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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
a visually identical capsule containing skim milk powder
Oral capsules of lysophilized fecal microbiota
Kyung Hee University Hospital
Seoul, South Korea
Change from baseline in 39-Item Parkinson's Disease Questionnaire
The minimum score is 0 and the maximum score is 100, with higher scores indicating worse quality of life.
Time frame: Baseline up to Week 12
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Any adverse effects derived from the intervention
Time frame: up to 12 weeks
Change from baseline in Wexner Constipation Score
The minimum score is 0 and a maximum score is 30, with higher scores indicating more severe constipation.
Time frame: Baseline up to Week 12
Change from baseline in Bristol stool scale
The Bristol Stool Chart classifies stool types on a scale of 1 to 7, with 1 being the hardest and 7 being the most liquid.
Time frame: Baseline up to Week 12
Change from baseline in Geriatric Depression Scale-15 (short version)
The total score range is 0 to 15, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline up to Week 12
Change from baseline in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) with Hoehn and Yahr Stage (HYS)
The MDS-UPDRS has a total possible score of 260, with higher scores indicating greater disability. The HYS ranges from 0 to 5, or a clinical staging system that describes the progression of motor symptoms.
Time frame: Baseline up to Week 12
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