Healthy donor-derived FMT capsule for Parkinson's (NCT06388863)
Improve constipation with fecal transplant
- Trial ID
- NCT06388863
- Official Title
- Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Parkinson's Disease Patients With Constipation
- Goal
- Improve constipation with fecal transplant
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Shanghai Zhongshan Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 76 participants
- Conditions
- Parkinson Disease
- Interventions
- Healthy donor-derived FMT capsule, Placebo capsule
Summary For Families
Looking to see if giving healthy donor gut bacteria can relieve the chronic constipation many people with Parkinson's have, while checking safety and any ripple effects on Parkinson's symptoms. Treatment is oral capsules of donor-derived fecal microbiota or placebo, intended to reshape the gut microbiome to normalize bowel movements and reduce gut inflammation, and because gut bacteria can change levodopa absorption the trial requires stable Parkinson's medications so any changes can be tracked. Enrolling adults 40 to 75 with diagnosed PD at Hoehn-Yahr stage 1 to 3 who meet specific chronic constipation criteria, have been on stable anti-Parkinson meds, and who do not have recent antibiotics, major systemic illness, immunodeficiency, or other listed exclusions.
Locations
- 180 Fenglin Road, Shanghai, Shanghai Municipality, China
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Healthy donor-derived FMT capsule. Looking to see if giving healthy donor gut bacteria can relieve the chronic constipation many people with Parkinson's have, while checking safety and any ripple effects on Parkinson's symptoms. Treatment is oral capsules of donor-derived fecal microbiota or placebo, intended to reshape the gut microbiome to normalize bowel movements and reduce gut inflammation, and because gut bacteria can change levodopa absorption the trial requires stable Parkinson's medications so any changes can be tracked. Enrolling adults 40 to 75 with diagnosed PD at Hoehn-Yahr stage 1 to 3 who meet specific chronic constipation criteria, have been on stable anti-Parkinson meds, and who do not have recent antibiotics, major systemic illness, immunodeficiency, or other listed exclusions.
- Who can participate?
- Participants must be between 40 Years and 75 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 1 year and 10 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 trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Blood draw (minimally invasive). Confirm the full schedule with the study coordinator.