[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605918":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":27,"responsibleParty":47,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":30,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Lactibane Iki","EXPERIMENTAL",null,[13],"Dietary Supplement: Lactibane Iki",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Other: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DIETARY_SUPPLEMENT","Patients will receive a probiotic sachet twice a day for six months. The probiotic, Lactibiane iki (Pileje; Paris, France), is composed of Bifidobacterium lactis LA 304, Lactobacillus acidophilus LA 201, and Lactobacillus salivarius LA 302 and contains 4x10E10 CFU\u002Fsachet.",[9],{"type":6,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Patients will receive a placebo (starch) sachet twice a day for six months.",[15],[28],{"facility":29,"status":30,"city":31,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Centre d'Esclerosi Mútiple de Catalunya (Cemcat)","RECRUITING","Barcelona","08035","Spain","ES",{"type":36,"coordinates":37},"Point",[38,39],2.15899,41.38879,{"lat":39,"lon":38},[42],{"name":43,"role":44,"phone":45,"phoneExt":11,"email":46},"Carmen Espejo","CONTACT","+34 93 7372476","carmen.espejo@vhir.org",{"type":48,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100605918","the-effect-of-a-probiotic-administration-as-an-add-on-treatment-in-multiple-sclerosis-100605918",false,"NCT07168772","The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis","The Effect of a Probiotic Administration as an add-on Treatment in Multiple Sclerosis: a Randomized, Double-blind, Placebo-controlled Clinical Trial","PROBiMS","Inclusion Criteria:\n\n* Patients aged 18-55 years, inclusive\n* Diagnosis of RRMS (McDonald Criteria 2017 and Lublin phenotype classification 2014)\n* Expanded disability status scale (EDSS) score less than or equal to 5.5\n* Patients receiving a first line treatment with teriflunomide or dimethyl fumarate at a stable dose, for at least 24 weeks, or patients who are not receiving treatment because they do not want to receive a DMT after the investigator has informed them of their possible respective benefits and possible adverse events\n* At enrollment, the patient is not expected to require a change in DMT\n* Patients showing a maximum of two new lesions on MRI prior to inclusion\n* Females of childbearing potential must have a negative urine pregnancy test result prior to initiation of study product\n* For females of childbearing potential: agreement to use adequate contraceptive methods during the treatment period\n* Ability to comply with the study protocol\n* Patients must sign and date a written informed consent prior to entering the study\n\nExclusion Criteria:\n\n* Relapse the month before enrollment\n* Presence of a new lesion, indicative of radiological activity, on the MRI performed before starting the study\n* Use of corticosteroids the month before enrollment\n* Use of antibiotics three months before enrollment\n* Taking other forms of symbiotic, probiotic, prebiotic and postbiotic supplements three months before enrollment\n* Patients suffering from any type of bowel disease\n* Pregnant or breastfeeding or intending to become pregnant during the study.\n* Be menopausal\n* Be a smoker","ALL","18 Years","55 Years",{"count":61,"type":62},80,"ESTIMATED","INTERVENTIONAL",[65],"NA","It is a randomized, double-blind, placebo-controlled clinical trial whose general objective of this study is to determine the effects of probiotic administration in multiple sclerosis patients.\n\n80 patients with relapsing-remitting multiple sclerosis will be enrolled in the study. Patients will be randomly assigned to receive either a probiotic (n=40) or a placebo (n=40) stratified by type of medication, gender and use of hormonal contraceptive treatment. They will receive a probiotic (Lactibane Iki) or placebo sachet twice a day for six months.",[68],"Multiple Sclerosis","2025-09-22",{"date":71,"type":72},"2025-09-23","ACTUAL",{"date":74,"type":72},"2025-07-10",{"date":76,"type":62},"2027-12-31",{"name":5,"class":6},1]