RecruitingNot ApplicableNCT06388863

Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease

Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Parkinson's Disease Patients With Constipation


Sponsor

Shanghai Zhongshan Hospital

Enrollment

76 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Participants will be allocated to FMT group or placebo group at a 1:1 ratio. For interventional group, patients will be given six FMT capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell but contain milk powder. At each follow-up visits, participants complete specific scales to assess improvement in constipation, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa.


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests fecal microbiota transplantation (FMT) — a procedure that transfers healthy gut bacteria from a donor — to help relieve constipation in people with Parkinson's disease. Parkinson's patients frequently experience severe, ongoing constipation that is hard to treat with standard laxatives. **You may be eligible if...** - You are between 40 and 75 years old with a diagnosis of Parkinson's disease (Hoehn-Yahr stage 1–3, meaning mild to moderate) - You have had chronic constipation symptoms for at least 6 months (e.g., straining, hard stools, fewer than 3 bowel movements per week) - Your Parkinson's medications have been stable for at least 1 month **You may NOT be eligible if...** - You have a Parkinson's-plus syndrome (a related but different condition) - You have had a stroke, brain injury, or epilepsy - You have had abdominal surgery other than appendectomy, gallbladder removal, C-section, or hysterectomy - You are pregnant, planning pregnancy, or breastfeeding - You have an immune deficiency or take immune-suppressing medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHealthy donor-derived FMT capsule

Participants will be treated with healthy donor-derived fecal microbiota transplantation in the form of oral capsules.

DRUGPlacebo capsule

Capsules whose appearance and smell are identical as FMT capsules but contain milk powder


Locations(1)

180 Fenglin Road

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06388863


Related Trials