Untreated Parkinson's Disease Work-up Assessing Resident Microbiota and Duodenal Barrier Function (NCT07418658) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Untreated Parkinson's Disease Work-up Assessing Resident Microbiota and Duodenal Barrier Function
Belgium100 participantsStarted 2026-02
Plain-language summary
The UPWARD study is a prospective hypothesis-generating study in individuals with untreated Parkinson's disease (PD) and age-matched healthy controls (HCs). The objective of the study is to characterise disease-driven gastrointestinal (GI) changes that occur prior to initiation of treatment.
The main questions this study aims to answer are:
1. Are there changes in duodenal permeability in people with untreated PD?
2. Are there changes in the gut microbiome in people with untreated PD?
3. Are these gut changes linked to prodromal features, or movement and non-movement symptoms of PD?
The study consists of a screening visit, followed by a six-day home phase and one subsequent study visit at UZ Leuven. During the home phase, participants collect a stool sample, ingest radiopaque markers to assess gut transit time, and complete questionnaires. During the study visit, participants undergo an abdominal X-ray, a clinical assessment, and blood sampling. An upper GI endoscopy with duodenal biopsies is offered as an optional component of the study.
This study does not test a therapeutic intervention. Examinations as part of the study are not standard clinical care. The findings are expected to improve understanding of early GI involvement in PD and to inform future mechanistic and clinical research.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Diagnosis of Parkinson's Disease by a neurologist according to the Movement Disorder Society Clinical Diagnostic Criteria for PD
✓. Signed informed consent form
✓. Aged 18-75 years old
✓. Able to understand the study and questionnaires, and comply with study requirements
✓. Aged 40-75 years old
✓. Signed informed consent form
✓. Able to understand the study and questionnaires, and comply with study requirements
Exclusion criteria
✕. 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, …).
✕. Surgery: major abdominal surgery (including, but not limited to: cholecystectomy, colectomy, hiatal hernia repair, …) except for uncomplicated appendectomy, splenectomy and inguinal hernia repair.
What they're measuring
1
Paracellular flux
Timeframe: On day 7 (Follow-up visit)
2
Transepithelial electrical resistance (TEER)
Timeframe: On day 7 (Follow-up visit)
3
Fecal microbiota composition
Timeframe: Analyses wil be performed after storage of stool samples, collected during the at-home phase (day 1-6) preceding the Follow-up visit on day 7.
4
Duodenal microbiota composition
Timeframe: Analyses wil be performed after storage of duodenal samples, collected during the gastroduodenoscopy on day 7 (Follow-up visit).
✕. 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)
✕. Antibiotics use in the last 3 months.
✕. Use of PPI in the last month.
✕. Use of NSAID in the last month.
✕. 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®)).