Study of Transanal Irrigation vs Standard Care for Constipation, Gut Microbiota, and Motor Disorders in Parkinson's Disease

Sponsor
University Hospital of Ferrara
Study ID
NCT07716553
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transanal Irrigation System — DEVICE
    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 — OTHER
    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.

Study Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Transanal Irrigation (TAI) with Qufora Flow Device
    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.
  • Active Comparator: Standard Bowel Care (SBC)
    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.

Primary Outcome Measure

Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score) [ Time Frame: Baseline, 6 months, and 24 months. ]

Central Contacts

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