[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06940622":3,"trial-entities:NCT06940622":142,"trial-summary:NCT06940622":146},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":28,"study_type":38,"primary_purpose":39,"phases":40,"enrollment_info":42,"interventions":45,"primary_outcomes":55,"secondary_outcomes":60,"sex":70,"minimum_age":71,"maximum_age":72,"healthy_volunteers":15,"eligibility_criteria":73,"std_ages":106,"locations":109,"central_contacts":129,"overall_officials":137,"references":140,"see_also_links":141},"NCT06940622","STU-2024-1090","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","RECRUITING","2030-09-30","2025-09","2025-09-22","2025-08-01","University of Texas Southwestern Medical Center","OTHER",false,"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.","The proposed study on D-mannose prophylaxis is designed to address a critical unmet medical need to improve the understanding and prevention of rUTI (recurrent urinary tract infection) in post-menopausal women, a population disproportionately affected by rUTI and understudied. The efficacy of D-mannose on preventing uncomplicated rUTI will be elucidated, and additional study measures (including urine culture and one-hour D-mannose test results) may help establish an ideal candidate for responding to daily D-mannose intake over time. The proposed study will follow CONSORT guidelines for randomized clinical trial studies.\n\nAim 1. Test the hypothesis that D-mannose provides effective rUTI prophylaxis in post-menopausal women over 6 months.\n\nAim 2. Test the hypothesis that D-mannose provides effective rUTI prophylaxis in post-menopausal women beyond 6 months and up to one year.\n\nThe overarching hypotheses are that (1) D-mannose will be found superior to placebo in preventing rUTI in post-menopausal women over 6 months as suggested by one prior RCT7 (Aim 1) and (2) D-mannose will remain effective for rUTI prophylaxis up to one year (Aim 2).\n\nNinety (90) women currently UTI-free and with a history of uncomplicated rUTI, defined as ≥ 2 symptomatic UTIs in 6 months or ≥ 3 symptomatic UTIs in 12 months, will be enrolled and randomized (2:1 ratio) to receive D-mannose (2g, i.e., 4 x 500mg capsules) or placebo daily for 12 months.",[19,20,21,22,23,24,25,26,27],"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",[29,30,31,32,33,34,35,36,37],"D-mannose","dmannose","uti","ruti","recurrent urinary tract infection","urinary tract infection","cystitis","chronic uti","chronic cystitis","INTERVENTIONAL","PREVENTION",[41],"NA",{"count":43,"type":44},90,"ESTIMATED",[46,51],{"type":47,"name":48,"description":49,"armGroupLabels":50},"DIETARY_SUPPLEMENT","D-Mannose","D-mannose (2g, i.e., 4 x 500mg capsules) daily for 12 months.",[29],{"type":47,"name":52,"description":53,"armGroupLabels":54},"Placebo","Placebo daily for 12 months.",[52],[56],{"measure":57,"description":58,"timeFrame":59},"Failure rate","To determine whether prophylaxis with D-mannose reduces the incidence of UTI episodes compared to placebo. \"Failure rate,\" defined as having 2 UTIs in 6 months or 3 in one year.","Through study completion, an average of 5 years",[61,64,67],{"measure":62,"description":63,"timeFrame":59},"Number of UTI antibiotic treatments","To investigate if D-mannose reduces the need for antibiotic use due to recurrent UTIs (measured as number of antibiotic courses for symptomatic culture-proven UTI episodes) compared to placebo.\n\nNumber of UTI antibiotic treatments during the 6 months of treatment. If the participant receives \\>1 antibiotic course for UTI without symptom relief, it is regarded as one episode and counted as one antibiotic treatment. If there has been an asymptomatic period of at least 14 days in between two UTI antibiotic courses, this will be regarded as a new antibiotic treatment.",{"measure":65,"description":66,"timeFrame":59},"Symptom severity","To investigate if D-mannose reduces the severity of UTI symptoms compared to placebo. Record symptom severity using a validated UTI symptom assessment questionnaire.",{"measure":68,"description":69,"timeFrame":59},"Serious adverse events associated with D-mannose","To determine the frequency of serious adverse events associated with D-mannose. Number of participants who experienced adverse events \\>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCA version 5.0.","FEMALE","55 Years","85 Years",{"inclusion":74,"exclusion":80,"raw_text":105},[75,76,77,78,79],"Female, post-menopausal, age ≥ 55 years old","Diagnosis of recurrent UTI, defined as ≥ 3 symptomatic culture-proven UTI episodes in 12 months or ≥ 2 in 6 months.","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).","Able to attend all follow-up appointments for the study.","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.",[81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104],"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.","Complicated UTIs, including need for catheter drainage or intermittent catheterization, neurogenic bladder, bladder augmentation, or urinary diversion.","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.","Evidence of upper tract infection (pyelonephritis), including temperature higher than 38°C, flank\u002Flumbar pain or tenderness","Diagnosis of interstitial cystitis or overactive bladder syndrome","Prophylactic antibiotics started in the last 3 months and unwilling to discontinue, or intention to start in the next 12 months","Use of Uromune or other vaccine approaches to reduce rUTI","Participation in a research study involving an investigational product in the past 12 weeks","Receipt of phage treatment","History of chronic diarrhea requiring regular therapy","Inability to swallow or known history of gastrointestinal malabsorption","History of recurrent vaginal yeast infections","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).","Nursing home resident","BMI \\>40","Multi-Vitamins and Multi-Mineral capsules","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)","Probiotics","Cranberry Mannose or Cranberry Extract Weight loss products to avoid","Medifast","Vitafusion","OptiVin Products","Appetite Suppressants","Keto-Fuel","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",[107,108],"ADULT","OLDER_ADULT",[110],{"facility":13,"status":8,"city":111,"state":112,"zip":113,"country":114,"contacts":115,"geoPoint":126},"Dallas","Texas","75390","United States",[116,121,123],{"name":117,"role":118,"phone":119,"email":120},"Sonobia Garrett, BSHS","CONTACT","214-645-8787","sonobia.garrett@utsouthwestern.edu",{"role":118,"email":122},"philippe.zimmern@utsouthwestern.edu",{"name":124,"role":125},"Philippe E Zimmern, MD","PRINCIPAL_INVESTIGATOR",{"lat":127,"lon":128},32.78306,-96.80667,[130,134],{"name":131,"role":118,"phone":132,"email":133},"Jessica de Araujo Paula","2146458787","jessica.dearaujopaula@utsouthwestern.edu",{"name":135,"role":118,"phone":132,"email":136},"Meghan Leak","meghan.leak@utsouthwestern.edu",[138],{"name":139,"affiliation":13,"role":125},"Philippe Zimmern, MD",[],[],{"nct_id":4,"conditions":143,"biomarkers":145},[144],"Recurrent urinary tract infection",[],{"nct_id":4,"found":147,"summary":148,"prompt_version":158},true,{"design":149,"status":150,"heading":151,"summary":152,"follow_up":153,"word_count":154,"commitments":155,"compensation":156,"drugs_mentioned":157},"This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either D-mannose or a placebo, and neither you nor your doctors will know which you are receiving. It plans to enroll 90 women.","completed","D-mannose for Preventing Recurrent Urinary Tract Infections","This study is looking at whether a dietary supplement called D-mannose can help prevent recurrent urinary tract infections (UTIs) in post-menopausal women. You might be able to join if you are a woman aged 55 to 85, have gone through menopause, and have a history of frequent UTIs (at least 3 in 12 months or 2 in 6 months). You must also be free of a UTI when you join the study. Participants will either take D-mannose or a placebo (an inactive substance) daily for 12 months. The main goal is to see if D-mannose reduces the number of UTIs over an average of 5 years. The study is currently recruiting 90 participants.","Participants will be followed through study completion, an average of 5 years.",113,"You would take D-mannose or a placebo daily for 12 months. The study will track your progress through study completion, an average of 5 years.","Not stated in the trial record.",[48,52],"v2"]