Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07418658
Eligibility Criteria:
\* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07418658
Study Brief:
Protocol Section:
NCT07418658