[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576480":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":30,"responsibleParty":45,"collaborators":11,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":51,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":11,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":11,"overallStatus":32,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Shaare Zedek Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Botulinum toxin","EXPERIMENTAL",null,[13],"Drug: Botulinum Toxin A (Botox )",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Botulinum Toxin A (Botox )","Botulinum Toxin injection",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Dotan Yogev, MD","CONTACT","97225645027","dotany@szmc.org",{"name":27,"role":23,"phone":28,"phoneExt":11,"email":29},"Zivia Shavit, MSc","972542520204","zivias@szmc.org.il",[31],{"facility":5,"status":32,"city":33,"state":11,"zip":11,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Jerusalem","Israel","IL",{"type":37,"coordinates":38},"Point",[39,40],35.21633,31.76904,{"lat":40,"lon":39},[43],{"name":44,"role":23,"phone":28,"phoneExt":11,"email":29},"Zivia Shavit",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Yogev Dotan","Dr Dotan Yogev","100576480","early-phase-1-intra-rectal-botulinum-toxin-injection-for-intractable-non-retentive-fecal-incontinence-in-children---an-open-label-pilot-study-100576480",false,"NCT06785844","Intra-rectal Botulinum Toxin Injection for Intractable Non-retentive Fecal Incontinence in Children - an Open Label Pilot Study","Inclusion Criteria:\n\n* Children 4-18 years old with fecal incontinence for a period greater than 6 months.\n* FI frequency of ≥ 3 episodes\u002Fweek.\n* After appropriate medical evaluation, FI cannot be explained by another medical condition.\n* Normal colonic transit study, defined as passage of 80% of markers on day\n* Normal RAIR on anorectal manometry\n\nExclusion Criteria:\n\n* Patients currently fulfilling rome IV criteria for functional constipation.\n* Patients with evidence of fecal retention.\n* Patients who had had good response to treatment for overflow incontinence.\n* Absent RAIR on anorectal manometry.\n* Any radiologic evidence of dochylosigmoid or distended colon.\n* Any known organic condition that may affect bowel transit.","ALL","4 Years","18 Years",{"count":59,"type":60},14,"ESTIMATED","INTERVENTIONAL",[63],"EARLY_PHASE1","Background: Fecal Incontinence (FI) is a frustrating and prevalent GI condition with profound social implications and a marked effect on quality of life. Treatment options are limited for children whose FI is not secondary to constipation (overflow incontinence), and they are defined as having non-retentive fecal incontinence (NRFI). Rectal botulinum injections (RBI) have recently shown promise for the treatment of FI in adults, following a large, randomized placebo-controlled trial, but no data exists regarding efficacy in children.\n\nObjectives: To evaluate the efficacy and safety of RBI in children with non-retentive fecal incontinence.\n\nMethods: A prospective open-label pilot study. Children with intractable NRFI will be screened using anorectal manometry and a colonic transit study. Eligible patients will receive one course of RBI and data regarding FI frequency will be prospectively collected during a 15-week period.\n\nSignificance: New treatment options for children with intractable fecal incontinence are highly in need. The current study aims to introduce a new treatment modality into pediatric research and patient care.",[66],"Fecal Incontinence","2026-06-17",{"date":69,"type":70},"2026-06-18","ACTUAL",{"date":72,"type":70},"2025-07-01",{"date":74,"type":60},"2030-09",{"name":5,"class":6},1]