Parkinson DiseaseNCT06388863
Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease
A study testing Healthy donor-derived FMT capsule in people with Parkinson Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Healthy donor-derived FMT capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 21 Feb 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Parkinsonism-plus syndrome;
- Stroke, brain trauma or epilepsy;
- Have undergone surgery intervention due to PD;
- Pregnant, planning pregnancy or lactating;
- Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
- Immunodeficiency or treatment with immune-modulating medication;
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- Have undergone any abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy;
- Presence of uncontrolled diabetes, hypertension, thyroid disease or other systemic disease;
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xinyi Liu contact
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, Shanghai Municipality, 200032
Shengdi Wu, (86)13817923359, wu.shengdi@zs-hospital.sh.cn
Shengdi Wu
About this study
Official title: 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.
Read the detailed description
This prospective, double-blind, randomised, placebo-controlled study aims to evaluate efficacy and safety of fecal microbiota transplantation for constipation in Parkinson's disease. Participants will be given either FMT capsules or placebo capsules at a ratio of 1:1. For experimental 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. After 24-week treatment, participants complete specific scales to assess improvement in constipation, other PD symptoms, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa.
- Conditions
- Parkinson Disease
- Being tested
- Healthy donor-derived FMT capsule, Placebo capsule
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy donor-derived FMT capsuleDrug
Participants will be treated with healthy donor-derived fecal microbiota transplantation in the form of oral capsules.
Placebo capsuleDrug
Capsules whose appearance and smell are identical as FMT capsules but contain milk powder
| Study group | Role | What they receive |
|---|---|---|
| FMT capsule group | Experimental | Participants will be given 6 FMT capsules twice a week for 24 weeks. The FMT capsules derived from healthy donors. Receives: Drug: Healthy donor-derived FMT capsule |
| Placebo capsule group | Placebo comparator | Participants will be given 6 placebo capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell as FMT capsules but contain milk powder. Receives: Drug: Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of constipation in Parkinson's Disease (PD)
Efficacy index is calculated based on Wexner score. Efficacy index ≥30% is defined as response.
Measured: at week 24
Secondary outcomes (7)
Change from baseline PD symptoms at week 5, week 13 and week 24
PD symptoms are assessed via Unified Parkinson's Disease Rating Scale (UPDRS), PD Hoehn-Yahr grade, Non-Motor Symptoms Questionnaire (NMSQ). Change in PD symptoms is obtained by evaluating theses scales at baseline and week 5, week 13 and week 24.
Measured: at baseline and week 5, week 13 and week 24
Change from baseline anxiety at week 5, week 13 and week 24
Self-rating Anxiety Scale (SAS) is used to evaluate anxiety in PD patients, with a score ranging from 25 to 100. Higher score indicates higher level of anxiety. Change in SAS score is obtained by evaluating the scale at baseline, week 5, week 13 and week 24.
Measured: at baseline and week 5, week 13 and week 24
Change from baseline depression at week 5, week 13 and week 24
Self-rating Depression Scale (SDS) is used to evaluate depression in PD patients, with a score ranging from 25 to 100. Higher score indicates higher level of depression. Change in SDS score is obtained by evaluating the scale at baseline, week 5, week 13 and week 24.
Measured: at baseline and week 5, week 13 and week 24
Change from baseline quality of life at week 5, week 13 and week 24
Parkinson's disease Questionnaire (PDQ-39) is used to assess quality of life in PD patients. Higher score indicates worse life quality. Change in PDQ-39 score is obtained by evaluating the scale at baseline, week 5, week 13 and week 24.
Measured: at baseline and week 5, week 13 and week 24
Change from baseline drug concentration of levodopa in peripheral blood at week 13 and week 24
Blood samples are collected and tested for drug concentration of levodopa in peripheral blood
Measured: at baseline, week 13 and week 24
Change from baseline fecal microbiota based on metagenomics sequencing at week 5, week 13 and week 24
Fecal samples are collected at baseline, week 5, week 13 and week 24. Change in fecal microbiota is measured by metagenomics.
Measured: at baseline, week 5, week 13 and week 24
Change from baseline fecal metabolites based on non-targeted metabolomics at week 5, week 13 and week 24
Fecal samples are collected at baseline, week 5, week 13 and week 24. Change in fecal metabolites is measured by non-targeted metabolomics.
Measured: at baseline, week 5, week 13 and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start21 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shengdi Wu, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388863
- Sponsor's protocol ID
- B2024-002
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Parkinson's Disease Patients With Constipation
- ClinicalTrials.gov ID
- NCT06388863
- Acronym / sponsor ID
- B2024-002
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This prospective, double-blind, randomised, placebo-controlled study aims to evaluate efficacy and safety of fecal microbiota transplantation for constipation in Parkinson's disease. Participants will be given either FMT capsules or placebo capsules at a ratio of 1:1. For experimental 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. After 24-week treatment, participants complete specific scales to assess improvement in constipation, other PD symptoms, emotion and quality of life. Besides, fecal samples are collected for metagenomics and metabolomics sequencing and blood samples are tested peripheral concentration of levodopa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMT capsule group | Experimental | Drug: Healthy donor-derived FMT capsuleParticipants will be given 6 FMT capsules twice a week for 24 weeks. The FMT capsules derived from healthy donors. |
| Placebo capsule group | Placebo comparator | Drug: Placebo capsuleParticipants will be given 6 placebo capsules twice a week for 24 weeks. Placebo capsules are identical in appearance and smell as FMT capsules but contain milk powder. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- Parkinsonism-plus syndrome;
- Stroke, brain trauma or epilepsy;
- Have undergone surgery intervention due to PD;
- Pregnant, planning pregnancy or lactating;
- Psychiatric disorder or unable to cooperate with treatment and follow-up visit;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy donor-derived FMT capsuleParticipants will be treated with healthy donor-derived fecal microbiota transplantation in the form of oral capsules. | Drug | FMT capsule group |
| Placebo capsuleCapsules whose appearance and smell are identical as FMT capsules but contain milk powder | Drug | Placebo capsule group |
Primary outcome
Response rate of constipation in Parkinson's Disease (PD)
Time frame: at week 24
Efficacy index is calculated based on Wexner score. Efficacy index ≥30% is defined as response.
7 secondary outcomes
Change from baseline PD symptoms at week 5, week 13 and week 24
Time frame: at baseline and week 5, week 13 and week 24
Change from baseline anxiety at week 5, week 13 and week 24
Time frame: at baseline and week 5, week 13 and week 24
Change from baseline depression at week 5, week 13 and week 24
Time frame: at baseline and week 5, week 13 and week 24
Change from baseline quality of life at week 5, week 13 and week 24
Time frame: at baseline and week 5, week 13 and week 24
Change from baseline drug concentration of levodopa in peripheral blood at week 13 and week 24
Time frame: at baseline, week 13 and week 24
Change from baseline fecal microbiota based on metagenomics sequencing at week 5, week 13 and week 24
Time frame: at baseline, week 5, week 13 and week 24
Change from baseline fecal metabolites based on non-targeted metabolomics at week 5, week 13 and week 24
Time frame: at baseline, week 5, week 13 and week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinyi Liu contact
Shengdi Wu principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy donor-derived FMT capsule in people with Parkinson Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shengdi Wu ((86)13817923359, wu.shengdi@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate of constipation in Parkinson's Disease (PD) (time frame: at week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.