Actively Recruiting
Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease
Led by Shanghai Zhongshan Hospital · Updated on 2025-04-04
76
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants diagnosed with Parkinson's disease according to Chinese diagnostic criteria (2016 edition), aged 40 to 75 years
- Parkinson's disease Hoehn-Yahr stage 1 to 3
- Experienced at least two constipation symptoms for at least 6 months, including laborious defecation, hard or lumpy stools, sensation of incomplete evacuation, anorectal obstruction, manual assistance required, or fewer than 3 spontaneous bowel movements per week
- On a stable dose of anti-Parkinson drugs, antidepressants, and antipsychotics for at least 1 month
- No red flag symptoms such as weight loss or blood in stool and exclusion of other diagnoses
- Provided informed consent and agreed to participate in the study
You will not qualify if you...
- Diagnosis of Parkinsonism-plus syndrome
- History of stroke, brain trauma, or epilepsy
- Previous surgical intervention for Parkinson's disease
- Pregnant, planning pregnancy, or breastfeeding
- Psychiatric disorders or inability to cooperate with treatment and follow-up
- Immunodeficiency or receiving immune-modulating medication
- Previous abdominal surgery except for appendectomy, cholecystectomy, cesarean section, or hysterectomy
- Uncontrolled diabetes, hypertension, thyroid disease, or other systemic diseases
- Use of probiotics or antibiotics within 1 month prior to study entry
- Severe diseases related to heart, brain, kidney, or lung, or presence of malignancies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
180 Fenglin Road
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
S
Shengdi Wu
CONTACT
X
Xinyi Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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