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

The University of Texas System (UT) logo

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Withdrawn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)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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