[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478211":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":25,"locations":35,"responsibleParty":47,"collaborators":49,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":25,"eligibilityCriteria":62,"healthyVolunteers":63,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":25,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":79,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Novozymes A\u002FS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lactobacillus plantarum DSM 33464, MegaMetalliQ","EXPERIMENTAL","Subjects will take 1 sachet of Lactobacillus plantarum DSM 33464 (2 g) per day for 8 weeks",[13],"Dietary Supplement: Lactobacillus plantarum DSM 33464, MegaMetalliQ",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo group","PLACEBO_COMPARATOR","Subjects will take 1 sachet of Placebo (2 g) per day for 8 weeks",[19],"Dietary Supplement: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Pour Lactobacillus Plantarum DSM 33464 sachet into moderate amount of water, slightly stir, fully dissolve, drink 0.5 hour before having meal, one at a time.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","Pour placebo sachet into moderate amount of water, slightly stir, fully dissolve, drink 0.5 hour before having meal, one at a time.",[15],[31],{"name":32,"affiliation":33,"role":34},"Alejandra de Jesús Cantoral Preciado, Ph.D","Universidad Iberoamericana A.C.","PRINCIPAL_INVESTIGATOR",[36],{"facility":33,"status":25,"city":37,"state":25,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":25},"Mexico City","01219","Mexico","MX",{"type":42,"coordinates":43},"Point",[44,45],-99.12766,19.42847,{"lat":45,"lon":44},{"type":48,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[50,53],{"name":51,"class":52},"Universidad Iberoamericana A.C., Mexico","OTHER",{"name":54,"class":55},"Linus Biotechnology Inc","UNKNOWN","100478211","effect-of-lactobacillus-plantarum-dsm-33464-on-blood-lead-levels-in-young-women-of-child-bearing-age-100478211",false,"NCT05507021","Effect of Lactobacillus Plantarum DSM 33464 on Blood Lead Levels in Young Women of Child-bearing Age","A Clinical Trial to Evaluate the Efficacy and Safety of Lactobacillus Plantarum DSM 33464 (SmartGuard \u003CTM>\u002FMegametalliQ \u003CTM>) to Reduce Blood Lead Levels in Young Women of Child-bearing Age (18 to 40 Years Old)","Inclusion Criteria:\n\n* Women between 18 and 40 years old.\n* Women with capillary blood Pb levels between 3.3 µg\u002FdL (Lead Care detection limit) and 25 µg\u002FdL.\n* Residents of Santa Fe, Mexico City.\n* Women of childbearing age, using the same contraceptive method (any) since at least 3 cycles before the start of the study and who agree to maintain it for the entire duration of the study.\n* Women who give their informed consent in writing.\n\nExclusion Criteria:\n\n* Women with a diagnosed history of diseases of the nervous system, genetic diseases, endocrine diseases, lung diseases, serious or uncontrolled cardiovascular diseases, clinically significant kidney or liver diseases, diseases of the blood system, any other clinically significant disease, and others that the investigators consider would increase the risk of disease of the subject.\n* Pregnant or lactating women, who intend to become pregnant or who declare that they have intended to become pregnant within the previous 3 months.\n* Consumption of nutritional supplements 4-6 weeks before screening.\n* Consumption of probiotic or antibiotic products in the last two weeks.\n* Women who have received chelation therapy for Pb poisoning.\n* Known or suspected allergy or sensitivity to study products or any component tested in the trial.\n* Participation in another clinical trial or food study 4 weeks before and during the trial.",true,"FEMALE","18 Years","40 Years",{"count":68,"type":69},47,"ACTUAL","INTERVENTIONAL",[72],"NA","We hypothesize that Lactobacillus Plantarum DSM 33464 reduce lead levels. Approximately 200 women 18 to 40 will be screened for blood lead levels. From that pool of subjects, 40 healthy women aged 18 to 40 years will participate in this randomized, placebo controlled pilot clinical trial. Each participant will receive 1 sachet of Lactobacillus Plantarum DSM 33464 (2g) per day for 8 weeks. The participants will be evaluated for several health measures, e.g. Blood, urine and hair will be collected and analyzed for lead (Pb) as the primary target compound and other chemicals as secondary target compounds. Adverse events will be recorded throughout the trial. Stool samples will also be collected at the beginning and end of the study to undertake a microbiome analysis.",[75],"Elevated Blood Lead Levels",[77,78],"Blood lead level","Lactobacillus Plantarum DSM 33464","COMPLETED","2024-09-19",{"date":82,"type":69},"2024-09-23",{"date":84,"type":69},"2022-10-31",{"date":86,"type":69},"2023-04-12",{"name":5,"class":6},1]