NCT06388863 Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease
| NCT ID | NCT06388863 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2025-02-21 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 76 participants in total. It began in 2025-02-21 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Participants who fulfill Chinese diagnostic criteria for PD (2016 edition), aged 40-75 years; 2. PD Hoehn-Yahr stage 1-3 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. 4. Have taken a stable dose of anti-Parkinson drugs, antidepressants and antipsychotics for at least 1 month; 5. Absence of red flags such as weight loss, hematochezia and exclusion of other diagnosis; 6. Have signed the informed consent and agree to participate in this study; Exclusion Criteria: 1. Parkinsonism-plus syndrome; 2. Stroke, brain trauma or epilepsy; 3. Have undergone surgery intervention due to PD; 4. Pregnant, planning pregnancy or lactating; 5. Psychiatric disorder or unable to cooperate with treatment and follow-up visit; 6. Immunodeficiency or treatment with immune-modulating medication; 7. Have undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy; 8. Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease; 9. Use of probiotics or antibiotics within 1 month prior to study entry; 10. Presence of severe diseases related to heart, brain, kidney and lung or concomitant malignancies;
Contact & Investigator
Shengdi Wu
PRINCIPAL INVESTIGATOR
Fudan University
Frequently Asked Questions
Who can join the NCT06388863 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06388863 currently recruiting?
Yes, NCT06388863 is actively recruiting participants. Contact the research team at wu.shengdi@zs-hospital.sh.cn for enrollment information.
Where is the NCT06388863 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06388863 clinical trial?
NCT06388863 is sponsored by Shanghai Zhongshan Hospital. The principal investigator is Shengdi Wu at Fudan University. The trial plans to enroll 76 participants.
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