Using fecal microbiota transplantation to treat constipation in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy and safety of fecal microbiota transplantation (FMT) for treating constipation in patients with Parkinson's disease. Participants are randomly assigned to receive either FMT capsules or placebo capsules for 24 weeks, with assessments conducted to measure improvements in constipation, emotional well-being, and quality of life. Fecal and blood samples will also be collected for further analysis of gut microbiota and levodopa levels. The study aims to provide insights into the potential benefits of FMT in managing gastrointestinal symptoms associated with Parkinson's disease.

Why it matters

Who can join: the full rules

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;

Where it's running

• 180 Fenglin Road
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Shengdi Wu — Fudan University
• Study coordinator: Shengdi Wu
• Email: wu.shengdi@zs-hospital.sh.cn
• Phone: (86)13817923359

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.