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

• Status: Withdrawn
• Trial end date: 2018-07-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: Kelsey Research Foundation

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