[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06665126":3,"trial-entities:NCT06665126":94,"trial-summary:NCT06665126":98},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":45,"secondary_outcomes":50,"sex":57,"minimum_age":58,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":59,"std_ages":77,"locations":80,"central_contacts":90,"overall_officials":91,"references":92,"see_also_links":93},"NCT06665126","20397","A Study to Evaluate the Effects of a Prebiotic and Probiotic Supplement to Provide Relief From Symptoms Associated With Bacterial Vaginosis and Yeast Infections.","COMPLETED","2025-03-03","2026-08","2026-08-13","2024-10-04","Happy V","INDUSTRY",false,"This virtual randomized controlled trial evaluates the efficacy of a prebiotic and probiotic supplement in providing relief from symptoms associated with bacterial vaginosis and yeast infections. Participants will be randomized into three groups-test product, active placebo, and excipient placebo-and will take two capsules daily for 30 days. The study will assess the effects on vaginal microbiome, symptoms of bacterial vaginosis and yeast infections, and overall vaginal health.",null,[18,19],"Bacterial Vaginosis","Yeast Infection",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},120,"ACTUAL",[29,35,40],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DIETARY_SUPPLEMENT","Prebiotic + Probiotic Supplement","This intervention includes a combination of prebiotics and probiotics designed to promote vaginal and digestive health. The supplement contains Biotin, Lactobacillus acidophilus (as LA-14®), Bifidobacterium lactis (HN019™), Lactobacillus rhamnosus (as HN001™), Lactobacillus crispatus (as CCFM1110™), Lactobacillus gasseri (as HLG13™), Lactobacillus reuteri (as HR7™), Bacillus subtilis (as DE111®), PreforPro®, White Rice Flour, Magnesium Stearate (Vegetable Source), Silicon Dioxide (Bamboo Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.",[34],"Test Product Group",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Active Placebo Supplement","The active placebo supplement contains similar probiotic strains without the prebiotic component. Ingredients include Biotin, Lactobacillus acidophilus, Bifidobacterium lactis, Lactobacillus rhamnosus, Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus reuteri, Bacillus subtilis, Inulin (from Chicory Root), White Rice Flour, Magnesium Stearate (Vegetable Source), Silicon Dioxide (Bamboo Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.",[39],"Active Placebo Group",{"type":30,"name":41,"description":42,"armGroupLabels":43},"Excipient Placebo Supplement","The excipient placebo supplement contains no active ingredients related to prebiotics or probiotics. It includes White Rice Flour, Magnesium Stearate (Vegetable Source), and Cellulose (Vegetable Capsule). Participants take two capsules daily with food for 30 days.",[44],"Excipient Placebo Group",[46],{"measure":47,"description":48,"timeFrame":49},"Change in Vaginal Microbiome","This outcome measures the change in vaginal microbiome parameters from Baseline to Day 30. The vaginal microbiome will be assessed using microbiome sequencing at both Baseline and Day 30.","Baseline, Day 30",[51,55],{"measure":52,"description":53,"timeFrame":54},"Change in Perceived Symptoms of Bacterial Vaginosis","This outcome measures the change in symptoms associated with bacterial vaginosis and yeast infections (e.g., itchiness, odor, abnormal discharge) as reported by participants through questionnaires.","Baseline, Day 1, Day 7, Day 14, Day 21, Day 30",{"measure":56,"description":53,"timeFrame":54},"Change in Perceived Symptoms of Yeast Infections","FEMALE","25 Years",{"inclusion":60,"exclusion":68,"raw_text":76},[61,62,63,64,65,66,67],"Women","Age 25+","Self-reported concerns symptoms associated with bacterial vaginosis or candida overgrowth, including itchiness, redness, abnormal discharge, and an unpleasant odor.","Suffers from digestive issues, including bloating, gas, or other digestive discomfort.","Generally healthy - do not live with any uncontrolled chronic diseases.","Willing to avoid using any vaginal health-related medications, supplements, and herbal remedies for the duration of this study.","If taking oral supplements or herbal remedies targeted at vaginal health, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration.",[69,70,71,72,73,74,75],"Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders","Planning to undergo any procedure related to their vaginal health.","Started any new medications or supplements that target vaginal health in the past 3 months.","Anyone with known severe allergic reactions that require the use of an Epi-Pen, or any known allergies to any of the product ingredients","Women who are pregnant, breastfeeding, or attempting to conceive","Unwilling to follow the study protocol","Anyone who has undergone any surgeries or invasive treatments in the last three months or has any planned during the study period.","Inclusion Criteria:\n\n* Women\n* Age 25+\n* Self-reported concerns symptoms associated with bacterial vaginosis or candida overgrowth, including itchiness, redness, abnormal discharge, and an unpleasant odor.\n* Suffers from digestive issues, including bloating, gas, or other digestive discomfort.\n* Generally healthy - do not live with any uncontrolled chronic diseases.\n* Willing to avoid using any vaginal health-related medications, supplements, and herbal remedies for the duration of this study.\n* If taking oral supplements or herbal remedies targeted at vaginal health, has been consistently taking these for at least 3 months prior to starting the study and is willing to maintain this routine for the study duration.\n\nExclusion Criteria:\n\n* Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders\n* Planning to undergo any procedure related to their vaginal health.\n* Started any new medications or supplements that target vaginal health in the past 3 months.\n* Anyone with known severe allergic reactions that require the use of an Epi-Pen, or any known allergies to any of the product ingredients\n* Women who are pregnant, breastfeeding, or attempting to conceive\n* Unwilling to follow the study protocol\n* Anyone who has undergone any surgeries or invasive treatments in the last three months or has any planned during the study period.",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"Citruslabs","Santa Monica","California","90404","United States",{"lat":88,"lon":89},34.01949,-118.49138,[],[],[],[],{"nct_id":4,"conditions":95,"biomarkers":97},[18,96],"Yeast Infections",[],{"nct_id":4,"found":99,"summary":100,"prompt_version":110},true,{"design":101,"status":102,"heading":103,"summary":104,"follow_up":105,"word_count":106,"commitments":107,"compensation":108,"drugs_mentioned":109},"This is a virtual randomized controlled trial with 120 planned participants. Participants will be assigned by chance to one of three groups: the test product, an active placebo, or an excipient placebo.","completed","Study of Prebiotic and Probiotic Supplement for Vaginal and Yeast Infections","This study is looking into whether a combination of a prebiotic and probiotic supplement can help relieve symptoms of bacterial vaginosis (an imbalance of bacteria in the vagina) and yeast infections. You may be able to join if you are a woman aged 25 or older, have concerns about symptoms like itching, redness, unusual discharge, or odor, and also experience digestive issues. Participants will take one of three dietary supplements daily for 30 days: the Prebiotic + Probiotic Supplement, an Active Placebo Supplement (with probiotics but no prebiotics), or an Excipient Placebo Supplement (no active ingredients). The study will measure changes in your vaginal microbiome (the community of microorganisms in your vagina) to see if the supplements are effective. The current recruitment status is unclear.","Your vaginal microbiome will be measured at Day 30, which is the end of the treatment period.",125,"You would take two capsules daily with food for 30 days. Your vaginal microbiome will be measured at the start and end of the study.","Not stated in the trial record.",[31,36,41],"v2"]