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

NCT07716553 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-30

No results posted yet for this 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.

Conditions

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

  • Azienda Policlinico Umberto I

    collaborator OTHER

  • Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine

    collaborator UNKNOWN

  • ISS Istituto per la Sicurezza Sociale, San Marino

    collaborator UNKNOWN

  • Hospital of Prato

    collaborator OTHER

  • University Hospital of Ferrara

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-09-30
Completion
2029-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07716553 on ClinicalTrials.gov