Research Into the Expression of the csgA-gene and How it Changes in Patients With Parkinson's Disease

NCT07175922 | Recruiting

• 1 other identifier: VT-5006-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to understand the prevalence and variability of a gut bacteria gene called csgA in people with Parkinson's Disease. This understanding could inform development of potential new therapies targeting the gut in Parkinson's Disease.

Conditions

Parkinsons Disease (PD)

Outcome Measures

Primary Outcomes (2)

• csgA DNA

  Part A: The prevalence of detectable csgA DNA in stool samples from participants diagnosed with Parkinson's disease, as measured by polymerase chain reaction (PCR).

  Baseline stool sample

• csgA DNA

  Part B: The intra-individual and inter-individual variability in stool csgA DNA expression, measured over time, as measured by PCR.

  Weekly variability assessed over 4 weeks.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of Parkinson's disease within the last 10 years in the Netherlands

You may qualify if:

• Between 18-80 years of age at ICF signing (inclusive)
• A diagnosis of PD within 10 years from the time of ICF signing
• Current or history of gastrointestinal (GI) dysfunction or constipation based on screening assessment
• All participants must understand and provide written informed consent prior to any study specific procedures
• Able to speak, read, and understand study procedures in Dutch sufficiently to allow completion of all study assessments

You may not qualify if:

• Any known GI disorder if deemed clinically significant by the investigator. GI disorders may include, but are not limited to: Crohn's disease, ulcerative colitis, celiac disease, irritable bowel syndrome, or lactose intolerance
• Recent GI infection in the past 3 months if deemed clinically significant by the investigator.
• Major GI surgery (excluding appendectomy/cholecystectomy), such as bariatric surgery, gastrectomy, esophagectomy, vagotomy, small intestine surgeries, any type of colectomy, colostomy and anorectal surgeries if deemed clinically significant by the investigator
• Any known current or past eating disorder if deemed clinically significant by the investigator
• Use of systemic antibiotics within 30 days prior to enrollment

Sponsors & Collaborators

• Vertero Therapeutics: lead

Study Sites (1)

Center for Human Drug Research

Leiden, Netherlands

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

P.H.C. Kremer

CONTACT

+31 0715246400; clintrials@chdr.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: September 16, 2025
• Study Start: September 25, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)