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

Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Parkinson's Disease Patients With Constipation

This study is testing whether a treatment using gut bacteria from healthy donors can help people with Parkinson's disease who struggle with constipation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Zhongshan Hospital (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06388863 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-75 with a diagnosis of Parkinson's disease and specific constipation symptoms.

Not a fit: Patients with advanced Parkinson's disease or those with other gastrointestinal disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve constipation and overall quality of life for patients with Parkinson's disease.

How similar studies have performed: While the use of fecal microbiota transplantation is a novel approach in this context, similar studies have shown promising results in other gastrointestinal conditions.

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;

Where this trial is running

Shanghai, Shanghai Municipality

• 180 Fenglin Road — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Shengdi Wu — Fudan University
• Study coordinator: Shengdi Wu

Conditions Parkinson Disease