RecruitingNCT07175922

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

Evaluation of csgA Prevalence, Gene Expression and Week-to-Week Variability in Participants With Parkinson's Disease and a History of Gastrointestinal Dysfunction


Sponsor

Vertero Therapeutics

Enrollment

200 participants

Start Date

Sep 25, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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

Exclusion Criteria5

  • 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 6 months prior to enrollment

Locations(1)

Center for Human Drug Research

Leiden, Netherlands

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NCT07175922


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