Parkinson's Trial NCT07567794
Studying gut changes predicting Parkinson
- Trial ID
- NCT07567794
- Official Title
- Consortium for Gut-Brain Communication in Parkinson's Disease Master Protocol
- Goal
- Studying gut changes predicting Parkinson
- Status
- RECRUITING
- Sponsor
- Duke University
- Study Type
- OBSERVATIONAL
- Enrollment
- 250 participants
- Conditions
- Parkinson Disease (PD), PARKINSON DISEASE (Disorder), Gut Microbiome, Gut Microbiota, Prodromal Parkinsons Disease
- Registry Record Last Updated
- 2026-07-31 (this month)
- Estimated Commitment
- Moderate commitment estimated from the protocol (based on: invasive procedure, 6 study visits). This reflects time and procedures only — confirm details with the study coordinator.
Summary For Families
The goal is to find out how the nerves that connect the gut and brain are involved in Parkinson's, by comparing people with Parkinson's to people at risk and to people without the disease to spot gut-related differences that may come before or follow neurological symptoms. The approach is detailed observation: participants meet with providers, answer questionnaires, and give blood, stool, saliva, skin, and lower-colon tissue samples; they also have X-rays of swallowing and colon transit, a flexible sigmoidoscopy biopsy, and tests of rectal muscle function, with assessments repeated over a 24-month period. Adults 21 to 80 are being enrolled into three groups, people with Parkinson's (mild, moderate, or severe), people at risk such as those with a sleep disorder that causes acting out dreams plus reduced smell, and household controls without neurodegenerative disease, while people with major cognitive impairment, active inflammatory gut disease, certain bleeding risks for the sigmoidoscopy, recent cancer, or other serious medical problems are excluded.
Eligibility at a Glance
Key requirements found in this trial's official criteria, in plain language. Only what the listing states is shown; the study team makes the final call.
- Disease stage: Stage 4 on the Hoehn and Yahr scale
- Thinking test (MoCA): MoCA memory and thinking score of at least 22 (criteria text: "Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score \<22")
- Healthy volunteers: Also accepts people without Parkinson's (healthy volunteers) (criteria text: "CT.gov structured field: healthyVolunteers")
Do I Likely Qualify? — Self-Check Dimensions
The trial page offers an interactive self-check built from this trial's parsed criteria. It covers these dimensions; anything the criteria don't state clearly is answered "ask the study coordinator", never assumed.
- This trial enrolls people aged 21 to 80.
- This trial requires Hoehn and Yahr stage 4.
- This trial requires a MoCA thinking-test score of at least 22.
Locations
- Stanford University, Stanford, California, United States
- Rush University, Chicago, Illinois, United States
- University of Chicago, Chicago, Illinois, United States
- Massachusetts General Hospital, Boston, Massachusetts, United States
- Mayo Clinic, Rochester, Minnesota, United States
- Columbia University, New York, New York, United States
- Medical University of South Carolina, Charleston, South Carolina, United States
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07567794. It is the one about "Studying gut changes predicting Parkinson". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: Assessments are scheduled at baseline, 6, 12, 18, and 24 months. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: 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. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying an experimental treatment. The goal is to find out how the nerves that connect the gut and brain are involved in Parkinson's, by comparing people with Parkinson's to people at risk and to people without the disease to spot gut-related differences that may come before or follow neurological symptoms. The approach is detailed observation: participants meet with providers, answer questionnaires, and give blood, stool, saliva, skin, and lower-colon tissue samples; they also have X-rays of swallowing and colon transit, a flexible sigmoidoscopy biopsy, and tests of rectal muscle function, with assessments repeated over a 24-month period. Adults 21 to 80 are being enrolled into three groups, people with Parkinson's (mild, moderate, or severe), people at risk such as those with a sleep disorder that causes acting out dreams plus reduced smell, and household controls without neurodegenerative disease, while people with major cognitive impairment, active inflammatory gut disease, certain bleeding risks for the sigmoidoscopy, recent cancer, or other serious medical problems are excluded.
- Who can participate?
- Participants must be between 21 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 7 locations.
- Does it cost anything to join?
- Being asked to pay to join a trial is a red flag: legitimate trials do not charge a participation fee, and the study treatment and study-specific tests are provided by the trial sponsor. What you might still pay depends on where you live: in the US, routine care you would receive anyway can be billed to you or your insurance; 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 2 years and 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.
- How many visits does this trial involve?
- Assessments are scheduled at baseline, 6, 12, 18, and 24 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Biopsy (invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.