[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100202481":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":30,"responsibleParty":47,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":33,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"KU Leuven","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Rectal biopsy","EXPERIMENTAL",null,[13],"Procedure: Rectal biopsies from IBS patients or healthy subjects will be taken during proctoscopy",[15],{"type":16,"name":17,"description":11,"armGroupLabels":18,"otherNames":11},"PROCEDURE","Rectal biopsies from IBS patients or healthy subjects will be taken during proctoscopy",[9],[20],{"name":21,"affiliation":22,"role":23},"Guy Boeckxstaens, MD","Catholic University Leuven and Universitary Hospitals Leuven","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Koen Bellens, MSc","CONTACT","0032-16-341943","koen.bellens@kuleuven.be",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"University Hospitals Leuven","RECRUITING","Leuven","Vlaams-Brabant","3000","Belgium","BE",{"type":40,"coordinates":41},"Point",[42,43],4.70093,50.87959,{"lat":43,"lon":42},[46],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},{"type":23,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Guy Boeckxstaens","Prof. Dr.","100202481","measuring-nerve-activity-in-small-human-intestinal-biopsies-in-ibs-irritable-bowel-syndrome-100202481",false,"NCT01912313","Measuring Nerve Activity in Small Human Intestinal Biopsies in IBS (Irritable Bowel Syndrome)","Inclusion Criteria:\n\n* IBS patients (based on ROME III Criteria)\n* Healthy subjects\n\nExclusion Criteria:\n\n\\- All subjects with not IBS related complaints",true,"ALL","18 Years","99 Years",{"count":61,"type":62},99999999,"ESTIMATED","INTERVENTIONAL",[65],"NA","Rectal biopsies from IBS patients or healthy subjects will be taken.\n\nBiopsies will be used for:\n\n1. the isolation of submucosal plexus to perform: 1.1 live nerve recordings and Calcium imaging; 1.2 immunohistochemistry; 1.3 mRNA (Messenger ribonucleic acids) isolation and real time PCR (Polymerase chain reaction);\n2. culturing biopsies\n\nOn the basis of these observations, the general aim of the study is to move a significant step forward in the current knowledge on human ENS (enteric nervous system) in IBS by establishing a live imaging method to record enteric nerves activity in small intestinal biopsies from humans. This development is unique in its kind as not other research groups have reported successful live recordings with calcium imaging in this preparation.\n\nIn particular, the investigators aim:\n\n1. to develop and validate the technique to measure activity in human enteric nerves in the submucous plexus isolated from rectal biopsies from healthy subjects and IBS patients;\n2. to characterize this nerve activity in healthy subjects and IBS patients using both calcium imaging to evaluate the effect of different neuromodulators, immunohistochemistry and rtPCR to determine receptor expression levels and identify neurons and glial cells in the submucous ganglia;\n3. to investigate whether the biopsies of IBS patients secrete more modulators\u002Fcytokines compared to healthy subjects and their potential to activate neurons.\n4. to evaluate the influence of different food constituents (cow\"s milk, wheat, yeast, gluten and soy) on the local reaction of the rectal mucosa and evaluate mast cell activation\u002Fdegranulation in biopsies of IBS patients compared to healthy subjects.\n5. To evaluate the amount of inflammatory mediators\u002Fmetabolites in urine samples of IBS patients and healthy volunteers by the use of metabolic profiling",[68,69],"IBS","Healthy",[71,72],"IBS patients","healthy subjects","2026-03-19",{"date":75,"type":76},"2026-03-20","ACTUAL",{"date":78,"type":11},"2013-08",{"date":80,"type":62},"2026-12",{"name":5,"class":6},1]