[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643484":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":40,"locations":47,"responsibleParty":61,"collaborators":45,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":45,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":45,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":86,"whyStopped":45,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Qilu Hospital of Shandong University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotics + Standard Behavioral Therapy","EXPERIMENTAL","Participants assigned to this arm will receive a probiotic powder compound containing Lactobacillus plantarum, Lactobacillus casei, and Lactobacillus acidophilus. The probiotic powder will be dissolved in a glass of water and taken orally once a day for 12 weeks. In addition to the probiotic, participants will receive standard behavioral therapy for overactive bladder (OAB) administered by trained clinical staff. This comprehensive, individualized therapy includes six core modules: bowel management (e.g., dietary fiber intake), fluid and diet modification (e.g., limiting caffeine and other bladder irritants), weight and smoking management, bladder training (including voiding diaries, delayed voiding, and urge suppression techniques), pelvic floor muscle training (PFMT), and personalized follow-up adjustments.",[13],"Dietary Supplement: Multi-strain Probiotic Compound",{"label":15,"type":10,"description":16,"interventionNames":17},"Placebo + Standard Behavioral Therapy","Participants assigned to this arm will receive a placebo powder dissolved in a glass of water, taken orally once a day for 12 weeks. The placebo is composed of inert excipients (such as maltodextrin) and contains no active bacteria, but is identical to the active probiotic product in color, texture, taste, and solubility. In addition to the placebo, participants will receive the exact same standard behavioral therapy for OAB as the experimental group. This comprehensive, individualized therapy includes six core modules: bowel management, fluid and diet modification (e.g., limiting bladder irritants), weight and smoking management, bladder training (including voiding diaries, delayed voiding, and urge suppression techniques), pelvic floor muscle training (PFMT), and personalized follow-up adjustments.",[18],"Other: Placebo",[20,29],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Multi-strain Probiotic Compound","The active intervention consists of a probiotic powder containing Lactobacillus plantarum DY-1, Lactobacillus casei KDB-LC, and Lactobacillus acidophilus KDB-03. The powder is to be dissolved in a glass of water and administered orally once a day for 12 weeks.",[9],[26,27,28],"Lactobacillus plantarum","Lactobacillus casei","Lactobacillus acidophilus",{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo","An inactive placebo powder composed of inert excipients (maltodextrin) containing no active bacteria. It is visually and organoleptically identical to the active probiotic product (matching in color, texture, taste, and solubility). The powder is to be dissolved in a glass of water and administered orally once a day for 12 weeks.",[15],[34],"Maltodextrin powder",[36],{"name":37,"affiliation":38,"role":39},"Yuchao Sun, Bachelor","Shandong University","STUDY_CHAIR",[41],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},"Yan Li, doctor","CONTACT","+86 18560089113",null,"yanli@sdu.edu.cn",[48],{"facility":5,"status":45,"city":49,"state":50,"zip":45,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Jinan","Shandong","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.99722,36.66833,{"lat":57,"lon":56},[60],{"name":42,"role":43,"phone":44,"phoneExt":45,"email":46},{"type":62,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100643484","efficacy-of-probiotics-for-oab-patients-with-anxiety-100643484",false,"NCT07635212","Efficacy of Probiotics for OAB Patients With Anxiety","Evaluating the Efficacy of Probiotics as an Adjunct to Behavioral Therapy in Patients With Overactive Bladder (OAB) and Anxiety Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n1. Aged between 18 and 80 years old (inclusive).\n2. Able to understand study-related instructions and independently complete the required questionnaires.\n3. Able to provide written informed consent and willing to comply with all study requirements, including completing diaries\u002Fquestionnaires and refraining from taking any other probiotic or prebiotic supplements during the 3-month study period.\n4. Meet the diagnostic criteria for Overactive Bladder (OAB) as defined by the International Continence Society (ICS) (urgency as the core symptom, with or without urgency urinary incontinence, frequency, and nocturia); have an Overactive Bladder Symptom Score (OABSS) ≥ 6; and have a daytime voiding frequency of ≥ 8 times.\n5. Have a preliminary diagnosis of \"Generalized Anxiety Disorder\" or \"Anxiety state\" assessed by a psychiatrist or trained investigator according to DSM-5 or ICD-10 criteria, or have a Generalized Anxiety Disorder-7 (GAD-7) scale score ≥ 5.\n6. If previously using any over-the-counter medications or other products for anxiety relief (e.g., magnesium, melatonin, anticholinergic drugs) or receiving psychotherapy, these must have been discontinued for at least 4 weeks prior to randomization and must remain completely discontinued throughout the entire study period.\n\nExclusion Criteria:\n\n1. Presence of organic diseases of the urinary system (e.g., urinary tract obstruction, tumors, stones, acute infection, interstitial cystitis, stress urinary incontinence).\n2. Neurogenic bladder caused by neurological diseases or a history of pelvic surgery.\n3. Use of antibiotics, probiotics, or prebiotics within the past 1 month prior to screening.\n4. Any adjustment to medications used for treating OAB or anxiety within the past 2 weeks prior to screening.\n5. Pregnant or lactating women, or individuals with a known allergy to any components of the study preparation.\n6. Suffering from other severe psychiatric\u002Fpsychological disorders or severe systemic diseases (e.g., uncontrolled diabetes mellitus, severe obesity).","ALL","18 Years","80 Years",{"count":74,"type":75},218,"ESTIMATED","INTERVENTIONAL",[78],"NA","The goal of this clinical trial is to learn if probiotics can help improve symptoms in adults with overactive bladder (OAB) and anxiety. The main questions it aims to answer are:\n\n1. Does taking probiotics lower the number of times participants need to urinate in a 24-hour period?\n2. Does taking probiotics lower participants' anxiety levels?\n\nResearchers will compare probiotics to a placebo (a look-alike powder that contains no active bacteria) to see if the probiotics work better to treat OAB and anxiety when both groups also use standard behavioral therapy (like bladder training).\n\nParticipants will:\n\n1. Take probiotics or a placebo twice a day for 12 weeks.\n2. Learn and practice bladder training using a manual and educational videos.\n3. Keep a 3-day diary of when they urinate and what they drink at the beginning, middle, and end of the study.\n4. Answer survey questions about their anxiety and quality of life during clinic visits.\n5. Provide urine samples for routine checkups to ensure they do not have infections.",[81],"Overactive Bladder (OAB)",[83,84,85],"probiotics","OAB","overactive bladder","NOT_YET_RECRUITING","2026-06-03",{"date":89,"type":90},"2026-06-09","ACTUAL",{"date":92,"type":75},"2026-07-01",{"date":94,"type":75},"2028-12-31",{"name":5,"class":6},1]