Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease Patients
Phase 1
Withdrawn
- Conditions
- Parkinson's Disease
- Interventions
- Biological: PRIM-DJ2727Drug: Placebo (for PRIM-DJ2727)
- Registration Number
- NCT03026231
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PRIM-DJ2727 PRIM-DJ2727 Subjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules Placebo Placebo (for PRIM-DJ2727) Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules
- Primary Outcome Measures
Name Time Method 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 12 months Most abundant Phylum in Fecal Sample 12 months
- Secondary Outcome Measures
Name Time Method 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 12 months Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) 12 months The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment.
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) 12 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