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

July 15, 2026 updated by: Simona Ascanelli, University Hospital of Ferrara

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.

The goal of this study is to learn if transanal irrigation (TAI) works better than standard bowel care (SBC) to treat severe constipation in people with Parkinson's disease (PD). It will also evaluate its effects on gut microbiota and motor disorders, as well as its safety.

The main questions it aims to answer are:

Does TAI improve constipation more than standard bowel care? Does TAI have an effect on gut microbiota composition? Does TAI influence motor and non-motor symptoms in Parkinson's disease? What side effects or safety issues occur with TAI?

Researchers will compare TAI using the Qufora Flow device to standard bowel care (including diet, fluids, and medications) to see which approach is more effective.

Participants will:

Be randomly assigned to TAI or standard bowel care Perform TAI every other day or follow standard bowel care routines Attend clinic visits at the start, after 6 months, and after 24 months Receive follow-up phone calls after 1 month and 12 months Complete questionnaires on bowel function, quality of life, and Parkinson's symptoms Provide stool samples to analyze gut microbiota Keep a food diary and record treatments

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of the study is to evaluate the efficacy of transanal irrigation (TAI) compared to standard bowel care (SBC) in the treatment of constipation associated with Parkinson's disease, measured by the change in the Cleveland Clinic (Wexner) constipation score in the short term (6 months) and long term (24 months).

Secondary objectives are:

to evaluate quality of life related to bowel symptoms after 6 and 24 months of TAI treatment compared to SBC (change in PACQoL score from baseline to 6 and 24 months in the TAI arm vs SBC arm); to evaluate changes in bowel symptoms (constipation and fecal incontinence) after 6 and 24 months of TAI vs SBC (change in Neurogenic Bowel Dysfunction (NBD) Score from baseline to 6 and 24 months in TAI arm vs SBC arm); to evaluate fecal incontinence after 6 and 24 months of TAI vs SBC (change in Fecal Incontinence Cleveland Clinic Index - FI-CCI); to evaluate patient satisfaction with treatment and bowel management after 6 and 24 months of TAI vs SBC (using a VAS scale); to evaluate treatment adherence after 6 and 24 months (number of subjects using TAI or SBC); to evaluate the association between gut microbiota composition (GM) in PD patients using TAI vs controls at 6 and 24 months; to evaluate the association between motor and non-motor symptoms and their correlation with dopaminergic therapy (Hoehn and Yahr, UPDRS, MoCA, NMSS, SCOPA-AUT, PDQ-39, LEDD); to evaluate safety through adverse events and device deficiencies.

Study duration: approximately 3 years (12-month recruitment).

Inclusion criteria:

informed consent signed age ≥18 years confirmed PD diagnosis (Movement Disorder Society (MDS) clinical diagnostic criteria.) bowel symptoms after PD diagnosis severe constipation (Wexner score ≥10) no prior TAI use eligible for TAI able to understand study information

Exclusion criteria:

anorectal stenosis active inflammatory bowel disease severe diverticulosis/diverticulitis colorectal cancer ischemic colitis autonomic dysreflexia bleeding disorders unspecified perianal conditions other major neurological diseases recent opioid, probiotic, or antibiotic use recent polypectomy pregnancy/breastfeeding neuromodulation affecting pelvic organs ongoing prokinetic therapy likely protocol non-compliance

Sample size: 94 patients (47 TAI, 47 SBC).

Study design: multicenter randomized controlled trial (11 centers).

Patients will be screened, consented, and randomized 1:1 to TAI or SBC.

Fecal samples will be collected, stored at -80°C, and analyzed in Cesena (Italy). Data will be anonymized.

TAI treatment:

Performed using Qufora Flow device. Water (400 ml) is introduced rectally to stimulate evacuation. Procedure lasts ~20 minutes, every other day.

SBC treatment:

Includes diet, fluids, physical activity, abdominal massage, laxatives, and rectal stimulation.

Follow-up:

3 in-person visits (baseline, 6, 24 months) + 2 phone follow-ups (1 and 12 months).

Consent and ethics:

Information provided before consent; participation voluntary; withdrawal allowed at any time.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Ferrara
      • Ferrara, Ferrara, Italy, 44100
        • University Hospital Ferrara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transanal Irrigation (TAI) with Qufora Flow Device
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
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.
Active Comparator: Standard Bowel Care (SBC)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Cleveland Clinic Constipation Score (Wexner Constipation Score)
Time Frame: 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.
Baseline, 6 months, and 24 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Patient Assessment of Constipation Quality of Life (PAC-QOL) Total Score
Time Frame: Baseline, 6 months, and 24 months.
Quality of life related to constipation will be assessed using the Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire. The total score ranges from 0 to 4, with higher scores indicating poorer constipation-related quality of life. The outcome measure will be the change from baseline in total score.
Baseline, 6 months, and 24 months.
Change From Baseline in Neurogenic Bowel Dysfunction (NBD) Score
Time Frame: Baseline, 6 months, and 24 months.
Bowel dysfunction severity will be assessed using the Neurogenic Bowel Dysfunction (NBD) Score. The score ranges from 0 to 47, with higher scores indicating more severe bowel dysfunction. The outcome measure will be the change from baseline in total score.
Baseline, 6 months, and 24 months.
Change From Baseline in Cleveland Clinic Fecal Incontinence Score (Wexner Fecal Incontinence Score)
Time Frame: Baseline, 6 months, and 24 months.
Fecal incontinence severity will be assessed using the Cleveland Clinic Fecal Incontinence Score (Wexner Fecal Incontinence Score). The score ranges from 0 to 20, with higher scores indicating more severe fecal incontinence. The outcome measure will be the change from baseline in total score.
Baseline, 6 months, and 24 months.
Change From Baseline in Treatment Satisfaction Measured by Visual Analog Scale (VAS)
Time Frame: Baseline, 6 months, and 24 months.
Patient satisfaction with bowel management and study treatment will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where higher scores indicate greater satisfaction. The outcome measure will be the change from baseline.
Baseline, 6 months, and 24 months.
Treatment Adherence
Time Frame: Baseline, 6 months, and 24 months.
Treatment adherence will be assessed as the number and percentage of participants remaining on the assigned study treatment (TAI or standard bowel care) at each follow-up visit.
Baseline, 6 months, and 24 months.
Change From Baseline in Hoehn and Yahr Stage
Time Frame: Baseline, 6 months, and 24 months.
Disease severity will be assessed using the Hoehn and Yahr staging scale. The scale ranges from Stage 1 to Stage 5, with higher stages indicating more advanced Parkinson's disease. The outcome measure will be the change from baseline in disease stage.
Baseline, 6 months, and 24 months.
Number of Participants With Adverse Events, Serious Adverse Events, and Device Deficiencies
Time Frame: From randomization until 24 months.
Safety will be assessed by recording the number of participants experiencing adverse events (AEs), serious adverse events (SAEs), and device deficiencies during the study period.
From randomization until 24 months.
Change in Gut Microbiota Composition
Time Frame: Baseline, 6 months, and 24 months
Gut microbiota composition will be assessed from stool samples using microbiological sequencing analysis. Changes in microbial composition and diversity from baseline will be compared between treatment groups.
Baseline, 6 months, and 24 months
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score
Time Frame: Baseline, 6 months, and 24 months.
Motor and non-motor symptoms will be assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The total score ranges from 0 to 272, with higher scores indicating greater severity of Parkinson's disease symptoms. The outcome measure will be the change from baseline in the total score.
Baseline, 6 months, and 24 months.
Change From Baseline in Montreal Cognitive Assessment (MoCA) Score
Time Frame: Baseline, 6 months, and 24 months.
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The score ranges from 0 to 30, with higher scores indicating better cognitive function. The outcome measure will be the change from baseline in total score.
Baseline, 6 months, and 24 months.
Change From Baseline in Non-Motor Symptoms Scale (NMSS) Total Score
Time Frame: Baseline, 6 months, and 24 months.
Non-motor symptoms will be assessed using the Non-Motor Symptoms Scale (NMSS). The total score ranges from 0 to 360, with higher scores indicating a greater burden of non-motor symptoms. The outcome measure will be the change from baseline in total score.
Baseline, 6 months, and 24 months.
Change From Baseline in SCOPA-AUT Total Score
Time Frame: Baseline, 6 months, and 24 months.
Autonomic symptoms will be assessed using the Scale for Outcomes in Parkinson's Disease for Autonomic Symptoms (SCOPA-AUT). The total score ranges from 0 to 69, with higher scores indicating more severe autonomic dysfunction. The outcome measure will be the change from baseline in total score.
Baseline, 6 months, and 24 months.
Change From Baseline in Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
Time Frame: Baseline, 6 months, and 24 months.
Health-related quality of life will be assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39). The Summary Index ranges from 0 to 100, with higher scores indicating poorer quality of life. The outcome measure will be the change from baseline in the Summary Index.
Baseline, 6 months, and 24 months.
Change From Baseline in Levodopa Equivalent Daily Dose (LEDD)
Time Frame: Baseline, 6 months, and 24 months.
The Levodopa Equivalent Daily Dose (LEDD), expressed in milligrams per day (mg/day), will be recorded to assess changes in dopaminergic therapy during the study. The outcome measure will be the change from baseline in LEDD.
Baseline, 6 months, and 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Ferrara

Collaborators

Hospital of Prato
Azienda Policlinico Umberto I
Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine
ISS Istituto per la Sicurezza Sociale, San Marino

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

July 3, 2026

First Submitted That Met QC Criteria

July 15, 2026

First Posted (Actual)

July 21, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 187/2025/Disp/AOUFe

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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