose will be offered to join the trial after a 4-week wash-out period.\n* Complicated UTIs, including need for catheter drainage or intermittent catheterization, neurogenic bladder, bladder augmentation, or urinary diversion.\n* Ongoing supplement use (Box 1). Patients willing to stop taking the listed supplements will be offered to join the trial after a 4-week wash-out period.\n* Evidence of upper tract infection (pyelonephritis), including temperature higher than 38°C, flank\u002Flumbar pain or tenderness\n* Diagnosis of interstitial cystitis or overactive bladder syndrome\n* Prophylactic antibiotics started in the last 3 months and unwilling to discontinue, or intention to start in the next 12 months\n* Use of Uromune or other vaccine approaches to reduce rUTI\n* Participation in a research study involving an investigational product in the past 12 weeks\n* Receipt of phage treatment\n* History of chronic diarrhea requiring regular therapy\n* Inability to swallow or known history of gastrointestinal malabsorption\n* History of recurrent vaginal yeast infections\n* Systemic disease precluding enrollment in this study (uncontrolled diabetes with HgA1C above 7, ongoing chemotherapy or immunotherapy, renal insufficiency \\[creatinine \\> 1.5 g\u002Fdl\\]), mental or cognitive impairment, weight loss diet requiring excessively large amounts of fluid intake, or other health-related specific diet).\n* Nursing home resident\n* BMI \\>40\n\nBox 1 Supplements to avoid\n\n* Multi-Vitamins and Multi-Mineral capsules\n* Specific Vitamins or Minerals (e.g., Calcium, Citrical, Calcium Gummies, Vitamin A, D, Niacin, Pyridoxine, Selenium, Vitamin E, B6, Iron, Omega 3, D3, Magnesium, B-Complex, Women's Ultra MultiVitamin, GNC B-Complex, B-12, PreserVision Areds2, Vitamins D, B Pollen)\n* Probiotics\n* Cranberry Mannose or Cranberry Extract Weight loss products to avoid\n* Medifast\n* Vitafusion\n* OptiVin Products\n* Appetite Suppressants\n* Keto-Fuel","FEMALE","55 Years","85 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"NA","A randomized, double-blind, placebo-controlled, 12-month study to determine the effectiveness of D-mannose (2g daily) supplementation in rUTI (recurrent urinary tract infection) prevention in post-menopausal women.",[28,29,30,31,32,33,34,35,36],"Recurrent UTIs","Recurrent Urinary Tract Infections","Recurrent Urinary Tract Infections in Women","Recurrent Urinary Tract Infection","Cystitis Recurrent","Cystitis Chronic","UTI","UTI - Urinary Tract Infection","UTI - Lower Urinary Tract Infection",[38,39,40,41,42,43,44,45,46],"D-mannose","dmannose","uti","ruti","recurrent urinary tract infection","urinary tract infection","cystitis","chronic uti","chronic cystitis","RECRUITING","2025-09-18",{"date":50,"type":51},"2025-09-22","ACTUAL",{"date":53,"type":51},"2025-08-01",{"date":55,"type":22},"2030-09-30",{"name":57,"class":58},"University of Texas Southwestern Medical Center","OTHER",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":23,"phases":72,"briefSummary":74,"conditions":75,"keywords":76,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100607151","phase-3-evaluate-the-efficacy-and-safety-of-u101-oral-capsules-in-the-prevention-of-uncomplicated-rutis-in-women-100607151","NCT07184827","Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated rUTIs in Women","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of U101 Oral Capsules in the Prevention of Uncomplicated Recurrent Urinary Tract Infections (rUTIs) in Women","U101","Inclusion Criteria:\n\n1. Provide a signed informed consent form.\n2. Non-pregnant, non-nursing females ≥ 20 and \\\u003C 76 years old.\n3. Having a history of ≥ 2 UTI events during the preceding 6 months or ≥ 3 UTI events during the preceding 12 months (including any UTI event that occurs on the date of ICF signing). At least one of the previous UTI events must have microbiologic evidence (e.g., per the investigator's judgment based on urine culture results).\n4. The last urine culture (including those conducted for suspected UTI event or retest) before the randomization has to be negative.\n5. Having a negative urinalysis result and no symptoms suggestive of a UTI on the day of randomization.\n\nExclusion Criteria:\n\n1. Females who are pregnant, nursing, have a desire for pregnancy or have a positive pregnancy test at screening.\n2. Women of childbearing potential who are unwilling or unable to use an acceptable contraceptive method to avoid pregnancy for the entire study period (use of spermicide is prohibited). Women of childbearing potential are defined as premenopausal females capable of becoming pregnant.\n3. Serum aspartate transaminase (AST), serum alanine transaminase (ALT) and serum total bilirubin \\> 1.5 x upper limit of normal (ULN).\n4. Serum creatinine \\> 1.5 x ULN.\n5. Prothrombin time (PT) or INR \\> 1.2 x ULN.\n6. Platelet counts \\\u003C 100,000\u002FμL.\n7. Serum vitamin D level \\\u003C 11 ng\u002FmL.\n8. HbA1c \\> 8.0%.\n9. Positive test for hepatitis B (both HBsAg and HBeAg), hepatitis C (anti-HCV antibody) or HIV (anti-HIV antibody).\n10. Symptoms suggestive of a systemic inflammatory response (fever \\> 38℃ or WBC count \\> 12,000) at the screening.\n11. A major functional or anatomical abnormality of the urogenital tract (e.g., renal cell carcinoma, outlet obstruction, etc.).\n12. Diagnosis of pelvic organ prolapse ≥ grade 2 (according to pelvic organ prolapse quantification POP-Q classification) without any treatment within 6 months of the screening visit.\n13. Diagnosis of complicated UTIs within 6 months of the screening visit.\n14. Residual urine volume \\> 100 mL within a month of the screening visit.\n15. History of interstitial cystitis, pelvic inflammatory disease, or chronic pelvic pain syndrome.\n16. Having any of the following procedures within a week of the screening: urinary catheterization (e.g., Foley catheter), ureteral stent, percutaneous nephrostomy, or cystostomy.\n17. Intravesical instillation of hyaluronic acid within 6 months of the screening visit.\n18. Treatment with pentosan polysulfate sodium (PPS) within 6 months of the screening visit.\n19. Use of antibiotic prophylaxis for rUTI within a month of the screening visit.\n20. Use of local hormone therapy (cream, gel, insert, ring, or tablets) in urogenital areas within a month of the screening.\n21. Any history of thrombocytopenia, hemophilia, or bladder cancer; history of endoscopy-confirmed gastrointestinal ulcers within 3 years prior to randomization.\n22. Active malignancy (under intensive cancer treatment or considered in progression) or a history of any malignancy involving the pelvic cavity within 5 years prior to randomization, with the exception of adequately treated basal cell carcinoma and cervical cancer in-situ. Subjects in stable condition will be evaluated and discussed individually with the investigator.\n23. Immunocompromised or history of organ transplant.\n24. History of allergies to pentosan polysulfate sodium.\n25. Having planned major surgery within 24 weeks after the study.\n26. Participation in any interventional clinical trial within 30 days of the screening visit.\n27. Other significant medical problem(s) or intercurrent acute illness(es) that in the opinion of the Investigators, would make participation in the study unsafe, complicate the interpretation of study outcome data, or otherwise interfere with achieving the study objective.\n28. Subjects who are illiterate.\n29. Subjects having a family history of macular degeneration or having been diagnosed with macular degeneration (except for those with asymptomatic age-related macular degeneration) .","20 Years","75 Years",{"count":71,"type":22},348,[73],"PHASE3","The goal of this clinical trial is to learn if drug U101 works to prevent recurrent urinary tract infection (rUTI) in women (≥ 20 and \\\u003C 76 years old) with a medical history. It will also investigate the safety and the impact on the Quality of Life improvement of drug U101. The main questions it aims to answer are:\n\n* Does the drug prevent or decrease the recurrence of urinary tract infection (UTI) during the 24-week treatment?\n* Will the Quality of Life be improved during the 24-week treatment?\n* What medical problems do participants have when taking drug U101?\n\nResearchers will compare drug U101 to a placebo (a look-alike substance that contains no drug) to see if drug U101 works to prevent rUTI.\n\nParticipants will:\n\n* Orally take drug U101 or placebo every day for 24 weeks in the main study, three times per day (TID) for 8 weeks and twice per day (BID) for 16 weeks.\n* Visit the site once every 4 weeks for checkups and tests during the main study.\n* be asked to enroll in extensional study (the open-label extension (OLE) with drug U101 treatment or the Safety Follow-Up Visits with no investigational product treatment) for 24 weeks after they complete the 24-week main study.\n* Visit the site when the suspected UTI occurred during the main study or the extension study.",[30],[77,78,79,34,80,81,82,83,84,85,86,87],"recurrent urinary tract infections","recurrent urinary tract infections in women","rUTI","rUTIs","UTIs","pentosan polysulfate sodium","PPS","Glycosaminoglycan","Glycosaminoglycans","GAG","GAGs","2025-09-14",{"date":50,"type":51},{"date":91,"type":51},"2020-10-14",{"date":93,"type":22},"2028-07-31",{"name":95,"class":96},"TCM Biotech International Corp.","INDUSTRY",13]