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Gut check: how Parkinson's affects digestion before treatment

NCT ID NCT07418658

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at gut changes in people with untreated Parkinson's disease compared to healthy adults. Researchers will measure gut permeability, microbiome, and transit time using stool samples, X-rays, and optional endoscopy. The goal is to better understand early gut involvement in Parkinson's, not to test a treatment.

What this could mean

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

What this could lead to
If successful, this study could reveal how the gut changes early in Parkinson's, pointing toward new ways to detect or understand the disease.
What could go wrong
This is an observational study with no treatment, so it won't directly help patients. It's small and early, so findings may not apply broadly.

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.

Participants

About 100 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Feb 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.

Who is studied

Patient participants will be recruited during patient consultations in the Movement Disorders Clinic of UZ Leuven. Neurologists in other hospitals may also be informed about the study, so that they may refer interested patients to UZ Leuven for potential participation in the study.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Patients eligible for inclusion in this study must meet all of the following criteria: 1. Diagnosis of Parkinson's Disease by a neurologist according to the Movement Disorder Society Clinical Diagnostic Criteria for PD 2. Signed informed consent form 3. Aged 18-75 years old 4. Able to understand the study and questionnaires, and comply with study requirements Controls eligible for inclusion in this study must meet all of the following criteria: 1. Aged 40-75 years old 2. Signed informed consent form 3. Able to understand the study and questionnaires, and comply with study requirements * Exclusion criteria: Participants eligible for this study must not meet any of the following criteria: Patients and controls: 1. Gastrointestinal: diagnosis of organic gastrointestinal diseases potentially affecting the assessments during the study (e.g. inflammatory bowel disease (IBD), celiac disease, eosinophilic diseases of the gastro-intestinal tract, gastro-intestinal cancer, diverticulitis in the last 6 months, GI infection in the last 3 months, …). 2. Surgery: major abdominal surgery (including, but not limited to: cholecystectomy, colectomy, hiatal hernia repair, …) except for uncomplicated appendectomy, splenectomy and inguinal hernia repair. 3. Medication use: 1. Any previous exposure to medication used in the treatment of motor symptoms of Parkinson's disease (levodopa, dopamine agonists, MAO-B inhibitors, COMT-inhibitors, NMDA-receptor antagonists, anticholinergics) 2. Antibiotics use in the last 3 months. 3. Use of PPI in the last month. 4. Use of NSAID in the last month. 5. Use of anticoagulation4 (including vitamin K antagonists (VKA), direct oral anticoagulants (DOAC) or low-molecular weight heparins (LMWH)) or dual antiplatelet therapy4 (DUAPT; Acetylsalicilic acid (Asaflow®) + P2Y12-inhibitor (Clopidogrel®)). 4. Pregnancy and breastfeeding. 5. Other: Cancer and/or adjuvant treatment within the last 6 months 6. Exposures: 1. Food intoxication in the last 3 months. 2. Consumptom of more than 2 standard units of alcohol per day. Patients (additional criteria) 1\. Neurological: any major neurological disorder other than Parkinson's disease. Controls (additional criteria) 1. Neurological: 1. A diagnosis of Parkinson's disease or any other major neurological disorder other than Parkinson's disease. 2. Clinical signs of parkinsonism. 3. First degree relative(s) with Parkinson's disease. 2. Gastrointestinal: subjects fulfilling a clinical diagnosis of either Functional dyspepsia, Functional constipation, or Irritable bowel syndrome based on the ROME-IV diagnostic criteria.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000, Belgium

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