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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-15

Study Completion Date

2018-07-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Fecal Microbiota Transplantation in the Treatment of Parkinson's Disease With Constipation

NCT04837313

Parkinson's Disease Fecal Microbiota Transplantation

RECRUITING NA

Fecal Microbiota Transplantation Via Oral Capsule for Treating Refractory Constipation in Parkinson's Disease

NCT07038226

Parkinson Disease Constipation

COMPLETED NA

Fecal Microbiota Transplantation As a Potential Treatment for Parkinson's Disease

NCT03876327

Parkinson Disease

COMPLETED PHASE2/PHASE3

Evaluation of the Efficacy and Safety of Fecal Microbiota Transplantation for Constipation in Parkinson's Disease

NCT06388863

Parkinson Disease

RECRUITING NA

Effect of Fecal Microbiota Transfer on Progression of Parkinson Disease

NCT05204641

Parkinson Disease

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PRIM-DJ2727

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

Group Type ACTIVE_COMPARATOR

PRIM-DJ2727

Intervention Type BIOLOGICAL

Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo (for PRIM-DJ2727)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PRIM-DJ2727

Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules

Intervention Type BIOLOGICAL

Placebo (for PRIM-DJ2727)

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No