Link bacterial gene with constipation

Trial ID
NCT07175922
Official Title
Evaluation of csgA Prevalence, Gene Expression and Week-to-Week Variability in Participants With Parkinson's Disease and a History of Gastrointestinal Dysfunction
Goal
Link bacterial gene with constipation
Status
RECRUITING
Sponsor
Vertero Therapeutics
Study Type
OBSERVATIONAL
Enrollment
200 participants
Conditions
Parkinsons Disease (PD)

Plain-Language Summary

The goal is to find out how common and active a bacterial gene called csgA is in people with Parkinson's who have current or past gastrointestinal problems, and whether its levels change week to week. The approach is observational, using repeated stool samples to measure csgA prevalence and gene expression, since csgA makes bacterial amyloid proteins that in lab models can encourage alpha-synuclein to clump, so researchers want to see if gut bacterial activity lines up with PD-related gut symptoms. No treatment is given, the study just tracks microbiome signals and symptoms over time. They are looking for people age 18 to 80, diagnosed with Parkinson's within the past 10 years who have or had constipation or other GI dysfunction, must be able to complete study procedures in Dutch, and cannot have major GI disease, recent significant GI infection or surgery, certain eating disorders, or systemic antibiotic use in the prior 6 months.

Locations

  • Center for Human Drug Research, Leiden, Netherlands

Frequently Asked Questions

What is this trial testing?
This trial is studying an experimental treatment. The goal is to find out how common and active a bacterial gene called csgA is in people with Parkinson's who have current or past gastrointestinal problems, and whether its levels change week to week. The approach is observational, using repeated stool samples to measure csgA prevalence and gene expression, since csgA makes bacterial amyloid proteins that in lab models can encourage alpha-synuclein to clump, so researchers want to see if gut bacterial activity lines up with PD-related gut symptoms. No treatment is given, the study just tracks microbiome signals and symptoms over time. They are looking for people age 18 to 80, diagnosed with Parkinson's within the past 10 years who have or had constipation or other GI dysfunction, must be able to complete study procedures in Dutch, and cannot have major GI disease, recent significant GI infection or surgery, certain eating disorders, or systemic antibiotic use in the prior 6 months.
Who can participate?
Participants must be between 18 Years and 80 Years.
Where is this trial located?
This trial is recruiting at 1 location.
Does it cost anything to join?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This trial is estimated to last approximately 6 months.

View on ClinicalTrials.gov