NCT07716553Not yet recruiting
Study of Transanal Irrigation vs Standard Care for Constipation, Gut Microbiota, and Motor Disorders in Parkinson's Disease
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.
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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 (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 3 Jul 2026
- Start date
- 30 Sept 2026
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- University Hospital of Ferrara
- Diseases
- Parkinson disease
- NCT number
- NCT07716553
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 30 Sept 2026 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Opioid consumption ≤24 hours prior enrolment.
- Antibiotic therapy in the past 3 weeks.
- Performed endoscopic polypectomy within 4 weeks prior enrolment.
Other illness
- 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).
- Any other condition, as judged by the investigator, might make follow-up or investigations inappropriate.
Other
- Any of the following is regarded as a criterion for exclusion from the study:
- Taking probiotics in the past 30 days.
- Ongoing, confirmed pregnancy or lactation.
- Any neuromodulation that can affect the pelvic organ function.
- Current treatment of prokinetics.
- \-
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.