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

Starting soon · Not applicable

Conditions studied: Parkinson Disease, Constipation

In brief

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 facts

Study ID

NCT07716553

Run by

University Hospital of Ferrara

People needed

200

Starts

2026-09-30

Expected to finish

2029-09-30

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• For inclusion in the study, subjects must fulfil all of the following 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 .
• Able to read, write and understand information given to them regarding the study.

You may not qualify if…

• 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:

Where it is running

• University Hospital Ferrara — Ferrara, Ferrara, Italy

Full record on ClinicalTrials.gov

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