protocolSection identificationModule nctId: NCT06290518, orgStudyIdInfo id: PROBIFERT P051, briefTitle: Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-09-01, primaryCompletionDateStruct date: 2023-05-03, completionDateStruct date: 2024-01-29, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Biosearch S.A., class: INDUSTRY, collaborators name: Hospital San Carlos, Madrid, collaborators name: Universidad Complutense de Madrid, descriptionModule briefSummary: The objective of the project is to elucidate if the oral administration of Ligilactobacillus salivarius CECT5713 is capable of improving the rates of term pregnancies in couples with infertility problems of unknown cause. On the other hand, the project is aimed to detect microbiological, immunological and hormonal markers that allow the identification of couples in which the administration of the strain could be particularly effective. This is a randomized, double-blind, parallel-group controlled nutritional intervention study. The intervention (Ligilactobacillus salivarius CECT5713 or placebo) will be performed during the 6 months prior to the fertility treatment and during the first IVF cycle (estimated 1-2 months). In case of pregnancy, the woman will continue the treatment until 12 weeks of gestation., conditionsModule conditions: Infertility Unexplained, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assignment Volunteers are classified into 2 groups. All women in the probiotic group consume (oral route) a daily capsule with \~50 mg of freeze-dried probiotic (9.5 log10 CFU of L. salivarius CECT5713; excipient: maltodextrin). All women in the placebo group consume (oral route) a daily capsule with \~50 mg of maltodextrin., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: TRIPLE, maskingDescription: Triple (Participant, Care Provider, Investigator) Only one person of the collaborator that provides the capsules (Biosearch Life) know the correspondecs between each reference (one reference per each subject) and the arm (probiotic or placebo). The codes are blinded for the participant, the care provider and the investigator., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: Ligilactobacillus salivarius CECT5713, interventions name: Placebo, outcomesModule primaryOutcomes measure: Successful pregnancies, secondaryOutcomes measure: Modification of the vaginal microbiota, secondaryOutcomes measure: Vaginal immunomodulation, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Biosearch S.A.U., city: Granada, zip: 18004, country: Spain, geoPoint lat: 37.18817, lon: -3.60667, locations facility: Hospital Clínico San Carlos, city: Madrid, zip: 28040, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Universidad Complutense de Madrid, city: Madrid, zip: 28040, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False