Trial | NCT03026231  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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 Started
Jul 15
2017
Anticipated
Primary Completion
Jul 17
2018
Study Completion
Jul 17
2018
Last Update
Aug 10
2018

Biological PRIM-DJ2727

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

Drug Placebo (for PRIM-DJ2727)

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

PRIM-DJ2727 Active Comparator

Subjects with PD will be randomly assigned to receive PRIM-DJ2727 in orally administered enteric-coated capsules

Placebo Placebo Comparator

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

Criteria 

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
No Results Posted