[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548752":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":47,"centralContacts":36,"locations":55,"responsibleParty":68,"collaborators":70,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":36,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":106,"whyStopped":36,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"dsm-firmenich Switzerland AG","INDUSTRY",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"L. reuteri AMBV339","ACTIVE_COMPARATOR","Probiotic strain, 1B AFU (per day for 28 days in capsule format)",[13],"Dietary Supplement: Limosilactobacillus reuteri AMBV339",{"label":15,"type":10,"description":16,"interventionNames":17},"Humiome B2","73 mg colon delivered riboflavin containing 10 mg pure riboflavin (per day for 28 days in capsule format)",[18],"Dietary Supplement: Humiome B2",{"label":20,"type":10,"description":21,"interventionNames":22},"Combination arm","Probiotic strain, 1B AFU + 73 mg colon delivered riboflavin containing 10 mg pure riboflavin (per day for 28 days in capsule format)",[23],"Dietary Supplement: Limosilactobacillus reuteri AMBV339 + Humiome B2",{"label":25,"type":26,"description":27,"interventionNames":28},"Placebo","PLACEBO_COMPARATOR","Microcrystalline cellulose (per day for 28 days in capsule format)",[29],"Dietary Supplement: Placebo",[31,37,40,44],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DIETARY_SUPPLEMENT","Limosilactobacillus reuteri AMBV339","Limosilactobacillus reuteri AMBV339 is a probiotic strain",[9],null,{"type":32,"name":15,"description":38,"armGroupLabels":39,"otherNames":36},"Colon-delivered Riboflavin",[15],{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":36},"Limosilactobacillus reuteri AMBV339 + Humiome B2","Combination of supplements used in arm 1 and 2",[20],{"type":32,"name":25,"description":45,"armGroupLabels":46,"otherNames":36},"Microcrystalline cellulose",[25],[48,52],{"name":49,"affiliation":50,"role":51},"Veronique Verhoeven, Dr","University of Antwerp Department of Family Medicine and Population Health","PRINCIPAL_INVESTIGATOR",{"name":53,"affiliation":54,"role":51},"Sarah Lebeer, Dr","University of Antwerp Department of Bioscience Engineering",[56],{"facility":57,"status":36,"city":58,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":36},"Lab of Applied Microbiology and Biotechnology, University of Antwerp","Antwerp","2020","Belgium","BE",{"type":63,"coordinates":64},"Point",[65,66],4.40026,51.22047,{"lat":66,"lon":65},{"type":69,"investigatorFullName":36,"investigatorTitle":36,"investigatorAffiliation":36,"oldNameTitle":36,"oldOrganization":36},"SPONSOR",[71],{"name":72,"class":73},"Universiteit Antwerpen","OTHER","100548752","investigating-the-impact-of-humiome-b2-colon-delivered-riboflavin-and-riboflavin-overproducer-probiotic-strain-limosilactobacillus-reuteri-ambv339-on-intestinal-and-vaginal-microbiome-and-health-of-healthy-adult-women-the-viab2l-project-100548752",false,"NCT06425081","Investigating the Impact of Humiome B2 (Colon Delivered Riboflavin) and Riboflavin-overproducer Probiotic Strain Limosilactobacillus Reuteri AMBV339 on Intestinal and Vaginal Microbiome and Health of Healthy Adult Women (The VIAB2L Project)","Investigating the Impact of Humiome B2 (Colon Delivered Riboflavin) and Riboflavin-overproducer Probiotic Strain Limosilactobacillus Reuteri AMBV339 on Intestinal and Vaginal Microbiome and Health (The VIAB2L Project)","VIAB2L","Inclusion Criteria:\n\n* Women of reproductive age (appr. 18-45 years old)\n* Women of self-reported good general health\n* Living in Flanders and speaking Dutch\n* Using a combination contraceptive pill (without stop week) during the study and preferably at least three months before the study OR having a hormonal intrauterine device during the study and preferably at least three months before the study\n* Subjects willing and able to give written informed consent and to understand, to participate and to comply with the clinical study requirements.\n\nExclusion Criteria:\n\n* Current pregnancy or breastfeeding\n* Antibiotic\u002Fantimycotic use during the last three months before the study\n* Use of group B vitamin supplements or vitamin C during the study (record vitamin use via questionnaires)\n* Ketogenic diet during the study and during the last two weeks before the study\n* Oral and vaginal probiotic, prebiotic, and postbiotic and synbiotic supplementation during the study or recent use during the last two weeks before the study\n* Vaginal douching during the study\n* Presence of general infection\n* Having a reproductive disorder or current vaginal infection or vaginal symptoms (VVC, BV, AV, etc.)\n* Having a gastro-intestinal disorder or current GIT infections or gastrointestinal disorders (Crohn, IBS, IBD, etc.)\n* Having any other medical condition that gives rise to exclusion from the study according to the responsible clinician\u002Fprincipal investigator of the study\n* Participation in another clinical trial",true,"FEMALE","18 Years","45 Years",{"count":87,"type":88},185,"ACTUAL","INTERVENTIONAL",[91],"NA","The goal of this clinical trial is to learn if the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination can change the gut and vaginal microbiome and metabolomics. It will also learn about the safety of the investigational product. The main questions it aims to answer are:\n\nDo the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination modify gut microbiome? Do the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination modify gut microbiome?\n\nResearchers will compare the probiotic strain Limosilactobacillus reuteri AMBV339 or colon-delivered riboflavin or their combination to a placebo (a look-alike substance that contains no drug) to see if they can change gut and vaginal microbiome. Intervention period is 28 days.",[94],"Microbial Colonization",[96,97,98,99,100,101,102,103,104,105],"Probiotic","vitamin","Riboflavin","Vitamin B2","lactobacillus","microbiome","gut microbiome","vaginal microbiome","women's health","gut health","COMPLETED","2025-05-06",{"date":109,"type":88},"2025-05-09",{"date":111,"type":88},"2024-09-09",{"date":113,"type":88},"2025-01-30",{"name":5,"class":6},1]