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

NCT07716553 · tracked via the Priya Life Science Italy tracker

Sponsor

University Hospital of Ferrara

Phase

Not applicable

Started

2026-09-30

Last updated

2026-07-30

Condition(s) studied

Parkinson DiseaseConstipation

Investigational drug(s) / intervention(s)

Transanal Irrigation SystemStandard Bowel Care

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.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * For inclusion in the study, subjects must fulfil all of the following criteria: 1. Provision of informed consent. 2. Female or male aged 18 years or above. 3. Established diagnosis of PD according to MDS criteria 4. Patients with bowel symptoms post-dating and related to a diagnosis of PD. 5. PD patients suffering from constipation defined by Cleveland Clinic (Wexner) constipation score ≥10 confirmed at Baseline. 6. Only TAI treatment naïve patient (not having previously used any particular TAI system). 7. Judged eligible for TAI as per standardized treatment pathway . 8. Able to read, write and understand information given to them regarding the study. Exclusion Criteria Any of the following is regarded as a criterion for exclusion from the study: * 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. * Antibiotic therapy in the past 3 weeks. * Performed endoscopic polypectomy within 4 weeks prior enrolment. * Ongoing, confirmed pregnancy or lactation. * Any neuromodulation that can affect the pelvic organ function. * Current treatment of prokinetics. * Any other condition, as judged by the investigator, might make follow-up or investigations inappropriate. Exclusion Criteria: \-

Primary outcome measure(s)

Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score) — Baseline, 6 months, and 24 months.
Constipation severity will be assessed using the Cleveland Clinic Constipation Score (Wexner Constipation Score). The score ranges from 0 to 30, where higher scores indicate more severe constipation. The outcome measure will be the change from baseline in total score at each assessment.

Trial sites (1)

Facility	City	Region	Status
University Hospital Ferrara	Ferrara	Ferrara

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07716553 on ClinicalTrials.gov ↗ ← All trials in Italy