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

The University of Texas Health Science Center, Houston

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Parkinson's Disease

Interventions

PRIM-DJ2727BIOLOGICAL

Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules

Placebo (for PRIM-DJ2727)DRUG

Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules

Eligibility

Sex: ALLMin age: 45 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index

Time frame: 3 years

Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index

Time frame: 6 months

Microbiome Diversity in Fecal Samples s Indicated by the Shannon Diversity Index

Time frame: 12 months

Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant

Time frame: 3 years

Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant

Time frame: 6 months

Microbiome Richness in Fecal Samples as Indicated by the Number of Taxonomies per Participant

Time frame: 12 months

Most abundant Phylum in Fecal Sample

Time frame: 3 years

Most abundant Phylum in Fecal Sample

Time frame: 6 months

Most abundant Phylum in Fecal Sample

Time frame: 12 months

Secondary Outcomes

Improvements in flora diversity by oral administration of a fecal suspension from healthy donors comparing data with untreated controls

Time frame: 3 years

Number of bowel movements per day

Data from ClinicalTrials.gov

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Number of bowel movements per day

Time frame: 6 months

Number of bowel movements per day

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 12 months

Number of participants with a change in required anti-PD symptomatic or levodopa therapy

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 12 months

Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)

Time frame: 3 years

Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)

Time frame: day 1 of treatment

Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)

Time frame: 6 months

Memory as assessed by score on the Montreal Cognitive Assessment (MoCA)

Time frame: 12 months

Number of participants with worsening of PD symptoms or other potential flora-mediated disorders as indicated by patient diares

Time frame: 12 months