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| ID | Type | Description | Link |
|---|---|---|---|
| 2022 | Other Grant/Funding Number | CN Research Foundation |
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| Name | Class |
|---|---|
| Kyungpook National University Hospital | OTHER |
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The aim of this clinical trial is to assess the impact of fecal microbiota transplantation (FMT) delivered via oral capsules in patients with Parkinson's disease who suffer from refractory constipation. The primary questions this trial seeks to answer are:
Does FMT delivered through oral capsules improve constipation? Does FMT delivered through oral capsules enhance the motor symptoms associated with Parkinson's disease? Is FMT delivered through oral capsules safe for individuals with Parkinson's disease? Researchers will compare the intervention group with a control group to determine the presence of a placebo effect.
Participants in the study will:
Take antibiotics as a pre-treatment regimen for 5 days, followed by oral capsules containing either fecal microbiota or a placebo for 14 days.
Attend clinic visits at screening, visit 1 (baseline), visit 2 (4 weeks), and visit 3 (12 weeks).
Collect fecal samples and maintain a 2-week diary of their bowel habits before visits 1, 2, and 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive a visually identical capsule containing skim milk powder. |
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| Oral capsule-delivered FMT | Experimental | Participants will receive oral capsules of lysophilized fecal microbiota. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Biological | a visually identical capsule containing skim milk powder |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 39-Item Parkinson's Disease Questionnaire | The minimum score is 0 and the maximum score is 100, with higher scores indicating worse quality of life. | Baseline up to Week 12 |
| Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Any adverse effects derived from the intervention | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Wexner Constipation Score | The minimum score is 0 and a maximum score is 30, with higher scores indicating more severe constipation. | Baseline up to Week 12 |
| Change from baseline in Bristol stool scale |
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Inclusion Criteria:
A. On at least 1 out of 4 bowel movements, two or more of the following apply: i. Excessive straining.
ii. Lumpy/hard stools (Bristol Stool Form Scale 1-2). iii. Sensation of incomplete evacuation after defecation. iv. Sensation of anorectal obstruction or blockage. v. Manual maneuvers to facilitate defecation. vi. Fewer than three spontaneous bowel movements per week. B. Rarely experience loose stools without the use of laxatives. C. Symptoms began at least 6 months prior to diagnosis and have persisted for the past 3 months.
D. Constipation shows no improvement despite the use of various types of laxatives (bulk-forming, osmotic, saline, stimulant, or others) individually or in combination for at least 4 weeks.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Block randomization is performed by an unblinded Clinical Research Associate (CRA), assigning participants to either the treatment group or the placebo group in a 1:1 ratio. All other researchers involved in the study remain blinded to group assignments. The researcher responsible for randomization does not engage in any other aspects of the research process. Randomization records are maintained separately from other clinical data to ensure confidentiality. Researchers, aside from the one handling randomization, are unaware of which participants are in the treatment or placebo group.
| Oral capsule-delivered FMT |
| Biological |
Oral capsules of lysophilized fecal microbiota |
|
The Bristol Stool Chart classifies stool types on a scale of 1 to 7, with 1 being the hardest and 7 being the most liquid.
| Baseline up to Week 12 |
| Change from baseline in Geriatric Depression Scale-15 (short version) | The total score range is 0 to 15, with higher scores indicating more severe depressive symptoms. | Baseline up to Week 12 |
| Change from baseline in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) with Hoehn and Yahr Stage (HYS) | The MDS-UPDRS has a total possible score of 260, with higher scores indicating greater disability. The HYS ranges from 0 to 5, or a clinical staging system that describes the progression of motor symptoms. | Baseline up to Week 12 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |