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Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease
Sponsor: Shanghai Zhongshan Hospital
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.
Official title: Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Parkinson's Disease Patients With Constipation
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2025-02-21
Completion Date
2027-12-31
Last Updated
2025-04-04
Healthy Volunteers
Yes
Conditions
Interventions
Healthy donor-derived FMT capsule
Participants will be treated with healthy donor-derived fecal microbiota transplantation in the form of oral capsules.
Placebo capsule
Capsules whose appearance and smell are identical as FMT capsules but contain milk powder
Locations (1)
180 Fenglin Road
Shanghai, Shanghai Municipality, China