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RECRUITING
NCT06388863
NA

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

Sponsor: Shanghai Zhongshan Hospital

View on ClinicalTrials.gov

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

Interventions

DRUG

Healthy donor-derived FMT capsule

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

DRUG

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