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.
The 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.
Participants 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.
Provision of informed consent.
Female or male aged 18 years or above.
Established diagnosis of PD according to MDS criteria
Patients with bowel symptoms post-dating and related to a diagnosis of PD.
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.
Other significant neurological diseases (defined as all neurological diseases except for minor functional neurological syndromes or non-PD related neuro complications).
Opioid consumption ≤24 hours prior enrolment.
Taking probiotics in the past 30 days.
University Hospital of Ferrara
Lead sponsor
Azienda Policlinico Umberto I
Collaborator
Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine
Collaborator
ISS Istituto per la Sicurezza Sociale, San Marino
Collaborator
Hospital of Prato
Collaborator