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)
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.