[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582977":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":63,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":26,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Swiss Paraplegic Research, Nottwil","NETWORK",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Probiotic intervention","EXPERIMENTAL","Probiotics add beneficial bacterial strains to the gut, which can restore microbial balance.",[13],"Dietary Supplement: Probiotic",{"label":15,"type":16,"description":17,"interventionNames":18},"Prebiotic intervention","ACTIVE_COMPARATOR","Prebiotics, such as oat bran, selectively promote the growth of beneficial gut bacteria, particularly butyrate-producing species.",[19],"Dietary Supplement: Prebiotic",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Probiotic","Participants will take one sachet BIOTICS-G (Burgerstein, Switzerland, 2.5 g) daily for eight weeks. The supplement contains 14 bacterial strains with a total viable cell count of 2.5 billion colony-forming units per sachet.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Prebiotic","Participants will take 5 g of oat bran (Naturaplan Bio Haferkleie, Coop, Switzerland) daily for eight weeks.",[15],[32],{"name":33,"affiliation":5,"role":34},"Jivko Stoyanov, Prof. Dr.","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Claudio Perret, Prof. Dr.","CONTACT","+41419396650","claudio.perret@paraplegie.ch",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Anneke Hertig-Godeschalk, PhD","+41419396603","anneke.hertig@paraplegie.ch",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Swiss Paraplegic Research","RECRUITING","Nottwil","Canton of Lucerne","6207","Switzerland","CH",{"type":55,"coordinates":56},"Point",[57,58],8.13774,47.13469,{"lat":58,"lon":57},[61],{"name":62,"role":38,"phone":43,"phoneExt":26,"email":44},"Anneke Hertig, PhD",{"type":64,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100582977","the-effect-of-probiotic-and-prebiotic-supplementation-on-gastrointestinal-health-in-individuals-with-chronic-spinal-cord-injury-100582977",false,"NCT06870331","The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury","The Effect of Probiotic and Prebiotic Supplementation on Gastrointestinal Health in Individuals With Chronic Spinal Cord Injury: A Randomized Controlled Crossover Trial","PRO-GIDSCI","Inclusion Criteria (at screening):\n\n* Age: ≥ 18 years\n* Sex: male and female.\n* Chronic SCI (\\>1 year post-injury)\n* Individuals with para- and tetraplegia (American Spinal Cord Injury (ASIA) Impairment Scale (AIS) score A-D)\n* Having significant gastrointestinal complaints, indicated with \"yes\" at screening and by a GIQLI questionnaire score below 110 at baseline\n* Signed written informed consent\n\nExclusion Criteria (at screening):\n\n* Antibiotic use within the last four weeks before starting the study\n* Major dietary changes within the last four weeks before starting the study, such as initiating a vegan or ketogenic diet\n* Presence of clinically relevant medical conditions, including Crohn's disease, diagnosed eating or gastrointestinal disorders, assessed on an individual basis\n* Intake of significant concomitant medication, including immunomodulating therapy, mesalazines, or steroids, assessed on an individual basis\n* Concurrent participation in other clinical trials investigating or potentially affecting GI health\n* Insufficient German language skills to follow the study procedures\n* Pregnancy (anamnestic)","ALL","18 Years",{"count":76,"type":77},50,"ESTIMATED","INTERVENTIONAL",[80],"NA","The goal of this clinical trial is to evaluate the effect of probiotic and prebiotic supplementation in individuals with chronic spinal cord injury experiencing gastrointestinal complaints.\n\nThe main questions this trail aims to answer are:\n\n* what are the effects of the supplementation on gastrointestinal symptoms?\n* what are the effects of the supplementation on gut microbiome composition?\n* what are the effects of the supplementation on inflammatory serum markers?\n* what are the effects of the supplementation on gastrointestinal transit time?\n\nParticipants will:\n\n* take either the probiotic or prebiotic supplement daily for eight weeks, followed by a four-week \"wash-out period\" (= no intake of either supplement) and a subsequent eight-week intake of the other supplement.\n* visit the study center for four appointments, during which various measurements will be performed.",[83],"Spinal Cord Injury",[85,86,87,88,89],"probiotic","prebiotic","gastrointestinal health","microbiome","dietary supplement","2025-10-02",{"date":92,"type":93},"2025-10-03","ACTUAL",{"date":95,"type":93},"2025-08-11",{"date":97,"type":77},"2027-06",{"name":5,"class":6},1]