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Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease - Trial NCT06388863

Access comprehensive clinical trial information for NCT06388863 through Pure Global AI's free database. This phase not specified trial is sponsored by Shanghai Zhongshan Hospital and is currently Not yet recruiting. The study focuses on Parkinson Disease. Target enrollment is 76 participants.

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NCT06388863
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Trial Details
ClinicalTrials.gov โ€ข NCT06388863
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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

Study Focus

Parkinson Disease

Healthy donor-derived FMT capsule

Interventional

drug

Sponsor & Location

Shanghai Zhongshan Hospital

Shanghai, China

Timeline & Enrollment

N/A

Jun 01, 2024

May 31, 2026

76 participants

Primary Outcome

Response rate of constipation in Parkinson's Disease (PD)

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.

ICD-10 Classifications

Parkinson disease
Parkinsonism in diseases classified elsewhere
Dementia in Parkinson disease
Secondary parkinsonism
Secondary parkinsonism, unspecified

Data Source

ClinicalTrials.gov

NCT06388863

Non-Device Trial