Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT06290518
Status:
COMPLETED
Last Update Posted:
2024-03-04
First Post:
2024-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], '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.'}, 'primaryPurpose': 'BASIC_SCIENCE', '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-02-26', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful pregnancies', 'timeFrame': '9 months', 'description': 'Total number of pregnancies with delivery of a healthy baby'}], 'secondaryOutcomes': [{'measure': 'Modification of the vaginal microbiota', 'timeFrame': '9 months', 'description': 'Variation in the concentration of lactobacilli and other microbes in vaginal samples (Staph ylococcus, Streptococcus, Enterococcus, Corynebacterium, Rothia, Arthrobacter, Acinetobacter, Actinomyces)'}, {'measure': 'Vaginal immunomodulation', 'timeFrame': '9 months', 'description': 'Variation in the concentration of immune factors in vaginal samples. The presence and concentration of a wide spectrum of cytokines, chemokines and growth factors (IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17, G-CSF, GM-CSF, IFN-γ, MCP-1, MIP-1β, RANTES, TGF-β1, 2 and 3, VEGF, GRO-alpha and TNF-alpha)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infertility'], 'conditions': ['Infertility Unexplained']}, 'referencesModule': {'references': [{'pmid': '33419054', 'type': 'BACKGROUND', 'citation': 'Fernandez L, Castro I, Arroyo R, Alba C, Beltran D, Rodriguez JM. Application of Ligilactobacillus salivarius CECT5713 to Achieve Term Pregnancies in Women with Repetitive Abortion or Infertility of Unknown Origin by Microbiological and Immunological Modulation of the Vaginal Ecosystem. Nutrients. 2021 Jan 6;13(1):162. doi: 10.3390/nu13010162.'}]}, '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The target is infertility of unknown origin. The outcome is a successful pregnancy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* legal age\n* Intention to achieve a pregnancy, but without achieving it;\n* Be willing to undergo in vitro fertilization treatment;\n* Be on the waiting list for the IVF cycle with an expected waiting time \\> 5 months.\n\nExclusion Criteria:\n\n* Sterility in one of the members of the couple (azoospermia; impermeability of the fallopian tubes...).\n* Genitourinary malformations;\n* Concurrence of other severe diseases (e.g.: cancer, AIDS, ALS, morbid obesity...) or uncontrolled diseases (inflammatory bowel diseases, diabetes...).\n* Treatment/intervention other than the planned IVF after the start date of the intervention.\n* Antibiotic treatment at the start date of the intervention.\n* Intention to consume another probiotic supplement in the following 3 months.\n* Participation in another clinical trial.\n* Allergic/intolerant to the excipient.\n* Inability to understand the informed consent form and/or to follow the basic instructions of the trial.'}, 'identificationModule': {'nctId': 'NCT06290518', 'briefTitle': 'Modulation of Reproductive Microbiota by Ligilactobacillus Salivarius CECT5713', 'nctIdAliases': ['NCT05896657'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosearch S.A.'}, 'officialTitle': 'Modulation of the Reproductive Microbiota as a Strategy to Increase Rates of Reproductive Success in Couples With Infertility of Unknown Origin', 'orgStudyIdInfo': {'id': 'PROBIFERT P051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic group', 'description': '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) 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.', 'interventionNames': ['Dietary Supplement: Ligilactobacillus salivarius CECT5713']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'All women in the placebo group consume (oral route) a daily capsule with \\~50 mg of maltodextrin 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.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Ligilactobacillus salivarius CECT5713', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration of a capsule containing 9.5 log10 cfu of the strain.', 'armGroupLabels': ['Probiotic group']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral administration of a capsule containing maltodextrin.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18004', 'city': 'Granada', 'country': 'Spain', 'facility': 'Biosearch S.A.U.', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Universidad Complutense de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Juan M. Rodríguez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Complutense University Madrid'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'All the raw data will be available to other researchers once the study is published.', 'ipdSharing': 'YES', 'description': 'Global and individual reproductive rates, microbiological and immunological data will be available to other researchers once the study (including analyses of all the samples) is completed and published.', 'accessCriteria': 'Our intention is that all the raw data will be available as a supplementary tables in an open acess journal. They will be also provided on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosearch S.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital San Carlos, Madrid', 'class': 'OTHER'}, {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}