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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT capsule group | Experimental | Participants will be given 6 FMT capsules twice a week for 24 weeks. The FMT capsules derived from healthy donors. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healthy donor-derived FMT capsule | Drug | Participants will be treated with healthy donor-derived fecal microbiota transplantation in the form of oral capsules. |
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| Measure | Description | Time Frame |
|---|---|---|
| Response rate of constipation in Parkinson's Disease (PD) | Efficacy index is calculated based on Wexner score. Efficacy index ≥30% is defined as response. | at week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at baseline and week 5, week 13 and week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shengdi Wu | Contact | (86)13817923359 | wu.shengdi@zs-hospital.sh.cn | |
| Xinyi Liu | Contact | liu.xinyi2@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Shengdi Wu | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 180 Fenglin Road | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Placebo capsule | Drug | Capsules whose appearance and smell are identical as FMT capsules but contain milk powder |
|
| 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. | 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. | 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. | 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 | 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. | 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. | at baseline, week 5, week 13 and week 24 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |