[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Carleton University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100632351","probiotic-research-on-safety-palatability-efficacy-and-receptivity-100632351",false,"NCT07512557","Probiotic Research On Safety, Palatability, Efficacy and Receptivity","Evaluating the Effectiveness and Feasibility of a Probiotic Intervention to Improve Nutrient Levels in Reproductive-Aged Women: A Pilot Study","PROSPER","Inclusion Criteria:\n\n* Non-pregnant and non-lactating\n* English speaking with the ability to give informed consent\n* 18-40 years of age (inclusive)\n* Women who are biologically female\n* Willing and able to agree to the requirements and lifestyle restrictions of this study\n* Able to understand and read the questionnaires in English and carry out all study-related procedures\n* Located in the greater Ottawa area and a resident of Ontario\n\nExclusion Criteria:\n\n* Individuals who are lactating, pregnant, or planning to become pregnant during the study\n* Individuals who are not maintaining adequate birth control measures\n* Adequate birth control measures include any option that will adequately prevent pregnancy including: contraceptives, lifestyle choices, complete abstinence, or as a result of other medical methods, procedures, or conditions\n* Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients\n* Are using vitamin and mineral supplements containing B vitamins\n* Intake of a B-vitamin-containing micronutrient supplement or probiotic product in the previous 4 weeks\n* Expecting to change diet and exercise regimen in the next 4 weeks\n* Have planned surgery during the course of the study\n* Use of investigational product(s) in another research study within 30 days prior to the baseline visit or during the study duration\n* Taking probiotics during the study period\n* More than 2 alcoholic beverages per day throughout the duration of the study\n* Known medical history of specific conditions including: Gastrointestinal disorders: celiac disease, ulcerative colitis, and Crohn's disease; Gastric cancer and gastric polyps; Inflammatory bowel diseases; Helicobacter pylori infection; Gastrectomy, duodenal bypass, bariatric surgery",true,"FEMALE","18 Years","40 Years",{"count":22,"type":23},82,"ESTIMATED","INTERVENTIONAL",[26],"NA","The goal of this pilot study is to determine if taking a commercially available probiotic product can influence levels of vitamins B12, B6 and folate after a 4-week supplementation period in reproductive-aged women without any micronutrient deficiencies. The main question it aims to answer is:\n\n• Does a probiotic product influence blood folate, vitamin B12 and B6 levels in reproductive-aged women when it is taken regularly for 4 weeks?\n\nParticipants in this clinical trial will consume the probiotic product containing multiple probiotic strains regularly for 4 weeks. One group will consume one capsule per day at a particular dose, and the second group will consume two capsules per day at another dose. Participants will also have to:\n\n* Attend two in-person visits with a researcher: at enrolment (baseline), and endline (day 28\u002F4 weeks)\n* Provide a blood sample at baseline (day 0) and endline (day 28\u002F4 weeks)\n* Provide two stool samples (following each in-person visit)\n* Complete an online \"study diary\" every two weeks for 4 weeks (2 study diaries)\n* Complete two sets of online questionnaires (following each in-person visit)\n* Complete two sets of dietary assessments (following each in-person visit)",[29],"Probiotic Intervention",[31,32,33],"B vitamins","Reproductive-aged women","Probiotics","RECRUITING","2026-04-01",{"date":37,"type":38},"2026-04-06","ACTUAL",{"date":40,"type":38},"2025-11-28",{"date":42,"type":23},"2026-07-30",{"name":44,"class":45},"Carleton University","OTHER",""]