Study of Transanal Irrigation vs Standard Care for Constipation, Gut Microbiota, and Motor Disord… (NCT07716553) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study of Transanal Irrigation vs Standard Care for Constipation, Gut Microbiota, and Motor Disorders in Parkinson's Disease
Italy200 participantsStarted 2026-09-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. PD patients suffering from constipation defined by Cleveland Clinic (Wexner) constipation score ≥10 confirmed at Baseline.
. Only TAI treatment naïve patient (not having previously used any particular TAI system).
. Judged eligible for TAI as per standardized treatment pathway .
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing transanal irrigation — which involves flushing the lower bowel with water — as a treatment for constipation in Parkinson's disease. Can you explain what that procedure actually involves day-to-day, and whether my current motor symptoms would make it physically manageable for me?
2The trial is listed as 'not yet recruiting,' which means it hasn't started enrolling patients yet. Do you know when it might open, and is there anything I should be doing now to manage my constipation while I wait to see if I'd be a candidate?
3The study is measuring improvement using something called the Cleveland Clinic Constipation Score (Wexner Score). Can you walk me through what that scale actually measures, and how my current constipation severity would compare to what this trial seems to be targeting?
4Since this trial is Phase NA — meaning it may be more exploratory in nature — how much is already known about the safety and effectiveness of transanal irrigation specifically for people with Parkinson's disease, versus standard care options I could try right now?
5The trial also seems to be looking at gut microbiota alongside constipation and motor symptoms. Does the current evidence suggest that treating constipation in Parkinson's patients might have any meaningful effect on motor symptoms, and is that something worth factoring into my overall treatment plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score)