Parkinson's Trial NCT07175922
Develop gut therapies for 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
- Develop gut therapies for 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 how much week-to-week variation there is in a gut bacteria gene called csgA in people with Parkinson's who have had gut problems, information that could help guide development of future gut-targeted treatments. To do that, researchers will measure csgA and its activity in participants' gut bacteria over time; csgA makes curli, a bacterial amyloid produced by bacteria like Escherichia coli, and curli's similarity to human amyloid proteins may help explain how gut bacteria could trigger the protein clumping seen in Parkinson's. The study is enrolling adults 18 to 80 years old with a Parkinson's diagnosis within the past 10 years and a history of gastrointestinal dysfunction or constipation, while excluding people with major gut diseases, recent significant gut infections or surgeries, certain eating disorders, or use of systemic antibiotics in the past 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 how much week-to-week variation there is in a gut bacteria gene called csgA in people with Parkinson's who have had gut problems, information that could help guide development of future gut-targeted treatments. To do that, researchers will measure csgA and its activity in participants' gut bacteria over time; csgA makes curli, a bacterial amyloid produced by bacteria like Escherichia coli, and curli's similarity to human amyloid proteins may help explain how gut bacteria could trigger the protein clumping seen in Parkinson's. The study is enrolling adults 18 to 80 years old with a Parkinson's diagnosis within the past 10 years and a history of gastrointestinal dysfunction or constipation, while excluding people with major gut diseases, recent significant gut infections or surgeries, certain eating disorders, or use of systemic antibiotics in the past 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 6 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.