[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648163":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":50,"collaborators":54,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":89,"whyStopped":26,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"University Hospital of Ferrara","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transanal Irrigation (TAI) with Qufora Flow Device","EXPERIMENTAL","Participants randomized to this arm will receive transanal irrigation (TAI) using the Qufora Flow device. Subjects will be trained in proper device use after randomization. Treatment is administered as part of routine management of neurogenic bowel dysfunction in Parkinson's disease. Participants will attend scheduled on-site visits at Baseline, 6 months, and 24 months, and will complete telephone follow-ups at 1 month and 12 months.",[13],"Device: Transanal Irrigation System",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Bowel Care (SBC)","ACTIVE_COMPARATOR","Participants randomized to this arm will receive standard bowel care (SBC), including lifestyle advice and recommendations for laxative agents as clinically indicated. Subjects will have the same frequency of contact with the investigator or delegate as the experimental arm, including scheduled on-site visits at Baseline, 6 months, and 24 months, and telephone follow-ups at 1 month and 12 months.",[19],"Other: Standard Bowel Care",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Transanal Irrigation System","Transanal irrigation performed using a CE-marked transanal irrigation system (Irrisedo Flow, Qufora, Allerød, Denmark) for the management of neurogenic bowel dysfunction in patients with Parkinson's disease. Participants randomized to this arm will receive training on device use and will perform irrigation according to clinical practice and individual needs throughout the study period.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Standard Bowel Care","Standard bowel care including lifestyle advice (dietary and behavioral recommendations) and the use of laxative agents as clinically indicated. Participants will receive the same frequency of clinical follow-up as the experimental arm.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Simona Ascanelli, Medical Doctor","CONTACT","+39 0532 236316","simona.ascanelli@unife.it",[38],{"facility":39,"status":26,"city":40,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":26},"University Hospital Ferrara","Ferrara","44100","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],11.62057,44.83804,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Simona Ascanelli","General Surgeon",[55,57,60,62],{"name":56,"class":6},"Azienda Policlinico Umberto I",{"name":58,"class":59},"Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine","UNKNOWN",{"name":61,"class":59},"ISS Istituto per la Sicurezza Sociale, San Marino",{"name":63,"class":6},"Hospital of Prato","100648163","study-of-transanal-irrigation-vs-standard-care-for-constipation-gut-microbiota-and-motor-disorders-in-parkinsons-disease-100648163",false,"NCT07716553","Study of Transanal Irrigation vs Standard Care for Constipation, Gut Microbiota, and Motor Disorders in Parkinson's Disease","Trial Comparing the Efficacy of Transanal Irrigation Versus Standard Bowel Care in Patients With Parkinson's Disease and Severe Constipation. Impact on Gut Microbiome and Motor Disorders. TAI-PD Study.","TAI-PD","Inclusion Criteria:\n\n* For inclusion in the study, subjects must fulfil all of the following criteria:\n\n  1. Provision of informed consent.\n  2. Female or male aged 18 years or above.\n  3. Established diagnosis of PD according to MDS criteria\n  4. Patients with bowel symptoms post-dating and related to a diagnosis of PD.\n  5. PD patients suffering from constipation defined by Cleveland Clinic (Wexner) constipation score ≥10 confirmed at Baseline.\n  6. Only TAI treatment naïve patient (not having previously used any particular TAI system).\n  7. Judged eligible for TAI as per standardized treatment pathway .\n  8. Able to read, write and understand information given to them regarding the study.\n\nExclusion Criteria\n\nAny of the following is regarded as a criterion for exclusion from the study:\n\n* Any confirmed or suspected diagnosis of anal or colorectal stenosis, active inflammatory bowel disease, acute diverticulitis, severe diverticulosis, colorectal cancer, ischemic colitis, history of life-threatening autonomic dysreflexia, bleeding disorders, unspecified peri-anal conditions.\n* Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-PD related neuro complications).\n* Opioid consumption ≤24 hours prior enrolment.\n* Taking probiotics in the past 30 days.\n* Antibiotic therapy in the past 3 weeks.\n* Performed endoscopic polypectomy within 4 weeks prior enrolment.\n* Ongoing, confirmed pregnancy or lactation.\n* Any neuromodulation that can affect the pelvic organ function.\n* Current treatment of prokinetics.\n* Any other condition, as judged by the investigator, might make follow-up or investigations inappropriate.\n\nExclusion Criteria:\n\n\\-","ALL","18 Years",{"count":75,"type":76},200,"ESTIMATED","INTERVENTIONAL",[79],"NA","Constipation is one of the most common and disabling non-motor symptoms of Parkinson's disease (PD), often resulting in reduced quality of life and increased healthcare burden. Standard bowel care (SBC), including dietary modifications, fluid intake, physical activity, and laxative therapy, may not provide adequate symptom control in patients with severe constipation.\n\nThe purpose of this study is to evaluate whether transanal irrigation (TAI) using the Qufora Flow device is more effective than SBC in improving bowel function in patients with PD and severe constipation. In addition to bowel symptom improvement, the study will investigate the potential effects of TAI on gut microbiota composition, motor and non-motor symptoms of PD, treatment adherence, and safety.\n\nParticipants will be randomly assigned to receive either TAI or SBC and will be followed for 24 months. Clinical assessments, patient-reported outcome measures, and stool samples will be collected throughout the study to evaluate treatment effectiveness and to explore the relationship between bowel management, gut microbiota, and Parkinson's disease progression.",[82,83],"Parkinson Disease","Constipation",[85,83,86,87,88],"Parkinson","Transanal Irrigation","Gut Micriobiome","TAI","NOT_YET_RECRUITING","2026-07-28",{"date":92,"type":93},"2026-07-30","ACTUAL",{"date":95,"type":76},"2026-09-30",{"date":97,"type":76},"2029-09-30",{"name":5,"class":6},1]