[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ProbiSearch SL\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":5},"100525474","effect-of-a-probiotic-on-the-female-genital-tract-microbiota-of-participants-with-fertility-disorders-100525474",false,"NCT06122207","Effect of a Probiotic on the Female Genital Tract Microbiota of Participants With Fertility Disorders.","A Randomized, Double-blind, Placebo-controlled Study to Confirm the Positive Effect of Fertibiome® (Ligilactobacillus Salivarius PS11610) on the Female Genital Tract Microbiota of Couples or Women With Fertility Disorders.","PROFEC II","Inclusion Criteria:\n\n* Couples or women with ages between 18 and 45 for woman and between 18 and 55 for man (in case of couple participation).\n* Couples or women with fertility disorders.\n* Couples or women undergoing IVF treatment or willing to start it.\n* Signature of the Informed Consent.\n\nExclusion Criteria:\n\n* Women, not participating in the study with a couple, who have not undergone at least 4 cycles of artificial insemination with donor's sperm (AID) or 1 cycle of IVF without achieving evolutionary pregnancy.\n* Women with Body Mass Index (BMI) ≥ 30.\n* Couples where the woman has not infertility diagnosis while the man has any of the following characteristics:\n\n  * Azoospermia\n  * Sperm motility (A + B) \\\u003C 25%.\n  * Sperm morphology ≤ 2%.\n  * Vas deferens obstruction.\n* Couples or women with any of the following characteristics:\n\n  * Chronic diseases that cause intestinal malabsortion.\n  * Congenital or acquired immunodeficiency.\n  * Current history or diagnosis of alcohol, tobacco, or drug abuse.\n  * Uncertainty about the willingness or ability of participants to comply with the requirements of the protocol.\n  * Under treatment with probiotics during the last week.","ALL","18 Years","45 Years",{"count":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"NA","In the last decades, numerous publications have broken the old paradigm that considered the urogenital tracts as sterile, demonstrating that microorganisms present in the urogenital tract represent the 9% of the whole human microbiome. Healthy urogenital microbiome improves implantation rate and pregnancy outcomes, whereas 40% of dysbiosis prevalence is observed in women under assisted reproductive treatment (ART).\n\nInfertility causes are associated with male, female, or combined failure. It has been shown that oral probiotic treatment, mainly with Lactobacillus, recovers a healthy vaginal microbiota without safety concerns.\n\nAn interventional, randomized, double-blind, placebo-controlled study will be conducted to confirm the positive effect of the commercial probiotic product Fertibiome® on the vaginal dysbiosis of couples or women with fertility disorders.\n\nThe duration of the study will be of 6 months approximately, including 6 months of product intake. In case of pregnancy during intervention, women will continue their participation until week 12 of gestation.\n\nParticipants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group. Women will take 1 capsule every 12 hours and men 1 per day. In case of women participating alone they will take 1 capsule every 12 hours. In case of pregnancy, only women will continue taking 1 capsule per day for the first 12 weeks.",[28],"Fertility Disorders","RECRUITING","2026-04-07",{"date":32,"type":33},"2026-04-13","ACTUAL",{"date":35,"type":33},"2024-02-14",{"date":37,"type":22},"2027-03",{"name":39,"class":40},"ProbiSearch SL","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":64},"100543156","effect-of-probiotics-on-the-intestinal-microbiota-of-pediatric-patients-100543156","NCT06352203","Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients","Randomized, Double-blind, Placebo-controlled Study to Evaluate the Modulating Effect of Probiotics on the Intestinal Microbiota of Pediatric Patients With Neurodevelopmental Disorders.","Inclusion Criteria:\n\n* Children aged 3 to 7 years old.\n* Diagnosed with autism spectrum disorder, according to the clinical criteria of the \"Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)\" and who meet criteria for ASD according to the ADOS-2 classification.\n* Presenting one or more gastrointestinal symptoms (constipation, diarrhoea, abnormal stools, painful defecation, abdominal pain, reflux, bloating, flatulence).\n* Written informed consent signed by the parent or legal guardian with express or tacit consent of the other parent.\n\nExclusion Criteria:\n\n* With intake of antibiotics in the last month.\n* With intake of probiotics in the last two weeks.\n* Diagnosed with short bowel syndrome or has undergone relevant surgery on the gastrointestinal tract.\n* Exhibiting a defect in the intestinal epithelial barrier (e.g. inflammatory bowel disease (IBD)).\n* Diagnosed with endocrinological diseases such as diabetes mellitus, hypo- and hyperthyroidism, Cushing's disease, Addison's disease, etc.\n* Having heart failure and a cardiac medical history (e.g. artificial heart valve, medical history of infective endocarditis, rheumatic fever, or cardiac malformation).\n* Congenital or acquired immunodeficiency.\n* Immunocompromised (e.g., cancer and\u002For transplant patients taking certain immunosuppressive drugs, patients with inherited diseases that affect or may affect the immune system).\n* Uncertainty on the part of the investigator about the willingness or ability of the minor's parents or legal guardian to comply with the requirements of the protocol.\n* With oral hyper sensitivity impairments that prevent the uptake of the study product.","3 Years","7 Years",{"count":51,"type":22},60,[25],"Numerous studies have described an altered gut microbiota composition (dysbiosis) in patients with neurodevelopmental disorders that can be correlated with their symptoms, especially gastrointestinal symptoms.\n\nAn interventional, randomised, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic supplement on the microbiota composition of children aged 3-7 years with neurodevelopmental issues.\n\nThe duration of the study will be of 6 months approximately, including 6 months of product intake.\n\nParticipants will be randomly assigned to one of the two study groups: control group with placebo administration or probiotic administration group.",[55],"Neurodevelopmental Disorders","2026-02-24",{"date":58,"type":33},"2026-02-25",{"date":60,"type":33},"2024-04-12",{"date":62,"type":22},"2026-12",{"name":39,"class":40},1,""]