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

NCT07716553

Not Yet RecruitingNA

Sponsor: University Hospital of Ferrara

Conditions: Parkinson Disease, Constipation

Interventions: Transanal Irrigation System, Standard Bowel Care

Countries: Italy

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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:

Locations (1)

Ferrara, Ferrara, Italy