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Could a simple bowel rinse ease Parkinson's constipation and movement problems?

NCT ID NCT07716553

Symptom relief Sponsor: University Hospital of Ferrara Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This study compares transanal irrigation (using a device to rinse the bowel) against standard care (diet, fluids, laxatives) for treating severe constipation in people with Parkinson's disease. Researchers will also check if the treatment affects gut bacteria and motor symptoms. Two hundred participants will be randomly assigned to one of the two approaches and followed for up to 24 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a transanal irrigation system (Qufora Flow device) for bowel management
What this could lead to
If effective, transanal irrigation could offer a non-drug option to manage severe constipation in Parkinson's disease, potentially improving quality of life and easing motor symptoms.
What could go wrong
This is a relatively small trial (200 people) and the device requires regular self-use, which may not suit everyone. Benefits for motor symptoms or microbiome changes are exploratory and uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: \-

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Conditions

The condition(s) this trial relates to.

constipation disorder Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Constipation Parkinson disease

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University Hospital Ferrara

    Ferrara, Ferrara, 44100, Italy

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