Parkinson's Disease
Conditions
Keywords
Fecal microbiota transplantation
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.
Interventions
BIOLOGICALPRIM-DJ2727
Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules
DRUGPlacebo (for PRIM-DJ2727)
Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules
Sponsors
Kelsey Research Foundation
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant | 3 years |
| Most abundant Phylum in Fecal Sample | 3 years |
| Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index | 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls | 3 years | — |
| Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares | 12 months | — |
| Memory as assessed by score on the Montreal Cognitive Assessment (MoCA) | 3 years | — |
| Number of bowel movements per day | 3 years | — |
| Neurologic functioning as indicated by score on the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | 3 years | The (MDS-UPDRS) measures mentation, behaviour, mood, activities of daily living and motor manifestations and the Montreal Cognitive Assessment (MoCA) for memory assessment. |
Outcome results
None listed