Study of Transanal Irrigation vs Standard Care for Constipation, Gut Microbiota, and Motor Disorders in Parkinson's Disease | NCT07716553

NCT07716553

Overview

NCT ID: NCT07716553
Lead Sponsor: University Hospital of FerraraOTHER
Official Title: Trial Comparing the Efficacy of Transanal Irrigation Versus Standard Bowel Care in Patients With Parkinson's Disease and Severe Constipation. Impact on Gut Microbiome and Motor Disorders. TAI-PD Study.
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Sep 30, 2026Estimated
Primary Completion Date: Sep 30, 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

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:

-

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 200Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Contacts and Locations

Central Contacts: Simona Ascanelli, Medical DoctorContact
simona.ascanelli@unife.it+39 0532 236316

Similar Studies

Participant Group/Arms

Transanal Irrigation (TAI) with Qufora Flow DeviceExperimental

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.

Device: Transanal Irrigation System

Standard Bowel Care (SBC)Active Comparator

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.

Other: Standard Bowel Care