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

The University of Texas System (UT)

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Parkinson's Disease

Treatments: Drug: Placebo (for PRIM-DJ2727); Biological: PRIM-DJ2727

Study type: Interventional

Funder types: Other

Identifiers

NCT03026231

UT-SPH/KRF FMT-2016-PD-01

Details and patient eligibility

About

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.

Sex: All

Ages: 45 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 2 patient groups, including a placebo group

PRIM-DJ2727

Active Comparator group

Description:

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

Treatment:

Biological: PRIM-DJ2727

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo (for PRIM-DJ2727)