NCT07038226

Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkinson's Disease

Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkinson's Disease: a Double-blind, Placebo-controlled, Randomised Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Kyung Hee University Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this clinical trial is to assess the impact of fecal microbiota transplantation (FMT) delivered via oral capsules in patients with Parkinson's disease who suffer from refractory constipation. The primary questions this trial seeks to answer are: Does FMT delivered through oral capsules improve constipation? Does FMT delivered through oral capsules enhance the motor symptoms associated with Parkinson's disease? Is FMT delivered through oral capsules safe for individuals with Parkinson's disease? Researchers will compare the intervention group with a control group to determine the presence of a placebo effect. Participants in the study will: Take antibiotics as a pre-treatment regimen for 5 days, followed by oral capsules containing either fecal microbiota or a placebo for 14 days. Attend clinic visits at screening, visit 1 (baseline), visit 2 (4 weeks), and visit 3 (12 weeks). Collect fecal samples and maintain a 2-week diary of their bowel habits before visits 1, 2, and 3.

Conditions

• Parkinson Disease
• Constipation

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	a visually identical capsule containing skim milk powder
BIOLOGICAL	Oral capsule-delivered FMT	Oral capsules of lysophilized fecal microbiota

Timeline

• Start date: 2023-10-02
• Primary completion: 2025-04-30
• Completion: 2025-05-30
• First posted: 2025-06-26
• Last updated: 2025-06-26

Locations

1 site across 1 country: South Korea