[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605918":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":11,"studyPopulation":11,"armGroups":36,"interventions":47,"overallOfficials":11,"centralContacts":11,"locations":55,"responsibleParty":75,"collaborators":11,"id":77,"slug":11,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":11,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Hospital Universitari Vall d'Hebron Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Increase in the percentage of Treg cells",null,"6 months",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Immunological profile (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs","Immunological profile studied by flow cytometry (percentage of positive cells): Th1 cells; Th17cells; Breg cells; DCs.",{"measure":18,"description":19,"timeFrame":12},"Serum levels of NfL, GFAP, cytokines and CRP","Serum levels of NfL and GFAP quantified using a commercially available ultra-sensitive single molecule enzyme-linked immunoarray (SIMOA, Quanterix).",{"measure":21,"description":22,"timeFrame":12},"Serum and fecal levels of SCFAs","Serum and fecal levels of SCFAs analyzed using a liquid chromatography tandem mass spectrometry (LC-MS\u002FMS) system.",{"measure":24,"description":25,"timeFrame":12},"Microbiota composition analysis","Bioinformatic analysis of the microbiome by the analysis of the total DNA extraction and sequencing of fecal samples and negative control sample.",{"allocation":27,"interventionModel":28,"interventionModelDescription":11,"primaryPurpose":29,"observationalModel":11,"timePerspective":11,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":11,"whoMasked":32},"TRIPLE",[33,34,35],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[37,42],{"label":38,"type":39,"description":11,"interventionNames":40},"Lactibane Iki","EXPERIMENTAL",[41],"Dietary Supplement: Lactibane Iki",{"label":43,"type":44,"description":11,"interventionNames":45},"Placebo","PLACEBO_COMPARATOR",[46],"Other: Placebo",[48,52],{"type":49,"name":38,"description":50,"armGroupLabels":51,"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.",[38],{"type":6,"name":43,"description":53,"armGroupLabels":54,"otherNames":11},"Patients will receive a placebo (starch) sachet twice a day for six months.",[43],[56],{"facility":57,"status":58,"city":59,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Centre d'Esclerosi Mútiple de Catalunya (Cemcat)","RECRUITING","Barcelona","08035","Spain","ES",{"type":64,"coordinates":65},"Point",[66,67],2.15899,41.38879,{"lat":67,"lon":66},[70],{"name":71,"role":72,"phone":73,"phoneExt":11,"email":74},"Carmen Espejo","CONTACT","+34 93 7372476","carmen.espejo@vhir.org",{"type":76,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":88,"type":89},80,"ESTIMATED","INTERVENTIONAL",[92],"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.",[95],"Multiple Sclerosis","2025-09-22",{"date":98,"type":99},"2025-09-23","ACTUAL",{"date":101,"type":99},"2025-07-10",{"date":103,"type":89},"2027-12-31",{"name":5,"class":6},1]