Purpose

The purpose of this study is to characterize the intestinal microbiome in subjects with Parkinson's disease and to determine safety and trends in improvements in diversity of colonic microbiome following administration of lyophilized PRIM-DJ2727

Condition

Eligibility

Eligible Ages
Between 55 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Documented diagnosis of Parkinson's Disease (PD) for less than or equal to 10 years based on the United Kingdom Brain Bank Criteria and the Modified Hoehn-Yahr (H&Y) staging system of less than 3 in the "OFF medicine" state of at least 8-12 hours (subjects should have an asymmetric and unilateral symptoms onset).
  • Mild microsomia to anosmia (The University of Pennsylvania Smell Identification Test (UPSIT) less than 33), which is supportive of idiopathic PD.
  • Robust response to dopaminergic therapy (defined as greater than 33% reduction in symptoms (on the Unified Parkinson's Disease Rating Scale part III (UPDRS-III)) when measured in the ON medicine state compared to OFF state.
  • Subject has a history of constipation.
  • Sexually active male and female subjects of child-bearing potential agree to use an effective method of birth control during the study.
  • Female subjects of child-bearing potential must have a negative urine Qualitative Human chorionic gonadotropin (hCG) pregnancy test at enrollment and on the Week 1, Day 1 of the Treatment prior to administration of study drug.
  • Willing and able to sign an informed consent form and attend study assessments and follow ups.
  • Subject has an attending physician who will provide non-transplant care for the subject.
  • Subject is able to maintain a stable Parkinson's therapy medical regimen during participation in the study.

Exclusion Criteria

  • Unable to take multiple capsules orally.
  • Montreal Cognitive Assessment (MoCA) Score less than or equal to 23.
  • Atypical, vascular or drug-induced Parkinsonism.
  • Clinical features of psychosis or refractory hallucinations.
  • Unstable Parkinson's disease symptomatic therapy (defined as recent changes or additions to the PD regimen).
  • Compromised immune system (e.g. primary immune disorders or clinical immunosuppression due to a medical condition or medication e.g. taking systemic steroids greater than 20 milligrams (mg) a day or prednisone-equivalent)
  • Receipt of systemic non-topical antibiotic therapy currently or within 14 days of enrollment.
  • Prior Deep Brain Stimulation, or surgical intervention for PD, intravenous glutathione therapy or stem cell therapy.
  • History of medium or large vessel cerebrovascular accidents.
  • History of use of an investigational drug within 90 days prior to the screening visit.
  • Positive results for human immunodeficiency virus (HIV) or Hepatitis B / C.
  • Current history for active states of Inflammatory bowel disease, Irritable bowel syndrome, microscopic colitis, celiac disease, short gut syndrome, colostomy, colectomy, gastrointestinal fistulae or strictures.
  • History of significant uncontrolled systemic disease that in the opinion of the study investigator could interfere with study participation and/or objectives.
  • Life expectancy of less than 1 year.
  • In the opinion of investigator, subject for any reason, should be excluded from the study

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active group treated with healthy fecal microbiota
  • Drug: PRIM-DJ2727
    Twice filtered fecal microbiota product from three screened healthy donors will be lyophilized and encapsulated in enteric-coated capsules. Each dose of enteric coated capsules consists of 60 grams of stool and will be administered orally twice-weekly for 12 consecutive weeks
Experimental
Placebo group
  • Drug: Placebo oral capsule
    Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. The placebo will consist of Lactose (spray-dried United States Pharmacopeia (USP) 64.385gm), food color, powdered Black, Brown, and Yellow in the enteric capsules. Placebo will be administered orally twice-weekly for 12 consecutive weeks

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Zhi-Dong Jiang, Dr.PH
713-500-9371
zhi-dong.jiang@uth.tmc.edu

More Details

NCT ID
NCT03671785
Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Herbert L DuPont, MD
713 500 9366
herbert.l.dupont@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.