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study will be started under a new modified protocol
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| Name | Class |
|---|---|
| Kelsey Research Foundation | OTHER |
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The purpose of this study is to characterize the intestinal flora in subjects with Parkinson's Disease (PD) and to determine safety and trends in improvements in diversity of colonic microbiome following fecal microbiota transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRIM-DJ2727 | Active Comparator | Subjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules |
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| Placebo | Placebo Comparator | Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRIM-DJ2727 | Biological | Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index | 3 years | |
| Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index | 6 months | |
| Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index | 12 months | |
| Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant | 3 years | |
| Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant | 6 months | |
| Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant | 12 months | |
| Most abundant Phylum in Fecal Sample | 3 years | |
| Most abundant Phylum in Fecal Sample | 6 months | |
| Most abundant Phylum in Fecal Sample | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls | 3 years | |
| Number of bowel movements per day | 3 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herbert L DuPont, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23852569 | Background | Borody TJ, Paramsothy S, Agrawal G. Fecal microbiota transplantation: indications, methods, evidence, and future directions. Curr Gastroenterol Rep. 2013 Aug;15(8):337. doi: 10.1007/s11894-013-0337-1. | |
| 23712625 | Background | Fasano A, Bove F, Gabrielli M, Petracca M, Zocco MA, Ragazzoni E, Barbaro F, Piano C, Fortuna S, Tortora A, Di Giacopo R, Campanale M, Gigante G, Lauritano EC, Navarra P, Marconi S, Gasbarrini A, Bentivoglio AR. The role of small intestinal bacterial overgrowth in Parkinson's disease. Mov Disord. 2013 Aug;28(9):1241-9. doi: 10.1002/mds.25522. Epub 2013 May 27. |
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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 (for PRIM-DJ2727) | Drug | Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules |
|
| Number of bowel movements per day |
| 6 months |
| Number of bowel movements per day | 12 months |
| Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment. | 3 years |
| Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment. | 1 day |
| Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment. | 6 months |
| Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment. | 12 months |
| Number of participants with a change in required anti-PD symptomatic or levodopa therapy | 12 months |
| Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39) | 3 years |
| Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39) | day 1 of treatment |
| Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39) | 6 months |
| Subject assessment of global improvement in PD and quality of life as indicated by score the self-survey Parkinson's Disease Questionnaire 39 (PDQ-39) | 12 months |
| Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) | 3 years |
| Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) | day 1 of treatment |
| Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) | 6 months |
| Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) | 12 months |
| Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares | 12 months |
| 26428310 | Background | Nakane S, Yoshioka M, Oda N, Tani T, Chida K, Suzuki M, Funakawa I, Inukai A, Hasegawa K, Kuroda K, Mizoguchi K, Shioya K, Sonoda Y, Matsuo H. The characteristics of camptocormia in patients with Parkinson's disease: A large cross-sectional multicenter study in Japan. J Neurol Sci. 2015 Nov 15;358(1-2):299-303. doi: 10.1016/j.jns.2015.09.015. Epub 2015 Sep 8. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |