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Study of Transanal Irrigation vs Standard Care for Constipation, Gut Microbiota, and Motor Disorders in Parkinson's Disease
Sponsor: University Hospital of Ferrara
Summary
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-09-30
Completion Date
2029-09-30
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (1)
University Hospital Ferrara
Ferrara, Ferrara, Italy