Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Biological: PRIM-DJ2727
* Drug: Placebo (for PRIM-DJ2727)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis PD with a Hoehn and Yahr stage of < 3 in the Off medicine state Sexually active male and female subjects of child-bearing potential must agree to use an effective method of birth control during the treatment and follow-up period Female subjects of child-bearing potential must have a negative pregnancy test in the 72 hours before the procedure Subject willing to sign an informed consent form Subject deemed likely to survive for ≥ 1 year after enrolment Subject's attending physician will refer and provide non-transplant care for the subject Subjects must demonstrate adherence to and the ability to maintain a Parkinson's therapy medical regimen that is stable for 90 days before enrolment and participation in the study. Exclusion Criteria: Greater than 20 grams of ethanol intake daily Unstable Parkinson's disease Other immune disorder or clinical immunosuppression Probiotic used during study period Severe underlying disease such that the subject is not expected to survive for one or more years or unstable medical condition requiring frequent change in treatments Current or recent within one month receipt of an antibiotic with expected activity against enteric bacteria Prior Deep Brain Stimulation, or surgical intervention for PD , intravenous glutathione therapy or stem cell therapy HIV or Hepatitis B / C positive

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PRIM-DJ2727<br>Subjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules | Biological: PRIM-DJ2727<br>* Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules<br>|
| Placebo Comparator: Placebo<br>Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules | Drug: Placebo (for PRIM-DJ2727)<br>* Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecal microbiota transplantation