[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640097":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":63,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":25,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Sahlgrenska University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Adults with IBS who have been randomized to receive the intervention",[13],"Other: Probiotic Supplementation (Lactobacillus Reuteri)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","PLACEBO_COMPARATOR","Adults with IBS who have been randomized to receive the placebo",[19],"Other: Placebo Supplementation",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Probiotic Supplementation (Lactobacillus Reuteri)","Probiotic using a new strain derived from L. reuteri.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo Supplementation","A placebo supplement that is identical to the probiotic in formulation and packaging except that the probiotic bacteria is not present.",[15],[31],{"name":32,"affiliation":33,"role":34},"Magnus Simren, MD PHD","Göteborg University","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Magnus Simren, MD, PhD","CONTACT","0046313428107","magnus.simren@medicine.gu.se",{"name":42,"role":38,"phone":39,"phoneExt":25,"email":43},"MagTarmlab office","magtarmlab.su@vgregion.se",[45],{"facility":46,"status":47,"city":48,"state":25,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Mag-tarmlab, Sahlgrenska University Hospital","RECRUITING","Gothenburg","413 45","Sweden","SE",{"type":53,"coordinates":54},"Point",[55,56],11.96679,57.70716,{"lat":56,"lon":55},[59],{"name":60,"role":38,"phone":61,"phoneExt":25,"email":62},"MagTarmlab","+46 31 342 81 07","magtarmlab.se@vgregion.se",{"type":34,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Magnus Simrén","Professor","100640097","probiotics-and-biomarkers-in-irritable-bowel-syndrome-100640097",false,"NCT07584278","Probiotics and Biomarkers in Irritable Bowel Syndrome","The Impact of Probiotics on Biomarkers and Symptom Severity in Irritable Bowel Syndrome","BIO-IBS","Inclusion Criteria:\n\n* Diagnosed with IBS according to ROME V criteria\n* IBS-SSS greater than or equal to 75\n* Adult over 18 years old\n* BMI 18.5-35 kg\u002Fm2\n* Able to understand the participant information sheet and willing to comply with the study protocol\n* Able to give informed consent\n* Able to complete the Swedish questionnaires\n\nExclusion Criteria:\n\n* History of any gastroenterology disease including coeliac disease, heart, liver, neurological, or current psychiatric disease, diabetes, any surgery to the abdomen that affects intestinal function (not including cholecystectomy, appendectomy, ceasarean section).\n* The use of opioids 1 month prior to screening and throughout the study\n* The use of probiotic supplements from 14days before randomization and during the study (not including foods with probiotic components)\n* Consumption of antibiotics 3 months prior to screening and throughout the study\n* The start of any new drugs that affect the gastrointestinal tract or symptoms within the last month before the start of the study. As well as the start of new diets of psychological therapy as treatment for IBS symptoms.\n* Participation in any medical research during the last month\n* Clinically relevant lab abnormalities at the time of screening (fecal calprotectin greater than or equal to 150 ug\u002Fg as absolute cutoff. If calprotectin is between 50 - 150ug\u002Fg the decision is made on clinical judgement)\n* Pregnancy, plan to become pregnant during the study, breastfeeding\n* alcohol consumption \\>14 units per week\n* Use of recreational active drugs during 1 month before screening or during the study\n* Use of medication that primarily affects bowel function, transit time, stool consistency 2 weeks before the intervention or during the 12 week intervention period","ALL","18 Years",{"count":77,"type":78},252,"ESTIMATED","INTERVENTIONAL",[81],"NA","The goal of this double-blind parallel-arm randomized controlled trial is to learn if a probiotic supplement (containing a new strain derived from L. reuteri) alters outcomes related to symptom severity and transit time in adults with irritable bowel syndrome (IBS). The main question it aims to answer is:\n\nDoes the probiotic alter IBS symptom severity?\n\nResearchers will compare the probiotic to a placebo (a lookalike substance that contains no probiotic) to see if the probiotic works to alter outcomes.\n\nParticipants will:\n\nBe randomized to either take the probiotic supplement or placebo supplement daily for 12 weeks.\n\nVisit the lab for 4 study visits (visit 1: screening and informed consent; visit 2: randomization, data collection, beginning the intervention; visit 3: end of intervention and data collection; visit 4: 3 month post intervention follow up and data collection).\n\nProvide biological samples (blood, stool, saliva, urine) Complete questionnaires",[84],"Irritable Bowel Syndrome (IBS)",[86,87,88,89,90],"probiotic","irritable bowel syndome","ibs symptom severity","oro-anal transit time","randomized controlled trial","2026-05-27",{"date":93,"type":94},"2026-06-01","ACTUAL",{"date":96,"type":94},"2026-04-28",{"date":98,"type":78},"2031-05",{"name":5,"class":6},1]