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.
Drug: Placebo (for PRIM-DJ2727)
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Full eligibility criteria for NCT03026231
Ages eligible for Study
45 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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
All locations for NCT03026231
View full eligibility
Tris trial is registered with FDA with number: NCT03026231. The sponsor of the trial is The University of Texas Health Science Center, Houston and it is looking for 0 volunteers for the current phase.
Official trial title: 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
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