Tests fecal microbiota capsules for constipation in Parkinson's disease
Tests donor gut bacteria capsules against placebo in people with Parkinson's and constipation.
Plain-language title generated from the registry record
Registry title: Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease
Key facts
- Where
- Shanghai, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Source: NCT06388863, who can take part
Where in China
- 180 Fenglin RoadShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Zhongshan Hospital
- Trial code
- NCT06388863
- Record updated
- 4 April 2025
- Original description
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.Read full original descriptionShow less
Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Parkinson's Disease Patients With Constipation
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.
Inclusion: 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.
Exclusion: 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; 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; Pregnant, planning pregnancy or lactating.