NCT06388863Recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 25 Apr 2024
- Start date
- 21 Feb 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Parkinson disease
- NCT number
- NCT06388863
What you commit to
- Study type: Interventional
- Planned participants: 76
- From 21 Feb 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have undergone surgery intervention due to PD;
- Immunodeficiency or treatment with immune-modulating medication;
- Have undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
- Use of probiotics or antibiotics within 1 month prior to study entry;
- Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;
Other illness
- Parkinsonism-plus syndrome;
- Stroke, brain trauma or epilepsy;
- Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
- Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
Other
- Pregnant, planning pregnancy or lactating;
Who the study is looking for
- Participants who fulfill Chinese diagnostic criteria for PD (2016 edition), aged 40-75 years;
- PD Hoehn-Yahr stage 1-3
- Participants who have at least 2 of the following symptoms in the past 3 months and the symptoms have been present for at least 6 months: ① More than 25% of defecations are laborious; ② More than 25% of defecations consist of hard or lumpy stools; ③ More than 25% of defecations are accompanied by a sensation of incomplete evacuation; ④ More than 25% of defecations are accompanied by a sensation of anorectal obstruction; ⑤ More than 25% of defecations require manual assistance; ⑥ Less than 3 spontaneous bowel movements per week.
- Have taken a stable dose of anti-Parkinson drugs, antidepressants and antipsychotics for at least 1 month;
- Absence of red flags such as weight loss, hematochezia and exclusion of other diagnosis;
- Have signed the informed consent and agree to participate in this study;
Age in the registry: 40 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| 180 Fenglin Road Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.