drugset / Trial / NCT06388863

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

NCT06388863

Recruiting 76 enrolled Shanghai Zhongshan Hospital
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2025-02-21
Primary completion
2026-12-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Ornidazole Other / unclassified 6 unknown Oral

Indications